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Archive for the ‘Personalized Medicine’ Category

USA Equities Corp (USAQ), Announces Revenues of $120000 for the 4th Quarter of 2020 and Projects Revenues in excess of $300000 for the 1st Quarter of…

Saturday, January 2nd, 2021

WEST PALM BEACH, FL, Dec. 30, 2020 (GLOBE NEWSWIRE) -- USA EQUITIES CORP. (OTCQB: USAQ) (the Company, we, or our) announced today that its revenues for the fourth quarter of 2020 would be approximately $120,000 and that its revenues would exceed $300,000 in the first quarter of 2021.

We introduced our QHSLab, Software as a Service (SaaS) platform, to 159 medical practices in June 2020. Through September, physicians in these practices provided 374 allergy patients with a QHSLab-generated allergen immunotherapy prescription, generating an estimated $664,608 in revenue for these physicians practices. In November, building on the capabilities of our QHSLab, we began shipping allergy diagnostic related products and immunotherapy treatments to these physicians in response to their requests based upon courses of treatment recommended for their patients by QHSLab. Our revenue in the fourth quarter will be $120,000 as a result of these sales. Based upon orders in hand and reasonably anticipated, revenues from our allergy diagnostic test kits and treatment programs should exceed $300,000 in the first quarter of 2021. Revenues from this program should continue to increase thereafter as we increase the number of physicians and medical practices utilizing QHSLab.

Based on our QHSLab allergy treatment systems success, we intend to increase our revenues by charging physicians a monthly subscription fee for the use of QHSLab. USAQ plans to introduce these physicians to additional point of care diagnostic, digital medicine, and treatments that our physician clients can use and prescribe. They will be paid under existing government and private insurance programs, based upon analyses conducted utilizing QHSLab.

The revenues we generated in the fourth quarter of 2020 and anticipated revenue in the first quarter of 2021 far exceed the revenue levels assumed by the equity research firm, Litchfield Hills Research, when it released its first analyst coverage report on USAQ. Litchfield Hills continue to rate our stock as a buy under its three-tiered rating system, with a target price of $5.00 per share.

About USA Equities Corp (OTCQB: USAQ)

On December 20, 2019 USA Equities Corp completed a share exchange whereby it acquired Medical Practice Income, Inc. (MPI). The Company is focused on value-based healthcare solutions, clinical informatics and algorithmic personalized medicine including digital therapeutics, behavior based remote patient monitoring, chronic care and preventive medicine. The Companys products are intended to allow the general practice physician to increase his revenues by cost effectively diagnosing and treating chronic diseases generally referred to specialists. The Companys products and information service portfolio are directed towards prevention, early detection, management, and reversal of cardio-metabolic and other chronic diseases. Our principal objectives are to develop proprietary software tools, devices, and approaches, providing more granular, timely, and specific clinical decision-making information for practicing physicians and other health care providers to address todays obese, diabetic and cardiovascular disease population. The Company is located in West Palm Beach, Florida. For more information, visit http://www.MedicalPracticeIncome.com/discover.

Forward-Looking Statements

Certain matters discussed in this press release are 'forward-looking statements' intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. In particular, the Company's statements regarding trends in the marketplace, future revenues, future products and potential future results and acquisitions, are examples of such forward-looking statements. Forward-looking statements are generally identified by words such as may, could, believes, estimates, targets, expects, or intends and other similar words that express risks and uncertainties. These statements are subject to numerous risks and uncertainties, including, but not limited to, the timing of the introduction of new products, the inherent discrepancy in actual results from estimates, projections and forecasts made by management, regulatory delays, changes in government funding and budgets, and other factors, including general economic conditions, not within the Company's control. The factors discussed herein and expressed from time to time in the Company's filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

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USA Equities Corp (USAQ), Announces Revenues of $120000 for the 4th Quarter of 2020 and Projects Revenues in excess of $300000 for the 1st Quarter of...

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Revisiting Late-Onset Asthma: Clinical Characteristics and Association | JAA – Dove Medical Press

Saturday, January 2nd, 2021

Santiago Quirce,1 Enrico Heffler,2 Natalia Nenasheva,3 Pascal Demoly,4 Andrew Menzies-Gow,5 Ana Moreira-Jorge,6 Francis Nissen,7 Nicola A Hanania8

1Department of Allergy, La Paz University Hospital, IdiPAZ and Universidad Autnoma de Madrid, Madrid, Spain; 2Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center, IRCCS, Rozzano, MI, Italy; 3Department of Allergology and Immunology of Russian Medical Academy for Continuous Medical Education, Moscow, Russian Federation; 4Department of Pulmonology, Division of Allergy, Hpital Arnaud de Villeneuve, University Hospital of Montpellier, Montpellier, France; 5Department of Respiratory Medicine, Royal Brompton Hospital, London, UK; 6Novartis Farmaceutica, S.A., Barcelona, Spain; 7London School of Hygiene and Tropical Medicine, London, UK; 8Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA

Correspondence: Santiago QuirceHospital Universitario La Paz, P. La Castellana, 261, Madrid, 28046 SpainEmail squirce@gmail.com

Abstract: The Global Initiative for Asthma (GINA) 2020 defines late-onset asthma (LOA) as one of the clinical phenotypes of asthma wherein patients, particularly women, present with asthma for the first time in adult life, tend to be non-allergic and often require higher doses of inhaled corticosteroids (ICS) or are relatively refractory to corticosteroid treatment. In this review, we examine the published literature improve the understanding of the following aspects of LOA: 1) the age cut-off for its diagnosis; 2) its distinct clinical phenotypes, characteristics and risk factors; and 3) its association with allergic comorbidities and conditions. Overall, our review reveals that clinicians and researchers have used multiple age cut-offs to define LOA, with cut-off ages ranging from > 12 years to 65 years. LOA has also been classified into several distinct phenotypes, some of which drastically differ in their clinical characteristics, course and prognosis. Although LOA has traditionally been considered non-allergic in nature, our review indicates that it is commonly associated with allergic features and comorbidities. Our findings suggest that there is an urgent need for the development of more clear clinical practice guidelines that can provide more clarity on the definition and other aspects of LOA. In addition, the association of LOA and allergy needs to be re-examined to frame a more optimal treatment strategy for patients with LOA.

Keywords: asthma, diagnosis, age of onset, allergy, allergic asthma, asthma phenotypes

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Creative Medical Technology Holdings Announces Reversion of Liver Failure Using ImmCelz Personalized Cellular Immunotherapy in Preclinical Model -…

Saturday, January 2nd, 2021

PHOENIX, Dec. 29, 2020 /PRNewswire/ --(OTC-CELZ)Creative Medical Technology Holdings Inc. announced today novel data and patent filing No. 63131261 describing the ability of ImmCelz to reverse liver failure in the carbon tetrachloride preclinical model of hepatocyte necrosis.

These findings are the basis for a patent filing covering various means of generating the ImmCelz product in a hepatoprotective specific manner. The Company has previously reported that ImmCelz is capable of treating animal models of stroke,1 as well as inducing "immunological tolerance" in a model of autoimmune rheumatoid arthritis.2

The work is an extension of previously published findings of Dr. Thomas E. Ichim, in which mesenchymal stem cells were capable of inhibiting progression of liver failure.3

"I am proud of the work the team at Creative Medical Technologies is conducting in advancing the concept of immunologically-mediated regeneration,"said Dr. Ichim, Co-inventor of the patent. "ImmCelz is an advancement on our previous liver failure work due to the fact that we have shown transfer of regenerative activity from the stem cell to the immune cell. Immune cells possess ability to home to injured tissues faster than stem cells due to their smaller size. Additionally, immune cells possess immunological memory, which we believe may be applied to the concept of regeneration."

"While stem cell therapeutics are recognized as the future of medicine, I believe it is important to realize that many activities of stem cells are mediated by changes to the immune system," said Dr. Amit Patel, Board Member of the Company and Co-Inventor of the Patent Application. "ImmCelz represents a fundamental advancement in regenerative medicine in that instead of administering stem cells in the body to induce immune modulation, we actually optimize the immune modulation in the laboratory before injecting immune cells into the patient."

Being at the forefront in identifying novel regenerative treatment options, the Company possesses numerous issued patents in the area of cellular therapy, including patent no. 10,842,815 covering use of T regulatory cells for spinal disc regeneration, patent no. 9,598,673 covering stem cell therapy for disc regeneration, patent no. 10,792,310 covering regeneration of ovaries using endothelial progenitor cells and mesenchymal stem cells, patent no. 8,372,797 covering use of stem cells for erectile dysfunction, and patent no. 7,569,385 licensed from the University of California covering a novel stem cell type.

"Liver failure represents a significant unmet medical need and I am extremely excited that ImmCelz has the potential to help the numerous patients on the liver transplant waiting list who currently have no other option.

With growing validation and acceptance of such technologies, the company intends to continue to broaden its intellectual property portfolio by compiling research data and filing patents, in order to record early filing dates and increase the likelihood of our receiving patent issue.

We continue to welcome opportunities with collaborators and Key Opinion Leaders as we are dedicated to accelerating the further development of our technology."

About Creative Medical Technology Holdings

Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in stem cell technology in the fields of urology, neurology and orthopedics and trades on the OTC under the ticker symbol CELZ. For further information about the company, please visitwww.creativemedicaltechnology.com.

Forward Looking Statements

OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website atwww.sec.gov.

Creativemedicaltechnology.comwww.StemSpine.comwww.Caverstem.comwww.Femcelz.com

1 Creative Medical Technology Holdings Identifies Mechanism of Action of ImmCelz Stroke Regenerative Activity (prnewswire.com)2 Creative Medical Technology Holdings Reports Positive Preclinical Data on ImmCelz Immunotherapy Product in Rheumatoid Arthritis Model | BioSpace 3 Human endometrial regenerative cells alleviate carbon tetrachloride-induced acute liver injury in mice | Journal of Translational Medicine | Full Text (biomedcentral.com)

SOURCE Creative Medical Technology Holdings, Inc.

http://creativemedicaltechnology.com

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The technological transformations that marked 2020 – Mint

Saturday, January 2nd, 2021

On 1 January 2020, I published my very first Ex Machina article of the year. Since it was also the beginning of a new decade, I made my own modest attempt at predicting the technological changes we could hope to expect in the coming years. I wrote about the promise of artificial intelligence, speech recognition and augmented reality, and how they would come together to let us speak to computers in novel ways. I argued that technology would transform our commute, eventually leading to a future of shared autonomous vehicles that would completely eliminate the need to own personal cars, etc. Finally, I spoke of personalized medicine and a future in which treatments could be calibrated to individual requirements, instead of being focused on discovering drugs that need to work on the entire human population.

What I did not predict was that in a couple of months, a global pandemic would bring the entire world to a grinding halt.

Much of what I had thought would happen will likely still come to passalthough in a slightly different way from what I had imagined. Now that companies have realized how easy it is to support working from home, many businesses are re-thinking their investments in commercial real estatecommitting themselves instead to enabling employees to work from wherever they might be at a given point in time.

In addition to all that I had anticipated, I believe this new mindset will eventually contribute to a fundamental alteration of our commute and be another catalyst for some of the urban mobility solutions. I had anticipated. And while autonomous transportation may not become a reality anytime soon, I am excited by the immediate promise that platform solutions of the likes of Beckn have to offer.

I had suggested in my article that computers might soon be able to speak coherently with us, but even I did not imagine wed get there so soon. The remarkable language abilities of OpenAIs Generative Pre-trained Transformer Ver 3 (GPT-3) technology took the world by storm this year. But while initial reports suggested that it would make computer communications indistinguishable from human speech, closer study revealed flaws in its output, as also practical limitations in working with very large data-sets. That said, I was heartened by the emergence of new techniques of artificial intelligence such as few-shot learning, and the promise that it could hold for data-starved countries like India.

But the technology breakthrough that everyone was focused on for all of 2020 was in medicine. On this front, my prediction at the beginning of the year fell well short of the mark. As hopeful as I still am for a future in which medicine will be personalized, the covid pandemic made it clear that there will always be a need for medical solutions that can be rolled out rapidly and at scale to the entire global population.

I am thankful that our investments in genetic technologies, the global interconnectedness of the scientific community and the manufacturing capabilities of pharmaceutical companies came together so well this past year to enable us to produce multiple vaccines for covid-19 in record time. I hope these demonstrations of success encourage us to invest in platform vaccine technologies, so that we are better placed to deal with such challenges that we will, no doubt, continue to face in the future.

But, more than anything else, the pandemic demonstrated the central role that technology now plays in society. From the contact-tracing apps that were all the rage in the early months of the diseases outbreak, to the remote-working solutions that brought us together even though we were far apart, it is clear that all aspect of our lives today are dependent on technology.

Our recent experiences will hopefully serve as the impetus we need to make sure that small businesses and ordinary citizens in this country get greater access to the internet, so that they can all partake in this future.

Early in the lockdown, the department of telecommunications relaxed the work-from-home restrictions that applied to technology companies registered as Other Service Providers (OSP)a relaxation that was made permanent before the end of the year with a radical overhaul of the entire OSP framework. Later in the year, the Union cabinet approved the Prime Minister Wi-Fi Access Network Interface, or PM Wani , a new regulation system for wifi that will encourage the rapid proliferation of digital technologies in India.

As good as these regulatory measures might be, we still need key technology legislation to bring us on par with the rest of the world. It was good to see that despite the constraints imposed by the pandemic, the meetings of the Joint Parliamentary Committee on data protection proceeded apace. Equally interesting was the governments interest in regulating non-personal data, making India the first country to attempt governing the entire data landscape.

As gruesome as the year has been, it has forced us to reconsider our relationship with technologyand to engage with it in different ways.

Rahul Matthan is a partner at Trilegal and also has a podcast by the name Ex Machina. His Twitter handle is @matthan

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Predictive Oncology Announces Cancellation of Special Meeting in December 2020Reincorporation Proposal Received Overwhelming Support Among Shares…

Saturday, January 2nd, 2021

NEW YORK, Dec. 29, 2020 (GLOBE NEWSWIRE) -- Predictive Oncology (NASDAQ: POAI) (the Company), a knowledge-driven company focused on applying artificial intelligence (AI) to personalized medicine and drug discovery, today announced that its Board of Directors has decided to cancel its Special Meeting of Stockholders that was originally scheduled for December 1, 2020. On that date, the meeting was adjourned to December 30, 2020 because a quorum was not reached. As of December 30, 2020, approximately 47% of the outstanding shares as of the record date have been voted, and therefore a quorum has still not been reached. The Board of Directors has determined that it is not practical to incur the expense of adjourning the meeting further to continue to solicit proxies, because approval of the reincorporation proposal would require the affirmative vote of a majority of the Companys outstanding shares (not simply a majority of the shares voted).

The Board notes that, of the shares that were voted at the Special Meeting, nearly 88% of the shares were voted FOR the reincorporation from Delaware to Nevada. In the future, the Board intends to continue to seek stockholder approval for reincorporation, due in part to the oppressive franchise taxes charged by Delaware.

About Predictive Oncology Inc.

Predictive Oncology (NASDAQ: POAI) operates through three segments (Skyline, Helomics and Soluble Biotech), which contain four subsidiaries: Helomics, TumorGenesis, Skyline Medical and Soluble Biotech.

Helomics applies artificial intelligence to its rich data gathered from patient tumors to both personalize cancer therapies for patients and drive the development of new targeted therapies in collaborations with pharmaceutical companies. TumorGenesis Inc. specializes in media that help cancer cells grow and retain their DNA/RNA and proteomic signatures, providing researchers with a tool to expand and study cancer cell types found in tumors of the blood and organ systems of all mammals, including humans. Skyline Medical markets its patented and FDA cleared STREAMWAY System, which automates the collection, measurement and disposal of waste fluid, including blood, irrigation fluid and others, within a medical facility, through both domestic and international divisions. Soluble Biotech is a provider of soluble and stable formulations for proteins including vaccines, antibodies, large and small proteins and protein complexes.

Forward-Looking Statements

Certain matters discussed in this release contain forward-looking statements. These forward-looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, plans and objectives of management are forward-looking statements. The words anticipate, believe, estimate, expect, intend, may, plan, would, target and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors including, among other things, factors discussed under the heading Risk Factors in our filings with the SEC. Except as expressly required by law, the Company disclaims any intent or obligation to update these forward-looking statements.

Investor Relations Contact:

Hayden IRJames Carbonara(646)-755-7412

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Worldwide Industry for Microbiome Sequencing Services to 2025 – Increased Focus on Human Microbiome Therapy is Driving Growth – ResearchAndMarkets.com…

Saturday, January 2nd, 2021

The "Global Microbiome Sequencing Services Market (2020-2025) by Technology, Application, Research Type, Laboratory Type, End-Users, Geography and the Impact of Covid-19 with Ansoff Analysis" report has been added to ResearchAndMarkets.com's offering.

The Global Microbiome Sequencing Services Market is estimated to be USD 1.02 billion in 2020 and is expected to reach USD 2.31 billion by 2025, growing at a CAGR of 17.8%.

Microbiomes are a group of micro-organisms living on a human body. They live on the skin, eyes, saliva, mouth, and the gastrointestinal tract. The human microbiome contains thousands of bacterial species/microbes in diverse communities, along with their genes, proteins, and metabolites. An imbalance of these microbes can lead to life-threatening diseases. The study of Microbiome sequencing and its techniques relates to the study of the microbial composition of the human gut and to understand the resulting impact on health and disease development.

Microbiome sequencing is usually done to understand this microflora residing on the human body and further study human microbes and their role in related diseases. This study can also be helpful while analyzing the patient's response to a particular treatment. Effective understanding and application of microbiome sequencing services would help in the commercialization of personalized medicine and diet. Hence, the market is extensively driven by research-based communities, especially in the developed economies like the US, which has the presence of NHGRI (National Human Genome Research Institute) supporting the growth of the market.

Due to advancements in technology, there has been a rise in the NGS (Next-Gen Sequencing) to generate microbiome data. Besides, techniques such as novel high-throughput sequencing and new software tools are transforming microbiome studies by providing service at high quality, speed, and high cost. Many companies are additionally concentrating on novel exome sequencing and RNA sequencing applications in niche market segments.

Story continues

Specific factors that have led to the growth of this market are the rising use of microbiome in genomics, along with the reduced cost of sequencing. However, other factors such as the lack of expertise in the data analysis for the microbiomes with advanced tools shall hinder the growth of this market.

Market Dynamics

Drivers

Increased Focus on Human Microbiome Therapy

Reduction in the Cost of Sequencing

Human Microbiome as a New Validated Target for Drug Development

Human Microbiome Used as an Aid for Early Disease Detection and Diagnosis

Increasing Demand for NGS

Restraints

Lack of Skilled Professionals for Microbiome Sequencing Services

Lack of Awareness Among Physicians and Scientist about Advanced Tools for Data Analysis

Barriers in Proving the Causal Link Between Dysbiosis and Disease

Opportunities

Investigational New Drug (IND) Requirements for Fecal Microbiota

Increasing Collaborations Create Growth Opportunities

Increasing Research Investments and Technological Advancements

Why Buy this report?

The report offers a comprehensive evaluation of the Global Microbiome Sequencing Services Market. - The report includes in-depth qualitative analysis, verifiable data from authentic sources and projections about market size. The projections are calculated using proven research methodologies.

The report has been compiled through extensive primary and secondary research. The primary research is done through interviews, surveys and observation of renowned personnel in the industry.

The report includes in-depth market analysis using Porter's 5 force model and the Ansoff Matrix. The impact of Covid-19 on the market is also featured in the report.

The report also contains a competitive analysis using IGR Positioning Quadrants, Infogence's Proprietary competitive positioning tool.

Companies Mentioned

Baseclear B.V.

Clinical-Microbiomics A/S

Molzym GmbH & Co. Kg

Zymo Research Corp.

Rancho Biosciences

Microbiome Therapeutics, LLC.

Microbiome Insights Inc.

Openbiome

Resphera Biosciences, LLC.

MR DNA (Molecular Research LP)

Shanghai Realbio Technology Co., Ltd

Diversigen, Inc.

Merieux Nutrisciences Corporation

Metabiomics Corp.

Second Genome

LOCUS BIOSCIENCES, INC,

BioSpherex LLC

For more information about this report visit https://www.researchandmarkets.com/r/6xv3hj

View source version on businesswire.com: https://www.businesswire.com/news/home/20201229005159/en/

Contacts

ResearchAndMarkets.comLaura Wood, Senior Press Managerpress@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470For U.S./CAN Toll Free Call 1-800-526-8630For GMT Office Hours Call +353-1-416-8900

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After accepting virtual trainers, AI-powered nutrition is the next step in keeping a healthy lifestyle – Geektime

Saturday, January 2nd, 2021

The day comes for all of us, and the day Im speaking of is that day when our once loose jeans and baggy shirt become a bit tighter around the waste. Its at that time we decide to get down to business, hit the gym, and skip the cookie aisle at the supermarket, because the diet starts now.

COVID hits and its not that easy to get our work out on. Still we wake every morning and go for a run, even buy weights, do the research and plan out are meals. After chugging down a protein shake, suddenly losing those extra pounds feels easy. However, then, with the runners high wearing off, a bag of Cheetos, a few beers, and more than one off-day later, and you realize that this is going to be an uphill battle.

Israeli startup Newt and its founder and CEO Gil Kerbs understand the struggle of maintaining a healthy diet and schedule. The company developed an AI-powered platform that uses your daily habits to generate a personalized regiment to keep your nutritional goals on track. Or as Gil puts it Our product interacts with users daily to understand and aggregate all information needed for health / nutrition based decisions, and then provides daily support to start shifting their behavior towards healthier habits.

With the year of COVID coming to a hopeful end, it was definitely a great year for remote technology, from medicine to fitness, the global pandemic did change the way people interact virtually. So how has personalized nutrition gained such popularity? GIl says that It's kind of the 'perfect storm'. We are so focused on our health and wellbeing due to the pandemic - we finally REALLY know that actively staying fit and healthy can help prevent harsh impacts from sickness, such as with COVID. We are also witnessing the rise of AI, allowing for true personalization - a personal fitness coach that is really 'personal', and now with Newt, a personal nutritionist that really tailors everything for you.

Gil explains that he sees preventative care as the future of personalized medicine, not only giving you the 'right' medicine when you need it but rather helping you make the right daily decisions that eventually shape your long term health.

Yeah, this is probably not the first fitness/nutrition app youve heard of, but Newt does things a little different, actually putting your habits in the center to better motivate you. But how is it done? In one word - "behavioral personalization". We are not aiming for a quick perfect, but for the closest to optimal that you can sustain for the long run. Our Behavioral expertise stretches from Prof. Adam Grant (Wharton, world leading motivation expert), and Stanford Mind&Body lab who focus on use of psychology for wellbeing. Our goal is to make not only the best clinical knowledge available, but rather to combine it with cutting edge psychology/behavior knowledge that makes behavior and diet change a real possibility in the long run."

Gils attachment to the subject comes from his years in the medical industry as part of Medtronic China, where he notes that it was very rewarding to help add 1-2 years to people's lives, but I wanted more - 20-30 more years, with better quality - and this could not be done when the patient is already in the OR. So, I got into preventative medicine, and there's nothing bigger for your long term health than your nutrition... All of us at Newt have this motivation - helping people keep healthy, by harnessing the strongest force available to everyone - daily nutrition."

He adds that although intervention healthcare isnt going anywhere and will maintain an important part of medical care but preventative can be better for humanity as a whole, Take cancer - surgery's solution is to take it out or 'kill it' (radiation), but not to solve what caused it, yet. This is a short term solution due to the limitations of our knowledge. Think about it this way - 5 year survival rates for various cancers are still very low, despite utilizing cutting edge technology to treat them. Preventative healthcare is much less 'high-tech', we don't need robots - nor huge amounts of dollars - it's rather cheap - and it really helps dramatically reduce chances of getting sick. The real problem is that it's a marathon, and not just a sprint intervention, making it psychologically harder. That's why we at Newt focus on behavior so much.

Founded in 2019, Newt has received backing from Welltech1 - a wellness microfund, and angel investors. And according to Gil, the company has a few partnerships in the works. Cool idea and all but why the name Newt? We wanted something short that sounds like nutrition, but is also a name of a character. We see Newt as a personal guide for nutrition. It's also a really cute animal, said Kerbs.

Ok, last thing, even though its been a weird year, were sure people will keep in the tradition of failing at their New Years resolutions (myself a victim), so we asked Gil to take from his nutritional expertise and offer some advice: ...In general I'd advise people that next time they 'fail' with a resolution, they should not beat themselves up about it, but rather think how to better approach it next time. Usually, there's a fun, easier way to achieve success and give you great results in the long run.

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Predictions for AI-powered digital healthcare in 2021 – MedCity News

Monday, December 28th, 2020

Apart from efforts to develop vaccines for Covid-19, 2020 has been a year of substantial advancements in artificial intelligence (AI) and machine learning technologies that are being applied in healthcare as never before, resulting in improvements and enhancements in diagnosis and treatment that were previously impossible.

These technologies are advancing at an increasing rate, and we can be sure that AI will be used even more to overcome healthcare challenges in 2021 and beyond. Here are some of the main areas AI will be used to enhance digital healthcare in the near future.

OncologyMany healthcare practices today, including cancer diagnosis, still rely heavily on manual activities and processes and even those that do utilize digital technologies use them on an independent basis, not under one integral environment. Pathology, the medical specialty of diagnosing disease in patients, most notably cancer, is a good example. Traditional pathology involves manual processes that have remained unchanged for years, where glass slides with tissue samples are analyzed by pathologists using microscopes.

But that is changing today with a growing trend of moving toward digitized infrastructures and workflows (for example digital pathology). This trend is expected to accelerate as a result of the Covid-19 pandemic, increasingly saving time and labor costs while providing better and more cost-effective care. Moreover, adding an AI layer to an already digitized workflow can help make processes even more efficient on several fronts, including:

Triage: AI tools can help determine which cases should be reviewed more urgently and which physicians or resources to assign to them. This will ensure that each case is diagnosed by the physician whose capabilities can best be applied to the situation at hand, assigning cases based on a physicians sub-specialty or level of experience, which becomes especially important in complex cases.

Diagnosis: AI tools can also help with cancer diagnosis and assessment, pointing instantly to particular areas of interest, for instance those that include cancerous cells, and signaling the needle in the haystack factor that can shed light on a patients situation and what may be required to treat them. As a result, turnaround times for case reporting to the referring physician can be reduced significantly. In addition, smart AI tools will allow for the automation of some diagnostic tasks that are currently performed manually, such as counting cells, measuring features and automatically filling up parts of the report.

Next-generation diagnostics: With advanced machine learning capabilities and as more digital datasets become available, AI tools will be able to analyze more data and thus provide more insight than is currently possible. These tools will go beyond mimicking a physicians diagnosis; AI models will integrate extensive amounts of data from diverse sources (e.g., imaging, pathology and clinical data), acting as a sort of tumor board, where experts from multiple fields share their findings and knowledge to decide on the most accurate diagnosis and treatment. In the near future, we can expect to see AI serve as the perfect companion to the physician, with an unparalleled ability to combine huge amounts of fragmented information accurately and effectively.

Telehealth and Physician AccessThe need for quality healthcare keeps growing with an aging population and an increase in disease incidence. The number of physicians, however, does not grow at the same rate, and this creates a supply gap particularly evident for certain medical sub-specialties, in far-flung rural communities and sometimes even in urban centers. AI-based telehealth for instance, a new generation of affordable and accurate sensing devices that can be used to examine, monitor or diagnose patients remotely, as well as new communication technologies such as AI-based chatbots will help transform a visit to the doctors office into a completely different experience, enabling a more effective, frequent and affordable physician access for patients. The pandemic, with its frequent quarantines and regional lockdowns, only demonstrated the importance of these technologies as well as the shift needed in the mindset of all stakeholders: patients, physicians, providers and payers.

Personalized MedicineWith all the advancements in medical science, prognostic assessments and treatment decisions are many times not much better than a shot in the dark. For example, up to 75% of oncology patients (in a number of cancer types) do not respond to at least one of the available treatment drugs. Developing new biomarkers and genomic tests to more accurately predict prognosis and enable physicians to choose the right treatment is a costly, unpredictable, and painfully slow process.

Enter AI. Biomarkers based on artificial intelligence and machine learning can be an important, cost-effective and efficient way to develop tools for precision medicine. AI algorithms could provide new prognostic insights and help oncologists stratify patients into smaller, more homogeneous groups and assist in selecting personalized treatment for each patient based on a multitude of data types. These algorithms will combine pathology, radiology, genomic, clinical and demographic data, and analyze huge databases of medical records, treatments and outcomes. AI-driven solutions could also provide a more accurate and objective analysis of medical data, leading to new computational tests that replace or augment todays molecular tests.

Quality ControlObviously an essential part of any quality-driven system, quality control is a real challenge in labor-intensive processes. For example, for pathologists diagnosing cancer, an effective near bulletproof quality control requires having a second pathologist review the same biopsy again a time consuming and costly task. As a result, we find many clinical processes where quality control is done only on a small fraction of cases, if at all, often failing to detect errors.

AI and advanced algorithms can help create concurrent processes that rapidly review medical procedures and diagnoses, detecting mistakes early enough to avoid any damage. Fast and automated AI tools will enable pathology labs for the first time to apply rigid quality control standards to all their cases. Currently, the majority of cases are viewed by a single pathologist in almost all labs, which means that errors and misdiagnosed cancers may not be detected on time. AI can help transform this completely.

Algorithms can also alert on inconsistent findings, making sure the different medical disciplines provide a coherent picture of the patients condition and treatment plan, and that there are no holes in the process. An electronic medical record (EMR) that contains all the medical information of a patient could be constantly monitored by AI whenever something suspicious is detected, such as a lab test result that is inconsistent with a previous diagnosis, or a drug prescription that does not match the patients condition, the AI would highlight the inconsistency, prompting a thorough review by the relevant physician.

Screening ProtocolsDecisions on issues like which patient should be sent for a specific test CT, MRI, colonoscopy and others are currently conducted based on demographics or other general variables that often have nothing to do with a patients medical record. Going forward, we will see more medical screening thats based on specific characteristics identified by AI algorithms trained on large providers datasets. Such predictive algorithms will identify specific patterns, risk factors or correlations between multiple variables using advanced machine learning techniques.

Science-based medicine is one of the miracles of the modern age; lives are being saved today that just a few years ago would have been unsalvageable, and new, advanced treatments are providing a much better quality of life for many more than would have been possible in the past. Still, there are many domains in medicine and healthcare that could benefit from adopting the latest developments in artificial intelligence and machine learning and we see their role in improving healthcare becoming ever more important in the future.

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Predictions for AI-powered digital healthcare in 2021 - MedCity News

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The Increasing Use Of AI In The Pharmaceutical Industry – Forbes

Monday, December 28th, 2020

The pharmaceutical industry has long relied on cutting edge technologies to help deliver safe, reliable drugs to market. With the recent pandemic, its proved more important than ever for pharmaceutical companies to get drugs and vaccines to market faster than ever before.

Subroto Mukherjee, Head of Innovation and Emerging Technology, Americas at GlaxoSmithkline Consumer ... [+] Healthcare

Artificial intelligence and machine learning have been playing a critical role in the pharmaceutical industry and consumer healthcare business. From augmented intelligence applications such as disease identification and diagnosis, helping identify patients for clinical trials, drug manufacturing, and predictive forecasting, these technologies have proven critical. On a recent episode of the AI Today podcast Subroto Mukherjee, who is Head of Innovation and Emerging Technology, Americas at GlaxoSmithkline Consumer Healthcare discussed how AI and ML are being applied to the pharmaceutical industry and some unique use cases for AI and ML technology. In this follow up interview he shares his insights in more detail.

How is AI currently being applied in the pharmaceutical industry?

Subroto Mukherjee: AL and ML have been critical in the pharmaceutical industry and consumer healthcare business. AI and ML are playing an important role during this pandemic, driven by COVID and the race to discover effective vaccines. The top-level uses in Pharma and Consumer Healthcare arena as follows:

Apart from the Healthcare conditions, we see many AI ML usage in Digital Transformation areas for Pharma and Healthcare companies such as Martech, AdTech, Supply Chain, Sales, and Customer Service.

What are some unique use cases for AI and ML technology in the pharmaceutical industry?

Subroto Mukherjee: As per the article in guardian-Artificial intelligence group,DeepMindhas cracked a serious scientific problem that has stumped researchers for half a century. AlphaFold, the company and research laboratory using the AI program, showed it could predict how proteins fold into 3D shapes. The advantage of this discovery is that it will help researchers discover the mechanisms that drive some diseases and pave the way for - designer medicines, more nutritious crops, and "green enzymes" that can break down plastic pollution.

Another unique case and my favorite and involved in enabling the GSK consumer R&D team is AI in Sensory Science. AI and ML are ramping up predicting parameters in foods, beverages, agriculture, andmedicine. This could lead to hyper-personalized products for food, beverage, and medicines customized for different demographics and ethnicities; we extensively usesensoryproperties beyond taste, such as smell, appearance, and texture, influencing what we select to eat or drink.

Can you share use cases where AI was successfully applied at GlaxoSmithKline?

Subroto Mukherjee: Let me share some use cases in our consumer healthcare line of business.

Predictive Forecasting:We have popular seasonal brands in the Allergy and Cold and Flu category. The business use case is to have a predictive model that predicts how the upcoming season for allergy or cold and flu would shape up in different regions, and when are the predicted peaks and troughs. The advantage of this information is to inform consumers on our brand.com website, improve our national and regional media delivery and inform retailers of seasonal activation timing (distribution, stock up, display and secondary support).

Sensory Models Humans react differently, to taste, size, texture, color, and Sensory AI models help in a holistic way of understanding, predicting, and optimizing consumer preference. We use multiple parameters, such as taste, texture, color, and ML models, to understand the relationship between the consumer and the desired product experience. Our brands offer gummies, tablets, and liquids for our over-the-counter products, and these models are beneficial.

AI in eye-tracking:We do studies with our consumers and retailers in our shoppers science lab and monitor how they look at our products while they shop online or in stores. Consumers and retail teams with consent in our labs wear eye-tracking glasses and look at the products on shelf or online. During this process, images are captured and analyzed using AI. The analysis includes Areas of Interest (AOI) metrics, including the time to first fixation and time spent, gaze plots, heatmaps, and video replays. This helps in better product placement, improves our art and labeling, and helps us understand consumer behavior.

What are some of the challenges to AI adoption at larger organizations?

Subroto Mukherjee: Key challenges to AI adoption at larger organizations are as follows:

What are some of the challenges around data privacy, security, ethics, and transparency that organizations such as GSK are dealing with?

Subroto Mukherjee: Data privacy and security are of the highest importance for our organization. We constantly ensure all data privacy, security laws are followed, and appropriate training is provided across our different portfolios and adhered to by our partners and complementary workers. Data classification (PII, CSI, Sensitive), adherence of our systems, and processes to the GDPR or California privacy rights act's needs are some of the challenges we constantly face.

For AI ethics and transparency, we make sure MLOps processes are in place, and Machine learning (ML) models model scoring is established, monitoring and drift detection, the feedback loop is transparently followed. We bring a diverse ML team with diverse experience embedded in the team and test the models constantly to bring transparency and remove bias from the Machine learning models.

The global pandemic has really shaken up the pharma industry. How are you seeing AI and machine learning being put to use in the fight against the pandemic?

Subroto Mukherjee: Concerning the pandemic the biggest use of AI and machine learning from my understanding is to tease out COVID's biological secrets and identify the few molecules which will help end COVID among the millions and to reduce the time to market drugs either be discovery, development to clinical trials and final FDA approvals. Look at the speed and agility of the current vaccine it took 300 days from identifying the coronavirus genome to the first vaccine study, which has previously taken an average of eight to ten years.

Medical Mining - Let me focus on one specific initiative - "US White House - Call to Action." to analyze and Transform COVID-19 Data into Clinical Knowledge. White House is partnering with the AI research community to understand the novel coronavirus by mining medical literature. Natural language processing is one of the fastest-growing practices in this area, helping with this initiative. Medical imaging companies using AI and ML claimed record-level accuracy in detecting covid-induced pneumonia from CT scans, despite concerns from some stakeholders on the quality of training data.

Another important impact of COVID-19 is the impact of the supply chain. All companies, including ours, are facing the impact of COVID in the supply chain and manufacturing. Be it the supply of raw material or distribution of finished goods, it helps in pre-empting the risks associated with it. Companies are scrambling to respond to rapidly shifting consumer demand, limited supply of some products, and new workplace rules. AI and ML are used in Planning and Forecasting, Bots for automation and collaboration, and many key areas of the value chain.

How do large organizations approach change management for transformative technologies such as AI?

Subroto Mukherjee: We are implementing agile transformation across the business to create an effective and simple change management structure. Our technology organization, business team, and leadership team have undergone agile training. The change management discipline has been re-oriented with a clear hierarchy of approvals (key decision-makers) for onboarding new AI technology solutions. We define clear business objectives and value for now, next, and later for these transformative technologies.

What do you see as critical needs for workforce development around AI?

Subroto Mukherjee: We need reskilling and education among the workforce, not only in technical aspects but also in AI's business value. AI for Good or AI ethics is another key aspect that employees and the business community need to understand. Workers should not be afraid of AI, but rather embrace it and understand the benefits of AI. In terms of workforce, organizations need to scale up slowly with monitored results and a pool of data scientists knowing the business, data engineers, and subject matter experts.

How is the global regulatory environment impacting the pharma industrys adoption of AI?

Subroto Mukherjee: It is necessary to meet compliance and regulatory requirements as regulators need to safeguard consumers, and it does impact the timelines of new AI solutions to be rolled out. But organizations should be collaborating with regulators to streamline this process to the benefit of all. Both regulators and pharma companies can embrace AI and other digital transformation initiatives to drive the economy, cost efficiency, and value-driven effectiveness of regulatory operations.

What AI technologies are you most looking forward to in the coming years?

Subroto Mukherjee: I am looking forward to the advancement and extended use of Natural language processing, Robotics, Speech, and computer vision in the coming years.

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The Increasing Use Of AI In The Pharmaceutical Industry - Forbes

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The global metabolomics market size is projected to reach USD 4.1 billion by 2025 from USD 1.9 billion in 2020, at a CAGR of 13.4% – GlobeNewswire

Monday, December 28th, 2020

New York, Dec. 24, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Metabolomics Market by Product, Application, Indication, End User - Global Forecast to 2025" - https://www.reportlinker.com/p04763096/?utm_source=GNW However, issues related to data examination & data processing in metabolomics and the high cost of tools and instruments are likely to restrain the market growth to a certain extent.

By Product & Service, the metabolomics instrument accounted for the largest share of the metabolomics market.

The metabolomics instrument segment is expected to account for the largest market share in 2020. Factors such as the technological advancements in analytical instruments in terms of miniaturization, automation, and computerization; increase in the number of research-related activities worldwide in the field of medicine, nutraceuticals, and metabolomics; and strengthening healthcare infrastructure in developing nations for efficient disease diagnosis and treatment are expected to propel the growth of this segment during the forecast periodBy application, the biomarker discovery segment accounted for the largest share of the metabolomics market.The biomarker discovery segment is expected to account for the largest market share in 2020.The use of metabolic biomarkers to assess the pathophysiological health status of patients is increasing.

In recent years, as a result of significant technological advancements, metabolomics has become a vital tool in discovering biomarkers. By Indication, Cancer segment expected to grow at the fastest growth rate during the forecast period.

Based on indication, the metabolomics market has been segmented into into cancer, cardiovascular disorders, neurological disorders, metabolic disorders, inborn errors of metabolism, and other indications (respiratory and infectious diseases.The cancer segment is expected to account for the largest market share in 2020, with the highest growth rate as well.

This can primarily be attributed to the increasing number of patients who have cancer and the subsequent increase in the demand for cancer therapies.

By End user, Academic and Research Institutes accounted for the largest share of the metabolomics marketThe academic and research institutes segment accounted for the largest share of the metabolomics market in 2020. The increasing number of research activities in the field of metabolomics and funding to the academic and research institutes to conduct metabolomics research are the factors responsible for the largest share of the segment.

Asia Pacific: The fastest-growing region in the metabolomics market.

The Asia Pacific market is projected to grow at the highest CAGR during the forecast period.Several global pharmaceutical firms have entered the APAC market to tap the significant growth opportunities in emerging Asian countries and lower their production costs by shifting their drug discovery R&D operations and manufacturing to the region.

A large number of qualified researchers and low-cost operations in APAC countries, such as India and China, are some of the major factors supporting this trend.

North America: The largest share of the metabolomics market.

North America, which includes the US and Canada, accounted for the largest share of the metabolomics market. The large share of the North America region can be attributed to the presence of major players operating in the metabolomics market in the US, growing biomedical research in the US, and rising preclinical activities by CROs and pharmaceutical companies in the region.

Breakdown of primariesThe study contains insights from various industry experts, ranging from component suppliers to Tier 1 companies and OEMs. The break-up of the primaries is as follows: By Respondent Supply Side- 80%, Demand Side-20% By Designation Executives- 25%, CXOs- 20%, Managers - 55% By Region North America - 50%, Europe - 20%, APAC 20%, RoW- 10%

The metabolomics market is dominated by a few globally established players such as Waters Corporation (US), Agilent Technologies (US), Shimadzu Corporation (Japan), Thermo Fisher Scientific (US), Danaher Corporation (US), Bruker Corporation (US), PerkinElmer (US), Merck KGaA (Germany), GE Healthcare (US), Hitachi High-Technologies Corporation (Japan), Human Metabolome Technologies, Inc. (Japan), LECO Corporation (US), Metabolon, Inc. (US), Bio-Rad Laboratories (US), Scion Instruments (US), DANI Instruments S.p.A. (Italy), GL Sciences (Japan), SRI Instruments (US), Kore Technology Ltd. (UK), and JASCO, Inc. (US)

Research Coverage:The report segments the metabolomics market based on region (North America, Asia Pacific, Europe, Latin America and Middle East & Africa), product & service (metabolomics instruments ((separation tools (((gas chromatography, high-performance liquid chromatography, ultra-performance liquid chromatography, and capillary electrophoresis))), detection tools (((nuclear magnetic resonance (NMR) spectroscopy, mass spectrometry (MS), and surface-based mass analysis))), bioinformatics tools and services) application (biomarker discovery, drug discovery, toxicology testing, nutrigenomics, functional genomics, personalized medicine, and other applications), indication (cancer, cardiovascular disorders, neurological disorders, metabolic disorders, inborn errors of metabolism, and other indications),end user(academic and research institutes, pharmaceutical & biotechnology companies, contract research organizations, and other end users).Company type (Tier 1, tier 2, Tier 3 providers of metabolomics instruments and services).

The report also provides a comprehensive review of market drivers, challenges, and opportunities in the metabolomics market.

Key Benefits of Buying the Report:The report will help the leaders/new entrants in this market with information on the closest approximations of the revenue numbers for the overall market and the sub-segments.This report will help stakeholders understand the competitive landscape and gain more insights to better position their businesses and plan suitable go-to-market strategies.

The report also helps stakeholders understand the pulse of the metabolomics market and provides them information on key market drivers, challenges, and opportunities.

Read the full report: https://www.reportlinker.com/p04763096/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The global metabolomics market size is projected to reach USD 4.1 billion by 2025 from USD 1.9 billion in 2020, at a CAGR of 13.4% - GlobeNewswire

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Robert Gallo of the UM School of Medicine Institute of Human Virology and Global Virus Network Awarded Top Life Sciences and Medicine Prize from China…

Monday, December 28th, 2020

BALTIMORE, Dec. 21, 2020 /PRNewswire/ --Robert C. Gallo, MD, The Homer & Martha Gudelsky Distinguished Professor in Medicine, co-founder and director of the Institute of Human Virology at the University of Maryland School of Medicine and co-founder and international scientific advisor of the Global Virus Network, was awarded the "VCANBIO Award for Biosciences and Medicine," a significant and authoritative award in the life sciences and medicine field of China. The elite Prize is jointly presented by the University of Chinese Academy of Sciences and the VCANBIO CELL & GENE ENGINEERING CORP, LTD to push forward scientific research, technological innovation and continuous development in the life sciences and medicine field of China.

"The Prize also serves to facilitate the industrial development and application of innovative life science achievements,"said George F. Gao, DVM, DPHIL (OXON), Director General of the Chinese Center for Disease Control and Prevention (China CDC), Director, CAS Key Laboratory of Pathogenic Microbiology and Immunology, Professor, Institute of Microbiology, Dean of the Medical School of the Chinese Academy of Sciences and Director of China's Global Virus Network Center of Excellence. "Dr. Gallo is a pioneer in virus research and most worthy of this Prize. We are pleased to see him recognized by many members of the Chinese Academy of Sciences."

"Hosted by the Medical School of the University of Chinese Academy of Sciences, this award commends outstanding and innovative Chinese and foreign scientists, who have accomplished innovation achievements and breakthroughs in the life sciences and medicine field,"said Yiming Shao, MD, the Chief Expert on AIDS, China CDC, Director of the Division of Research on Virology and Immunology, National Center for AIDS/STD Control and Prevention, China and Member of the GVN SARS-CoV-2 Task Force and China GVN. "I have worked with Dr. Gallo through the decades and admire his intellect and leadership, which have led to discoveries that have broad implications in protecting mankind from viral threats. I am delighted that my Chinese colleagues are recognizing him with this significant honor."

"Prof. Gallo has made a great deal of contribution to promote the Sino-American friendship and collaboration, especially for medical talent training and public health in China,"said Prof. Guanhua Xu, Chairman of the selection committee of the VCANBIO Award for Biosciences and Medicine.

"This is a tremendous and well-deserved honor for Dr. Gallo,"said E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, the John Z. and Akiko K. Bowers Distinguished Professor, and Dean, University of Maryland School of Medicine. "Dr. Gallo has dedicated his career to building international collaborations that have produced major scientific discoveries in human virology, including with leading scientists and academic colleagues in China. As a result, the Institute of Human Virology continues to be recognized as the global leader in the fight against chronic viral diseases."

"I am humbled and honored to receive this esteemed Prize from my colleagues in China,"said Dr. Robert Gallo. "I take this opportunity to stress that it is imperative that government and politics not interfere with science, and that my Chinese and American colleagues, who have a long history of collaborating together and contributing scientific breakthroughs to protect humanity from global health threats, continue to have the freedom to do so and to grow these collaborations."

A Distinguished Scientific Career Advancing Global Health

Dr. Robert Gallo has long believed in the necessity of international cooperation and collaboration in medical sciences in general, and infectious diseases in particular, in part to build global friendships and advance humanitarian principles. Though entertainment and sports facilitate such connections he believes the "knots" are tied best through medical sciences. Throughout his 30 years at the National Institutes of Health (NIH) and more recently his nearly 25 years at Baltimore's Institute of Human Virology (IHV) at the University of Maryland School of Medicine, he has fostered these connections. First, through his pioneering scientific discoveries including his discovery in 1976 of Interleukin-2, the first cytokine, a growth regulating substance now used as immune therapy in some cancers and in autoimmune diseases when suppressive T cells are needed. Then in 1980, the first human retrovirus, HTLV-1, a cause of human leukemia and paralytic neurological diseases as well as severe inflammatory disorders, which is endemic in some regions such as parts of Africa, the Caribbean Islands, Japan, Aboriginal Australians, Iran and South America. Dr. Gallo and his team developed a blood test for HTLV-1 applicable to all countries which protects people receiving blood transfusions that would be contaminated with this virus. Similarly, in 1984, when he and his team co-discovered HIV as the cause of AIDS they also developed the HIV blood test for the world and made their reagents available to all. Dr. Gallo and his team established collaborations in HIV/AIDS research, education, therapy and care for many African countries, particularly in Nigeria and some Caribbean nations. During the current pandemic he quickly became involved in initiating preventive measures against SARS-CoV-2 and COVID-19 disease through the idea of stimulating innate immunity with "live" virus vaccines such as the oral polio vaccine. Dr. Gallo, abetted by his collaborator, Konstantin Chumakov, PhD, Associate Director for Research for the U.S. Food and Drug Administration's (FDA) Office of Vaccines Research and Review and a GVN Center Director and his clinical colleague, Shyam Kottilil, MBBS, PhD, professor of medicine and director of the Clinical Care and Research Division of the Institute of Human Virology at the University of Maryland School of Medicine and senior advisor at the GVN, are advising on trials in India and in discussion about trials in Mexico, Brazil, Uzbekistan and China. He has also fostered the international nature of his research by hosting students beyond the U.S., including post-doctoral senior scientists from Asia, Middle East, Europe, the Americas and many African nations.

However, nothing demonstrates his concern for medical science cooperation more than when he established the idea for the Global Virus Network (GVN), which he co-founded in 2011 with the late Prof. Reinhard Kurth, MD, formerly Director of the Robert Koch Institute in Berlin, and Prof. William Hall, BSc, PhD, MD, DTMH, of University College Dublin. Now, GVN is headed by its President Christian Brchot, MD, PhD. The GVN was formed to advance medical and zoological science without any government influence, giving members of the GVN maximum freedom to speak freely while encouraging all nations to be involved. China, among several dozen other countries, has an active Center of Excellence within the GVN and was the site of the 7th meeting of the GVN in May 2015 held in Beijing and hosted by the late GVN Center Director, Zeng Yi of Beijing University of Technology. Experts shared information on varying viral threats, including those causing hemorrhagic fevers, hepatitis, HIV, measles, influenza, dengue and chikungunya, to name a few. GVN members also reviewed strategies at the center of the organization including the creation of specialized task forces and the launch of training programs to address growing viral threats.

A History with Chinese-American Collaborations

Dr. Gallo had a deep friendship with Dr. Robert Ting who came to the U.S. as a child refugee from Shanghai during the Japanese invasion. As a student, Dr. Ting worked with the famous Italian molecular biologist, Dr. Salvatore Luria at MIT, who won a Nobel Prize. Dr. Ting then went to Caltech to work with another Italian Nobel Prize winner, Dr. Renato Dulbecco and they were joined by two others who were soon to be Nobel Prize winners, Drs. Howard Temin and David Baltimore. Dr. Ting was not just Dr. Gallo's friend but also his teacher by introducing him to Chinese culture and food, tennis, and the field of virology. Soon after meeting Dr. Ting, another Chinese-born and educated young man, Dr. Alan Wu, came to Dr. Gallo's lab from Toronto bringing with him the knowledge and skills of blood stem cells. There were then several other Chinese post-doctoral fellows culminating with Dr. Flossie Wong-Staal from Canton Province and who played a very major role in advancing molecular biology on Dr. Gallo's team for about 15 years. Dr. Nancy Chang, also Chinese, came as a visiting scientist on a few occasions. On one such time she was key to the development of the second-generation HIV blood test used around the world.

In 2009, with the help of a University of Maryland School of Medicine colleague, Dr. Richard Zhao, born in China and educated in the U.S., the Shandong Academy of Medical Sciences (SAMS) announced the establishment of the Shandong Gallo Institute of Virology (SGIV). The announcement was made simultaneously with a ceremony to establish China's first Molecular Diagnostic Center for Personalized Healthcare (MDCPH), which was a joint venture among the University of Maryland, Baltimore, Roche Diagnostics Asia Pacific and SGIV at the Shandong Academy of Medical Sciences. The mission of the SGIV is to promote the basic science of virology especially in the area of HIV/AIDS and other important and emerging viral diseases and to facilitate translational research and clinical trials for related diseases. SGIV also aims to provide molecular-based testing for disease diagnosis, prognosis and treatment in the area of individualized molecular testing for personalized medicine.

Since the founding of the Institute of Human Virology (IHV), Dr. Gallo notes that several of his key science leaders at the Institute of Human Virology came from China, including: Dr. Wuyuan Lu (recent Director of the Division of Infectious Agents and Cancer), Dr. Yang Liu (recent Director of the Division of Immunotherapy), Dr. Pan Zheng (Division of Immunotherapy), Dr. Lishan Su (current Director of the Division of Virology, Pathogenesis and Cancer), Dr. Man Charurat (current Director of the Division of Epidemiology and Prevention and Ciheb) and Dr. Lai-Xi Wang (formerly at IHV and now at University of Maryland, College Park). With each of these leaders also came labs full of Chinese colleagues, who Dr. Gallo states contributed greatly to advancing America's biomedical research. Further, over the past six decades, Dr. Gallo visited China countless times to discuss potential collaborations with public and private sector entities, mentored rising Chinese scientists and facilitated open scientific discussions to advance the field of human virology, among other important things.

About the Institute of Human Virology

Formed in 1996 as a partnership between the State of Maryland, the City of Baltimore, the University System of Maryland, and the University of Maryland Medical System, the IHV is an institute of the University of Maryland School of Medicine and is home to some of the most globally-recognized and world-renowned experts in all of virology. The IHV combines the disciplines of basic research, epidemiology, and clinical research in a concerted effort to speed the discovery of diagnostics and therapeutics for a wide variety of chronic and deadly viral and immune disorders - most notably, HIV the virus that causes AIDS. For more information, visit http://www.ihv.org and follow us on Twitter @IHVmaryland.

About the Global Virus Network (GVN)

The Global Virus Network (GVN) is essential and critical in the preparedness, defense and first research response to emerging, exiting and unidentified viruses that pose a clear and present threat to public health, working in close coordination with established national and international institutions. It is a coalition comprised of eminent human and animal virologists from 59 Centers of Excellence and 11 Affiliates in 33 countries worldwide, working collaboratively to train the next generation, advance knowledge about how to identify and diagnose pandemic viruses, mitigate and control how such viruses spread and make us sick, as well as develop drugs, vaccines and treatments to combat them. No single institution in the world has expertise in all viral areas other than the GVN, which brings together the finest medical virologists to leverage their individual expertise and coalesce global teams of specialists on the scientific challenges, issues and problems posed by pandemic viruses. The GVN is a non-profit 501(c)(3) organization. For more information, please visit http://www.gvn.org. Follow us on Twitter @GlobalVirusNews

SOURCE Global Virus Network

gvn.org

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Robert Gallo of the UM School of Medicine Institute of Human Virology and Global Virus Network Awarded Top Life Sciences and Medicine Prize from China...

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Coagulo Medical Technologies Announces $6.5 Million in Financing to Accelerate Delivery of Disruptive Coagulation Diagnostics Platform – Business Wire

Monday, December 28th, 2020

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Coagulo Medical Technologies, an MIT-born startup that has developed the worlds first precision-medicine platform for comprehensive and targeted blood clotting management, today announced it has raised $6.5 million in financing from 20/20 HealthCare Partners, Sands Capital, Good Growth Capital, IAG Capital Partners and private investors. The Boston area diagnostics innovator also announced that it has been awarded a Small Business Innovation Research (SBIR) grant by the National Science Foundation to accelerate delivery of breakthrough innovations amid the global COVID19 public health crisis, which has called attention to the limitations of conventional coagulation tests.

Coagulos rapid, point-of-care device is a major advancement for personalized diagnosis and management of all coagulation-related diseases. The device is ultra-portable, requires just drops of blood and will provide vital, clinically-actionable information within 10 minutes. It leverages a proprietary and entirely novel approach to coagulation testing, which is capable of parsing through the entire coagulation cascade to pinpoint deficiency or inhibition of specific coagulation factors and quantifies their effect on clotting time.

Current coagulation testing methods were developed over a half-century ago, provide only general information on blood clotting function and cannot identify the specific cause of a clotting abnormality. Outdated testing technology is akin to a generic check engine light, whereas Coagulos test is designed to isolate the issue down to a specific diagnostic code. The device promises better health outcomes by permitting physicians to supplement clinical intuition with targeted information that they always wanted but no other technology could deliver, said Dr. Galit Frydman, CSO and President of the company. To be able to seamlessly deliver those comprehensive, sample-to-insight results using merely drops of blood, and to have that information within a clinically meaningful timeframe and at the bedside, will make Coagulos diagnostic platform a critical tool in meeting the ever-evolving challenges of coagulation management, added Jarrod Niebloom, Coagulos CEO and Chairman of the Board of Directors. No doubt the complex clotting issues that continue to be observed in patients with COVID19 epitomize just how antiquated existing diagnostic tools are and how pressing the clinical need is.

Coagulo has developed a platform that directly responds to current medical needs and, further, will support traditional tests like prothrombin time and activated partial thromboplastin time, said Hillel Bachrach, managing partner of 20/20 HealthCare Partners. We are excited to invest in Coagulo and to help accelerate their path to market as they up-end an industry that has seen very little innovation for decades.

20/20 HealthCare Partners, a global investment group based in Boston that invests at the early stage of technology and life science innovation, has led the investment.

About Coagulo:

Founded in 2018 and based out of Alexandria LaunchLabs, Coagulo licensed technology out of MIT and the Massachusetts General Hospital (MGH) developed by Dr. Galit Frydman, the companys CSO and President, who also holds appointments in the Division of Trauma, Emergency Surgery and Surgical Critical Care at MGH and in the Center for Biomedical Engineering at MIT. Coagulo has developed the next-generation of rapid, ultra-portable and comprehensive diagnostics for the personalized diagnosis and management of all coagulation-related diseases. Coagulos point-of-care device is not yet approved or cleared by the U.S. Food and Drug Administration for marketing in the United States.

http://www.coagulomed.com

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Coagulo Medical Technologies Announces $6.5 Million in Financing to Accelerate Delivery of Disruptive Coagulation Diagnostics Platform - Business Wire

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The Precision Medicine Market To Transcend The Covid-19 Barrier From 2024 Onwards – Farming Sector

Monday, December 28th, 2020

Market Report Summary

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The latest report published by Persistence Market Research titled Global Market Study on Precision Medicine: Drug Discovery Technology Segment Estimated to Witness 0.1% Decline in Market Share Between 2016 and 2024. projects some of the crucial aspects of the globalprecision medicine marketafter an in-depth research. The report assures that the market will grow manifold and it will register a 14.7% CAGR between 2016 and 2024.

Global Precision Medicine Market: The Propellers

The global expansion of the medicine industry will expand the canvas of the global precision market. Larger investments, better infrastructure, simplified approval process of drugs along with companion diagnostics will impact the structure of the entire climate of the global precision medicine market.

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The affordable DNA profiling, the bloating cancer population of the globe will create a favorable condition of growth for the global precision medicine market. The proper storage of genome data plays a crucial part in this segment. The emergence of data backed medicare will also drive the global precision market ahead.

But the market is combating acute data storage and data privacy issues and it also lacks in systematic approach towards funding and soaring prices of personalized drugs is also creating a blockade in the expansion of the global precision medicine market.

Global Precision Medicine Market: Market Autopsy

The global precision medicine market is bifurcated into multiple parent segments which are further sub-categorized. The primary division of the market is an assimilation of three, region, technology and application. The major technologies which will define the market character in the forthcoming years are bioinformatics, next-gen sequencing and drug discovery technology. The applications segment will showcase fruitful results and oncology will act as the showstopper.

The market prediction shows that this segment will bloom and will touch an approximate value of US$ 69 Bn by the end of the assessment period. The approximate registered CAGR of this segment within the assessed period will be above 13.5%. The global population is struggling with some of the acute diseases such as arthritis. A large slice of the aged population is an easy prey of this crippling ailment. The immunology segment will reap maximum benefits from the population affected by arthritis. The immunology segment will gain revenue from the market and the market worth will cross US$ 34 Mn by the end of 2024.

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Global Precision Medicine Market: Regional Scrutiny

The regional market arena has penetrated through different key regions of the globe. The global precision medicine market has extended its boundaries in the last few years. The product has a massive global presence and it is expanding steadily. Apart from North America, Europe, MEA, Latin America and Asia Pacific regions are other major pockets which are expected to show fruitful outcome in the forthcoming years.

The global precision medicine market is expected to perform well in the North American region and it will occupy more than 35% of the market share within the period of prediction. The global precision market in North America will flourish and will probably touch the approximate market value of more than US$ 60 Mn by 2024 end. With a stupendous performance the US and Canada will conquer a lion share of the global precision medicine market of this region predicts the report.

The Europe is a consistent market and will crawl up the revenue chart within the forecast period. The global precision market in Europe will ride an estimated CAGR of more than 13% to sew up an average worth of more than US$ 40 Mn by the end of 2024. In Europe the markets spread across Germany and France will shape the destiny of this market. Apart from this the countries such as Spain, UK and Italy will also follow the leading pack during the period of assessment.

The APAC region is the rising star of the global precision medicine market. The region will project a CAGR of more than 14% during the period of projection. The market will witness a staggering hike and will touch approximately US$ 35 Mn by the end of 2024. In the APAC region Japan will spearhead the market, China and India will lock horns to accumulate maximum market share during the projected period.

The region of Latin America will score considerable revenue during this period. MEA will be a sulking market as less of research activities will dampen the spirit of the precision medicine market.

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Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics and market research methodology to help businesses achieve optimal performance.

To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

Our client success stories feature a range of clients from Fortune 500 companies to fast-growing startups. PMRs collaborative environment is committed to building industry-specific solutions by transforming data from multiple streams into a strategic asset.

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The Top Five Hypergrowth Industries I’m Targeting In 2021 – Forbes

Monday, December 28th, 2020

dpa/picture alliance via Getty Images

Here are the top new hypergrowth industries Im focused on right now. My research shows all of them will soon have their breaking out moment in 2021:

1.Synthetic Biology

Synthetic biology is a brand-new sector where breakthrough technology allows scientists to program living things. Im sure youve seen the DNA double helix before.

Source: edn.com

DNA is basically your bodys unique set of instructions. Its what makes you, you. Your unique DNA makeup determines what you look like, how your body functions. Think of DNA as the source code of every living thing on Earth. Synthetic biology gives us the tools to edit and create the DNA of an organism to get it to do something entirely new. Basically, it allows scientists to alter the makeup of living things.

How does it work? In short, engineers design sequences of DNA on computers. Then they physically print out those sequences and insert them into living things. This can then add beneficial character traits to a living thing.

For example, scientists already use it to make self-fertilizing plants. Joyn Bio used fake DNA to modify the microbes of plants so they can pull nitrogen gas from the air and convert it into fertilizer. Using synthetic biology, scientists have also created a reliable source of artemisinin which is used in malaria vaccines.

Fake meat pioneer Beyond Meat also harnessed this new technology to create more realistic veggie burgers. It was first to use a DNA coding sequence from soybeans to create meat that looks and tastes like beef but is actually made from vegetables.

In short, this breakthrough tech allows scientists to reprogram the operating system of plants and other organisms. Synthetic biology is hands down the most cutting-edge industry on earth right now. Just as Intels microchips and IBMs computers underpinned Americas computing revolution,Twist BiosciencesDNA synthesis platform provides the building blocks for the biology revolution.

2.Genomics

DNA carries your genetic information. Think of it as a set of instructions for your body. Mapping your DNA allows scientists to decipher your bodys unique set of instructions. By learning the secrets hidden within your DNA, doctors can tell what diseases youre likely to get. This allows them to catch problems earlier and diagnose them more accurately.

In fact, the use of DNA mapping in healthcare is exploding right now. A new prenatal test based on DNA mapping can detect hard-to-find problems with babies inside their mothers wombs. Its the fastest-growing medical test in American history.

Invitae(NVTA)is using these breakthroughs to turn Americas healthcare system on its head. In short, its building an alternate healthcare industry around DNAor geneticinformation.

By the end of 2020, Invitae will have mapped the DNA of almost one million Americans. And its creating a system where this information is used in our healthcare decisions. For example, most cancers have a genetic link. In other words, mapping DNA can help detect the disease early. And when it comes to cancer, an accurate and timely diagnosis can literally save your life.

But right now, many cancers go largely undetected. Invitae is working to change this. I see genetic mapping ushering in the era of personalized medicine in America. If you havent heard about this yet, you will soon.

In short, DNA mapping will allow you, as an individual, to know which diseases youre most at risk for. Knowing this, youll better understand the perfect foods, the perfect drugs, and the perfect exercise regimen, just for you.

But thats only stage one. The genomics industry is evolving from mapping our DNA to editing it. Gene editing promises to transform how we treat and cure disease. Humans have between 20,000 and 25,000 genes that carry the DNA instructions for our bodies. But devastating diseases like cystic fibrosis and sickle cell anemia are caused by just one error.

Gene editing is making cures for certain diseases possible for the first time in history. It has the potential to cure thousands of diseases like cystic fibrosis, Huntingtons, sickle cell anemia, and hemophilia.

Space has always been a business dominated by governments. The Space Race between America and the Soviet Union kicked off back in the 1950s. And since then, the US government has pumped $600+ billion into NASA. That dwarfs the $20 billion that private companies have invested in space.

But over the past decade, theres been a quiet revolution in the space industry. The advent of reusable rockets and innovative launch methods have slashed the cost of going to space. The cost to launch a satellite into orbit has dropped more in the past 10 years than in the entire history of space!

Rapidly declining costs are transforming space travel into a thriving business. In fact, private space investment has jumped 400% since 2013. Elon Musks intergalactic company SpaceX has launched 20+ resupply rockets to the International Space Station over the past few years. And earlier this year SpaceX sent its first two astronauts into space on its Crew Dragon capsule. It was the first privately built rocket and capsule ever to put humans into space.

Amazon founder Jeff Bezos is also pushing private space exploration forward. His company, Blue Origin, recently won a NASA contract to put Americans back on the moon. In short, the era of private space exploration is here. Over the coming years, tourists will fly into outer space, companies will figure out how to mine asteroids, and companies likeMaxar Technologies (MAXR)will continue to improve their fleets of spy satellites.

Over the past decade, investors have poured a record $26 billion into 535 space companies globally. Last year alone $5.8 billion was investeda new record. In fact, data from the Space Foundation shows the space economy generated $415 billion in revenue last year. Current industry projections peg the 2040 global space economy at between $1 and $3 trillion.

And keep in mind, government activity in space is growing once again. The Commerce Department revitalized the Office of Space Commerce, which was established over 30 years ago to help enable commercial space activities. Last December, Congress approved a $738 billion defense policy bill to create a Space Force, the sixth branch of the US military.

The core idea of artificial intelligence (AI) is a machine that learns and thinks just like you or me. Most important, it learns all by itself, without human intervention. But please understand, AI isnt one single all-knowing machine like you see in the movies. Instead, it describes intelligent computers that do ultra-specific tasks.

For example, right now machines are learning to see for the first time ever. This is the basis of the flourishing computer vision industry. Medical imaging disruptor Paige is using computer vision to revolutionize the way we diagnose cancer. Paige fed millions of real-life medical images into its computer program and taught it to detect early signs of tumors.

And it recently tested the system by scanning 12,000 medical images for potential tumors. It had never seen these images before, yet achieved near-perfect accuracy. In other words, this computer has learned to recognize cancerous tumors better than human doctors. Paige is just one example of machines performing like superhuman doctors.

Stanford researchers recently built a computer that scans MRIs to detect Alzheimers disease with 94% accuracy. Other teams are teaching computers to drive. Amazon recently acquired top self-driving car startup Zoox for $1.2 billion. Zooxs computer on wheels is so good at driving it can zip through San Franciscos busy streets without a human driver.

Then you have firms developing checkout-free grocery stores, which turns your local Whole Foods into a giant supercomputer. Earlier this year, Amazon launched its Dash Cart. The shopping cart uses computer vision algorithms and sensors to identify the items in the cart. So you can simply grab items, throw them in the cart, and walk out.

In short, these are all world-changing technologies that will make many folks rich. Many new, unique disruptions are hiding underneath the misleading banner of AI.

Do you remember when every company had a dedicated payroll department?Now most businesses outsource it to companies like Paylocity and Paycom. In fact, offloading your payroll department makes total sense. Why do it yourself when you can pay a specialist to do it for less?

And as businesses outsourced their payroll needs, Paylocity and Paycoms stocks surged. This outsourcing phenomenon isnt just confined to payroll anymore. All kinds of functions that used to be done in-house like accounting, web design, IT support, and data storage are being offloaded now. For example, most companies that need to build a website no longer hire a whole web design team. Instead, they pay firms like Shopify and Wix to handle all their online needs.

Firms still employ armies of accountants to look after their finances. But this is rapidly changing. An upstart called BlackLine has created software that automates most accounts payable and receivable jobs. It now counts major firms like Nike, Costco, and Dominos as customers. And its stock has shot up 300%+ in the past couple years.

Remember when every office in America had a dedicated server room? The in-house IT department would look after the companys systems. And ensure hackers couldnt steal valuable data.

IT departments are now shrinking rapidly. Instead of employing dozens of workers to stop hackers, companies now simply pay cybersecurity firms likeOktaandZscalera monthly fee to protect their networks.

Then you have a company likeSmartsheet, which is automating much of what project managers used to do. Its app basically allows teams to collaborate, manage, and report on work in real time. And its stock has surged 150%+ over the past couple months.

All these jobs used to be done by in-house employees. Now they are being outsourced to specialist firms. And the firms pioneering new software products have been among the best-performing stocks in the entire market.

Get my report"The Great Disruptors:3 Breakthrough Stocks Set to Double Your Money".These stocks will hand you 100% gains as they disrupt whole industries.Get your free copy here.

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The Top Five Hypergrowth Industries I'm Targeting In 2021 - Forbes

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AI In Cancer Care: How It’s Making a Difference In Treatment And Care – Entrepreneur

Monday, December 28th, 2020

One of AI's key strengths is that it is able to process vast and complicated data in short amounts of time, and help automate routine tasks to reduce the level of human intervention needed

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December23, 20205 min read

Opinions expressed by Entrepreneur contributors are their own.

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Cancer incidence continues to grow worldwide. As per the latest figures from WHOs cancer database GLOBOCAN, 19.3 million new cases of cancer were reported in 2020.This figure is expected to rise to 27.5 million new cancer cases diagnosed each year by 2040. Thus, cancer will remain a key global health issue and utilize a significant chunk of our healthcare resources.

Many countries such as India face challenges in terms of limited healthcare resources available to treat the swelling number of cancer cases. The ratio of patients seeking care for cancer to the availability of cancer specialists is very high compared with developed countries. Indian oncologists, on average, treat a much larger number of cancer patients than their Western counterparts. The pathologist-patient ratio is also highly skewed, and hence the cancer care infrastructure in India faces enormous time pressure, with doctors having to examine a staggering amount of information to make treatment decisions, for every single cancer patient. The result is overcrowded health care facilities and long waiting periods in hospitals equipped to deal with cancer.

This is where artificial intelligence (AI) can be a game changer. One of AIs key strengths is that it is able to process vast and complicated data in short amounts of time, and help automate routine tasks to reduce the level of human intervention needed.

Application to image analysis allowing better screening and more efficient diagnosis

Early detection of cancer is the key to saving the lives of patients. A group at MIT developed a new deep learning-based prediction model that can forecast the development of breast cancer up to five years in advance. Their model was trained on mammograms and patient follow-up data to identify patterns that would not be obvious to or even observable by human clinicians. The results have so far shown to be far more precise, especially at predictive, pre-diagnosis discovery.

Wholeslide imaging is becoming routine in developed countries, which has resulted in the accumulation of digital pathology images and allowed the application of deep learning to pathological diagnosis. A deep learning convolutional neural network, or CNN, developed by a team from Germany, France and the US can diagnose skin cancer more accurately than dermatologists. In a recently reported study, the software was able to accurately detect cancer in 95 per cent of images of cancerous moles and benign spots, whereas a team of 58 dermatologists was accurate 87 per cent of the time.

Personalized medicine

By applying AI and machine learning to multiple data sourcesomics data, electronic health records, sensor/wearables data, environmental and lifestyle dataresearchers are taking first steps toward developing personalized treatments for diseases from cancer to depression. Here, AI is in action today and making great strides in cancer treatment by leveraging patient medical history and tumour characteristics to help generate multiple treatment options.

Various AI/ML models for breast cancer prognosis have successfully transitioned to clinical use. These models help accurately determine the risk of a patient suffering from a relapse, based on which treatment can be personalized. If a breast cancer patient has a low risk of relapse, then they could potentially avoid chemotherapy and all its side-effects. Other localized cancer treatments such as radiation are also increasingly relying on AI. Radiation oncologists are already using AI-driven software to create plans for personalized radiation therapy.

In the near future, AI/ML can mine large datasets (scans, blood work-up, patient follow-up from thousands of patients at one time) to detect early signs of patients who are responding to treatment, and those who are not.

Drug development

AL/ML can be applied in multiple stages of new drug discovery including designing the chemical/protein structure of drugs, target validation, investigating drug safety and managing clinical trials. The hope is that use of AI/ML in drug discovery will not only help significantly reduce thecost ofintroducing new drugs tothemarket, but also make the drug discovery process faster (currently 10-15 years including clinical trials) and more cost-effective (currently costs almost $1 billion per new drug). Companies today use deep learning software to sift through millions of possible molecules in a day or two, which would normally take months via traditional methods.

In conclusion, some AI solutions have already been deployed in clinical practice, but the industry has a long way to go.

In my opinion, AI should be seen as something that can help cancer specialists spend less time on routine tasks, reduce variability and human error rather than replace the specialists altogether. AI can sift through large data sets and aid in decision making rather than be a standalone tool for diagnosing or treating patients in a completely unsupervised environment. Also, we must ensure that the data going in to make the AI based algorithms must be of the highest quality/standards to ensure we get the most accurate algorithms in return.

With all the fears about AI making many jobs redundant, oncology could be a great example of how humans and technology can work together rather than against each other.

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Bayer and Tempus Initiate Collaboration to Advance Patient Access to Genomic Testing and Precision Medicine – Business Wire

Friday, December 11th, 2020

WHIPPANY, N.J. & CHICAGO--(BUSINESS WIRE)--Bayer and Tempus, leaders in precision medicine and artificial intelligence (AI), announced a new collaboration designed to provide broader access to genomic testing and tailored treatment approaches for the oncology community. The collaboration will include an initiative to help facilitate patient identification for precision oncology by providing testing, via the Tempus xT broad-panel genomic sequencing assay, for a subset of patients with metastatic colorectal cancer (mCRC), as well as those with radioactive iodine refractory differentiated metastatic thyroid carcinoma (RAIR thyroid cancers). Looking ahead, Bayer and Tempus will continue to implement data-enriched initiatives dedicated to supporting patients.

Bayer's commitment to precision oncology is currently supported by its approach to research that prioritizes targets and pathways that impact the way cancer is treated. The Tempus xT broad-panel genomic sequencing assay is designed to detect actionable driver alterations, including BRAF, KRAS, RET, and NTRK gene fusions.1 NTRK gene fusions are genomic alterations that drive tumor growth regardless of where they originate in the body.2-4 These genomic alterations typically occur following DNA damage, which results in structural changes to the DNA either through biological changes or from environmental factors (e.g. ultraviolet light damage).2-4 During the DNA damage repair mechanism, the NTRK gene can fuse with an unrelated gene resulting in an altered TRK fusion protein, which causes a constant signaling cascade, driving tumor growth and its metastasis (progression).2-4 Studies suggest NTRK gene fusions are present in approximately 3% of patients with mCRC with prior high microsatellite instability (MSI-H) status and 2.4%-12% of patients with RAIR thyroid cancers.5-7

Testing early and utilizing comprehensive genomic profiling is critical, as it helps physicians understand the underlying driver of DNA alterations for tumor progression (growth).8,9 When actionable alterations are detected, they aid physicians in the treatment decisions appropriate for their patients.10 The Tempus xT broad-panel genomic sequencing assay detects these alterations by sequencing tumor samples with matched normal saliva or blood samples, when available, covering 648 genes.1 The test is used by many oncologists across a diverse set of clinical settings, including leading academic centers, NCI designated cancer centers, hospital networks and community hospitals.

Bayers strong focus in precision medicine combined with Tempus unique testing offering has culminated in this collaboration to bring genomic testing to cancer patients, said Bhavesh Ashar, Senior Vice President, Head of U.S. Oncology at Bayer. "We are excited for the potential of this initiative to identify patients who may benefit from tailored treatment options.

"This strategic collaboration aims to provide eligible colorectal and thyroid cancer patients with broad based access to our genomic test to help their physicians make treatment decisions," said Ryan Fukushima, Chief Operating Officer of Tempus.

Healthcare professionals with eligible patients from the above tumor types can receive additional information by learning more at Tempus.com/bayerprogram and contacting Tempus at support@tempus.com.

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the companys approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to http://www.bayer.us.

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the worlds largest libraries of clinical and molecular data, and an operating system to make that data accessible and useful, Tempus enables physicians to make real-time, data-driven decisions to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

###

2020 Bayer

BAYER and the Bayer Cross are registered trademarks of Bayer.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayers public reports which are available on the Bayer website at http://www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

______________________________________________________________________________

References

PP-PF-ONC-US-1620-1

12/20

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Bayer and Tempus Initiate Collaboration to Advance Patient Access to Genomic Testing and Precision Medicine - Business Wire

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Increased Attention on Testing for Oncogenic Drivers in NSCLC Advances the Promise of Precision Medicine – Targeted Oncology

Friday, December 11th, 2020

Identification of key oncogenic drivers and the development of targeted therapies with clinical activity in patients harboring actionable mutations have revolutionized the treatment paradigm in nonsmall cell lung cancer (NSCLC), redirecting attention toward advances in biomarker testing methodologies. This new focus is poised to foster granular refinement of precise, targeted treatment of lung tumors.

Advances in NSCLC research have enabled an understanding of the disease as a collection of molecular subgroups. The proliferation of alteration-matched therapies specific to these subgroups is a prime example of a precision medicine approach. In addition to oncogenic driver mutations, therapeutic response biomarkers have been identified, such as PD-L1 expression as a predictor of immunotherapy efficacy.

Underscoring the importance of biomarker-guided treatment approaches, guidelines for molecular testing in NSCLC include an extensive list of alterations, such as sensitizing EGFR mutations and ALK gene fusions.1,2 The list continues to expand beyond these established canonical markers, with the addition of variants such as MET exon 14 skipping mutations and tumor mutational burden. In fact, the FDA recently approved therapies specific for tumors with these molecular characteristics.3,4

The rapid pace of biomarker discovery, characterization of molecular subtypes of NSCLC, development of matched targeted therapies, and regulatory approval of companion diagnostic tests has accelerated progress in the delivery of optimal care for patients with advanced NSCLC. Areas where continued optimization is particularly emphasized include determining which type of sample(s) should be tested, which biomarkers should be analyzed in different patient subsets, and which assays are most appropriate for specific (sets of) markers, as well as logistical and administrative factors, such as turnaround times and cost/reimbursement considerations.1,5,6

As biomarker testing in NSCLC evolves, investigators continue to evaluate testing approaches with the goal of standardizing the process of oncogenic driver identification.

At the 2020 Molecular Analysis for Precision Oncology (MAP) Virtual Congress, held October 9 to 10, 2020, presentations focused on recent developments in molecular testing, including the results of studies comparing testing methods for aberrations in the MET and NTRK genes.

MET Exon 14 Skipping

Gain-of-function alterations in MET, which encodes a receptor tyrosine kinase, drive oncogenesis. One such alteration with important implications for NSCLC is MET exon 14 skipping, resulting from several types of mutation in either exon 14 itself, the adjacent introns, or the flanking splice sites. Regardless, the effect is the same: a critical ubiquitination site is lost, which leads to MET protein accumulation and activation, enhancing MET pathway signal transduction and culminating in tumorigenesis. Previously, immunohistochemistry was typically performed to detect MET overexpression due to copy number changes. However, next-generation sequencing (NGS) is now the preferred testing method because it can also identify MET exon 14 skipping mutations, the primary driver of oncogenesis.7

MET exon 14 skipping mutations are actionable because the resultant protein is responsive to MET inhibition using tyrosine kinase inhibitors (TKIs) such as capmatinib (Tabrecta),7 which was approved in May 2020 for use in adult patients with metastatic NSCLC harboring a MET exon 14 skipping mutation.3 Compared with their sensitivity to specific TKIs, this subset of patients has exhibited lower rates of response to immunotherapy despite frequent tumor expression of PD-L1,8 suggesting a dual predictive role for the MET exon 14 skipping mutation as a biomarker.

In a study presented at MAP 2020, tumor samples from patients with NSCLC and no other driver mutations were tested for MET exon 14 skipping mutations over a period of 14 months. The investigators compared 2 DNA-based methods: NGS on the Ion Proton platform using AmpliSeq technology and fragment analysis using polymerase chain reaction (PCR) and size-based electrophoretic separation of the amplicons for detection of large deletions.9

Of the 87 patient samples tested, 13 were determined to have a MET exon 14 skipping alteration, with 5 harboring splice variants and 8 carrying deletions affecting the splice site. Two of these deletions were large, spanning 41 and 66 base pairs; they were detected by fragment analysis but not NGS. Although NGS is widely considered superior to single-gene assays, these data indicate that it may have limitations in detecting specific alterations and that complementary methods or large-coverage intron screening could be an alternative for optimal detection of MET alterations to inform selection of first-line treatment, according to lead study author Romain Loyaux, from the Molecular Oncology Department of Georges-Pompidou European HospitalAPHP in Paris, France.

Commenting on the failure of the NGS assay to detect large MET exon 14 deletions, Loyaux stated that fragment analysis is a cheap and robust method to detect large deletions, especially when no RNA is available (FIGURE).9-11 He noted that anchored, multiplex, targeted RNA-based NGS, like the technology developed by the Archer company, may be a good alternative when RNA is available; however, it has a 20% failure rate.12

NTRK Fusion Detection

Fusions involving the NTRK genes, which encode a family of receptor tyrosine kinases, result in a constitutively activated chimeric protein that promotes oncogenesis and therefore, can be therapeutically targeted with TKIs.7 Two FDA-approved TKIs, entrectinib (Rozlytrek) and larotrectinib (Vitrakvi), have activity in NTRK fusionpositive solid tumors.13,14

Broad, hybrid-capture DNA-based NGS, with RNA-based anchored multiplex PCR as an adjunct, are currently the primary methods of detecting NTRK gene fusions in patients with lung cancer.7 The availability of entrectinib and larotrectinib will likely foster further development of NTRK fusion detection methods for use in routine clinical practice.

A recent study presented at MAP 2020 evaluated the analytical performancenamely, sensitivity, specificity, and precisionof 3 commonly available RNA-based NGS assays. The assays examined were TruSight Oncology 500 (TSO500) by Illumina, Oncomine Focus Assay (OFA) by Thermo Fisher Scientific, and Fusion- Plex Lung (AFL) by Archer.15

The limits of sensitivity and precision were assessed using droplet digital PCR with admixtures of both NTRK fusionpositive and negative samples, whereas specificity was evaluated using NTRK fusionnegative clinical samples. The data showed that all 3 NGS assays successfully detected NTRK fusions; however, technical differences between the assays may impact their performance. For instance, although all tested assays demonstrated strong specificity, the sample metrics were variable. Quality control (QC) success rates for OFA and TSO500 were 83% and 77%, respectively, but only 43% of samples on AFL passed all assay QC metrics. Notably, the different assays missed specific NTRK fusions; OFA failed to detect NTRK1-LMNA, NTRK1-TFG, and NTRK2- PAN3, and TSO500 failed to report NTRK3-ETV6 (E5N14) and NTRK3-ETV6 (E5N15).15

Clinical Utility of NGS Panels of Different Sizes

It has been established that multigene panels are superior to single-gene assays for biomarker testing in NSCLC2; however, data to inform clinicians selection of specific NGS gene panels have been lacking.

In a recent study presented at MAP 2020, a literature review was conducted to compare 2 commercially available DNA-based NGS gene panels: the Ion AmpliSeq Cancer Hotspot Panel, covering hotspots in 50 genes (Panel 50); and the FoundationOne panel, covering the complete exons of 315 genes (Panel 315). The clinical utility of each panel was determined based on the number of detectable actionable alterations in various solid tumor types that it contained. The data showed a substantial gain in actionability using the larger gene panel, which matched more actionable genetic mutations to FDA-approved or experimental drugs; the number of actionable alterations in various solid tumor types using Panel 315 was a median 50% higher compared with Panel 50 (t test, P <.001). The authors attributed this gain to the inclusion of more genes related to homologous recombination repair deficiency and microsatellite instability/immunotherapy response in the larger panel.16

In the current era of precision medicine in lung cancer, defined histological subtyping, oncogenic driver testing, and analysis of tumor PD-L1 expression/immunotherapy sensitivity are crucial steps prior to therapeutic decision-making in NSCLC. As additional targeted agents are investigated in clinical trials and the incidence of their molecular targets are characterized in patient populations, expanded molecular testing may become necessary.

Molecular pathologists will continue to play an integral role in the continuum of care in NSCLC, from diagnosis to clinical decision-making based on biomarker detection. Molecular testing is likely to expand rapidly, and additional molecular subtypes will be identified that help match more patients with the optimal targeted therapies, providing highly personalized treatment plans.

Details of analytical procedures and assays will continue to be refined.17 By combining defined sets of biomarkers with appropriate protocols for collecting NSCLC samples and optimized methods for assessing specific changes, clinicians will be able to actualize the promise of precision medicine for patients with this challenging malignancy.

References:

1. Lindeman NI, Cagle PT, Aisner DL, et al. Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018;142(3):321-346. doi:10.5858/arpa.2017-0388-CP

2. NCCN. Clinical Practice Guidelines in Oncology. Non-small cell lung cancer, version 8.2020. Accessed October 26, 2020. https://bit.ly/2TKomAj

3. FDA grants accelerated approval to capmatinib for metastatic nonsmall cell lung cancer. FDA. May 6, 2020. Accessed November 2, 2020. https://bit.ly/360o7Xg

4. FDA approves pembrolizumab for adults and children with TMB-H solid tumors. FDA. June 16, 2020. Accessed November 2, 2020. https://bit.ly/2HWB64q

5. Smeltzer MP, Wynes MW, Lantuejoul S, et al. The International Association for the Study of Lung Cancer global survey on molecular testing in lung cancer. J Thorac Oncol. 2020;15(9):1434-1448. doi:10.1016/j.jtho.2020.05.002

6. Wempe MM, Stewart MD, Glass D, et al. A national assessment of diagnostic test use for patients with advanced NSCLC and factors influencing physician decision-making. Am Health Drug Benefits. 2020;13(3):110-119

7. Sabari JK, Santini F, Bergagnini I, Lai WV, Arbour KC, Drilon A. Changing the therapeutic landscape in non-small cell lung cancers: the evolution of comprehensive molecular profiling improves access to therapy. Curr Oncol Rep. 2017;19(4):24. doi:10.1007/s11912-017-0587-4

8. Sabari JK, Montecalvo J, Chen R, et al. PD-L1 expression and response to immunotherapy in patients with MET exon 14-altered non-small cell lung cancers (NSCLC). J Clin Oncol. 2017;35(suppl 15):8512. doi:10.1200/JCO.2017.35.15_suppl.8512

9. Loyaux R, Blons H, Garinet S, Urban P, Leger C, Bastide M. MET exon 14 screening strategy: how not to miss large deletions. Ann Oncol. 2020;31(suppl 5): S1217-S1239. doi:10.1016/j.annonc.2020.08.2163

10. Pruis MA, Geurts-Giele WRR, von der TJH, et al. Highly accurate DNAbased detection and treatment results of MET exon 14 skipping mutations in lung cancer. Lung Cancer. 2020;140:46-54. doi:10.1016/j.lungcan.2019.11.010

11. Davies KD, Lomboy A, Lawrence CA, et al. DNA-based versus RNAbased detection of MET exon 14 skipping events in lung cancer. J Thorac Oncol. 2019;14(4):737-741. doi:10.1016/j.jtho.2018.12.020

12. Cohen D, Hondelink LM, Solleveld-Westerink N, et al. Optimizing mutation and fusion detection in NSCLC by sequential DNA and RNA sequencing. J Thorac Oncol. 2020;15(6):1000-1014. doi:10.1016/j.jtho.2020.01.019

13. FDA approves entrectinib for NTRK solid tumors and ROS-1 NSCLC. FDA. Published August 15, 2019. Accessed October 28, 2020. https://bit.ly/3mPhUEB

14. FDA approves larotrectinib for solid tumors with NTRK gene fusions. FDA. Published November 26, 2018. Accessed October 28, 2020. https://bit.ly/381dXZe

15. Bormann Chung C, Lee J, Barritault M, et al. Evaluating targeted next-generation sequencing (NGS) assays and reference materials for NTRK fusion detection. Ann Oncol. 2020;31(suppl 5):S1221. doi:10.1016/j.annonc.2020.08.2172

16. zdemir B, Charrier M, Gerard CL, et al. Comparison of the clinical utility of two different size next generation sequencing (NGS) gene panels for solid tumours. Ann Oncol. 2020;31(suppl 5):S1219. doi:10.1016/j.annonc.2020.08.2166

17. Pennell NA, Arcila ME, Gandara DR, West H. Biomarker testing for patients with advanced non-small cell lung cancer: real-world issues and tough choices. Am Soc Clin Oncol Educ Book. 2019;39:531-542. doi:10.1200/EDBK_237863

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New Study Provides Personalized Breast Cancer Risk Information for Women with ATM Gene Mutations – GlobeNewswire

Friday, December 11th, 2020

Figure 1

Remaining Lifetime Risk for ATM PV Carriers

SALT LAKE CITY, Dec. 11, 2020 (GLOBE NEWSWIRE) -- In a spotlight poster discussion at the 2020 San Antonio Breast Cancer Symposium (SABCS), Myriad Genetics (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, today presented a new study that shows how its myRisk Hereditary Cancer and riskScore tests can better inform individualized clinical screening and prevention strategies for women at risk of developing breast cancer. The new Myriad study highlights how riskScore, a proprietary tool used to evaluate a womans risk of developing breast cancer, can accurately provide breast cancer risk information into a personalized assessment model for women carrying a pathogenic variant (PV) in the ATM gene.

This new study will enable a highly personalized risk calculation for patients who carry mutations in the ATM gene, said Nicole Lambert, president of Myriad Genetic Laboratories. As a result, women carrying gene mutations will be able to make more informed choices about how to manage their risk; if increased surveillance is sufficient or if they would consider surgical options.

Myriads riskScore test combines data from 20 years of genome-wide association studies with a validated algorithm that uses personal and family history. riskScore is performed in conjunction with Myriads myRisk Hereditary Cancer test, where myRisk identifies people who carry specific cancer-linked genetic mutations.

Asummary of the study is below. Follow Myriad on Twitter via @myriadgenetics and keep up to date with SABCS meeting news and updates by using the #SACBS20 hashtag.

riskScore Poster at SABCS Title: Development of a breast cancer risk assessment model for ATM mutation carriers incorporating Tyrer-Cuzick and a polygenic risk score Program Number: PD10-09 Session Title: Spotlight Poster Discussion 10 This study highlights the development of a comprehensive breast cancer risk model for ATM PV carriers incorporating an 86-variant PRS, along with family history and clinical information captured by Tyrer-Cuzick (a tool used to calculate the risk of breast cancer). The study found that with ATM PV carriers (N=216), a comprehensive model allowed for differentiation of carriers into low, moderate, and high breast cancer risk categories (See figure 1 below).

To view Figure 1. Remaining Lifetime Risk for ATM PV Carriers, please visit the following link:https://www.globenewswire.com/NewsRoom/AttachmentNg/d77da35a-714a-41f4-8a8a-dd79a79dc644

AboutriskScore riskScore is a clinically validated personalized medicine tool that enhances Myriads myRisk Hereditary Cancer test. riskScore helps to further predict a womens lifetime risk of developing breast cancer using clinical risk factors and genetic markers throughout the genome. The test incorporates data from more than 80 single nucleotide polymorphisms identified through 20 years of genome wide association studies in breast cancer and was prospectively validated in our laboratory to predict breast cancer risk in women of European descent. This data is then combined with a personal history and family history algorithm, the Tyrer-Cuzick model, to provide an individualized breast cancer risk assessment. Myriad is committed to advancing the validation of risk-assessment tools and making them available to all women, regardless of ancestry.

About Myriad myRisk Hereditary Cancer The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 35 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.

About Myriad Genetics Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website:www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor Statement This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the Company building ATM status into a clinically validated risk assessment tool that will create a more comprehensive, highly personalized report for patients seeking to understand their risk of developing breast cancer; and the Companys strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Intl, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2020, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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New Study Provides Personalized Breast Cancer Risk Information for Women with ATM Gene Mutations - GlobeNewswire

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Cellworks Personalized Biosimulation Clinical Trial Predicted ATO and ATRA Therapy Response in APL Patients with 93% Accuracy – GlobeNewswire

Friday, December 11th, 2020

SOUTH SAN FRANCISCO, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, today announced results from the myCare-021-01 clinical trial, which found that the Cellworks Omics Biology Model (CBM) predicted response to Arsenic Trioxide (ATO) and All-trans-retinoic Acid (ATRA) in Acute Promyelocytic Leukemia (APL) patients harboring PML-RARA fusions with 93% accuracy. The study also demonstrated that Cellworks CBM can identify new mechanisms of resistance in APL patients and suggest alternative regimens for non-responders by targeting patient-specific disease biomarkers unique to each.

Results from the myCare-021-01 clinical study will be featured as Oral and Poster Abstract #2784 on Monday, December 7, 2020 during the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition and published online at Blood.

The vast majority (99%) of APL patients have the PML-RARAfusion gene, which is the most critical event involved in the pathogenesis of APL. (Source: PMID: 32182684). The PML-RARAfusion confers a selective sensitivity to the targeted drugs, ATO and ATRA, with response rates over 90% (Source: PMID: 31635329). However, the mechanism of resistance in the minority of APL non-responders is not well understood. This study used the Cellworks Omics Biology Model (CBM) to predict response to the combination of ATO-ATRA in patients harboring the PML-RARA fusion and identify mechanisms of resistance.

The ability of Cellworks CBM to accurately predict non-response to ATO and ATRA in APL patients with PML-RARA fusion up-front could prevent ineffective treatments, avoid unnecessary adverse events and reduce treatment costs, said Dr. Scott Howard, MD, MSc, Professor at University of Tennessee Health Science Center. In addition, we need an understanding of the mechanism of resistance in APL non-responders to prescribe more efficacious therapies and improve patient outcomes. In this study, the Cellworks CBM identified clinically relevant deletions to genes in patients who did not respond to ATO and ATRA and suggested alternative therapies. By taking this personalized approach to treating cancer patients, we can move the needle closer to the ideal 100% response rate.

myCare-021-01 Clinical Study

In this study, outcomes of 30 APL patients treated with ATRA or ATRA plus ATO were compared with outcomes predicted by Cellworks CBM. Genomic data from 6 publications derived from whole exome sequencing (WES), targeted next-generation sequencing (NGS), copy number variation (CNV) and/or karyotype data were used. All data was anonymized, de-identified and exempt from IRB review.

The available genomic data for each profile was entered into the Cellworks CBM which generates a patient-specific disease protein network model using PubMed and other online resources. The CBM predicts the patient-specific biomarker and phenotype response of a personalized diseased cell to drug agents, radiation and cell signaling. Disease biomarkers that are unique to each patient were identified within the protein network models.

ATO and ATRA were simulated on all 30 patient cases. The treatment impact was assessed by quantitatively measuring the drugs effect on a cell growth score which is a composite of the quantified values for cell proliferation, survival, and apoptosis, along with the simulated impact on each patient-specific disease biomarker score. Each patient-specific model was also digitally screened to identify response to ATO and ATRA.

Results of the study demonstrated that Cellworks CBM correctly predicted the response to ATO and ATRA in 28 of 30 cases. The overall prediction accuracy was 93% with a PPV of 100%, NPV of 60%, sensitivity of 93%, and specificity of 100%. In 2 of 30 patients who did not respond to ATO and ATRA, the CBM identified clinically relevant deletions to EZH2, KMT2E, and HIPK2 genes. All three genes are located on chromosome 7 and these non-responders had monosomy 7.

About Cellworks Group

Cellworks Group, Inc. is a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology. Using innovative multi-omics modeling, computational biosimulation and Artificial Intelligence heuristics, Cellworks predicts the most efficacious therapies for patients. The Cellworks unique biosimulation platform is a unified representation of biological knowledge curated from heterogeneous datasets and applied to finding cures. Backed by UnitedHealth Group, Sequoia Capital, Agilent and Artiman, Cellworks has the worlds strongest trans-disciplinary team of molecular biologists, cellular pathway modelers and software technologists working toward a common goal attacking serious diseases to improve the lives of patients. The company is based in South San Francisco, California and has a research and development facility in Bangalore, India. For more information, visit http://www.cellworks.life and follow us on Twitter @cellworkslife.

All trademarks and registered trademarks in this document are the properties of their respective owners.

Media Contacts:

Barbara ReichertReichert Communications, LLCBarbara@reichertcom.com415-225-2991

Michele Macpherson, Chief Business OfficerCellworks Group, Inc.michele.macpherson@cellworksgroup.com

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Cellworks Personalized Biosimulation Clinical Trial Predicted ATO and ATRA Therapy Response in APL Patients with 93% Accuracy - GlobeNewswire

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Pennington Biomedical to select 375 participants for 2021 research study regarding benefits of exercise – WBRZ

Friday, December 11th, 2020

Engaging in regular exercise is typically viewed as a positive activity that results in improved physical and mental health.

But, does regular exercise affect some people more positively than others? And if so, why?

These are questions researchers at Pennington Biomedical Research Center feel compelled to investigate.

So far, they've developed a theory that a person's response to exercise is a direct result of their mitochondria, which are the subcellular structures that help our body by converting sugar into energy.

Armed with their theory, its related questions, and a new $2.5 million award from the National Institutes of Healths National Institute on Aging, Pennington's researchers will investigate the matter by way of a four-year study that will require the assistance of 375 participants.

Dr. Owen Carmichael, Ph.D., Professor and Director of Biomedical Imaging at Pennington Biomedical explained that the four-year study will compare mitochondria responses between younger and older adults who undergo exercise training.

He also expects to identify molecular factors that promote or discourage a positive mitochondrial change in addition to shedding lighton several theories, including that:

-Exercise will not improve mitochondrial function for a certain portion of the population.

-Age will not limit the mitochondrial response to exercise.

-Aerobic training will provide more mitochondrial capacity improvements than resistance training, regardless of age.

Pennington Biomedical Executive Director John Kirwan, Ph.D., said a better understanding of the biology behind the benefits of exercise will advance personalized medicine.

In the long term, we believe the studys findings will help physicians use each individual's unique biological characteristics to precisely tailor exercise training for that person.

In effect, physicians will be able to prescribe an exercise regimen that maximizes the health benefits for each individual patient, Dr. Kirwan said.

As previously mentioned, the study will involve around 375 participants, and Pennington Biomedical plans to begin recruiting volunteers in the Spring of 2021.

Interested individuals should visit http://www.pbrc.edu/clinical-trials/#studylistfor updates.

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