StemCell Therapy

Dublin, July 15, 2022 (GLOBE NEWSWIRE) -- The "Global Microtome Market (2022-2027) by Product, Application, End User, Geography, Competitive Analysis, and the Impact of Covid-19 with Ansoff Analysis" report has been added to ResearchAndMarkets.com's offering.

The Global Microtome Market is estimated to be USD 449 Bn in 2022 and is projected to reach USD 596.34 Bn by 2027, growing at a CAGR of 5.84%.

Market Dynamics

Market dynamics are forces that impact the prices and behaviors of the Global Microtome Market stakeholders. These forces create pricing signals which result from the changes in the supply and demand curves for a given product or service. Forces of Market Dynamics may be related to macro-economic and micro-economic factors. There are dynamic market forces other than price, demand, and supply. Human emotions can also drive decisions, influence the market, and create price signals.

As the market dynamics impact the supply and demand curves, decision-makers aim to determine the best way to use various financial tools to stem various strategies for speeding the growth and reducing the risks.

Market Segmentations

The Global Microtome Market is segmented based on Product, Application, End Userand Geography.

Company Profiles

The report provides a detailed analysis of the competitors in the market. It covers the financial performance analysis for the publicly listed companies in the market. The report also offers detailed information on the companies' recent development and competitive scenario. Some of the companies covered in this report are AGD Biomedicals, Amos Scientific, Boeckeler Instruments, Bright Instruments, etc.

Countries Studied

Competitive Quadrant

The report includes Competitive Quadrant, a proprietary tool to analyze and evaluate the position of companies based on their Industry Position score and Market Performance score. The tool uses various factors for categorizing the players into four categories. Some of these factors considered for analysis are financial performance over the last 3 years, growth strategies, innovation score, new product launches, investments, growth in market share, etc.

Ansoff Analysis

Why buy this report?

Key Topics Covered:

1 Report Description

2 Research Methodology

3 Executive Summary

4 Market Dynamics4.1 Drivers4.1.1 Increasing Consumer Awareness of Early Disease Diagnosis 4.1.2 Growth in Incidence of Chronic Diseases such as Cancer 4.1.3 Increasing Geriatric Population Coupled with Increasing Healthcare Expenditure4.2 Restraints4.2.1 Lack of Skilled Expertise and Unfavorable Reimbursement Policies4.3 Opportunities4.3.1 Increasing Demand for Personalized Medicine 4.3.2 Emerging Introduction of Technologically Advanced Diagnostic Equipment and Pathological Systems4.4 Challenges4.4.1 Reduced Adoption Rate in Under-developed and Developing Economies

5 Market Analysis5.1 Regulatory Scenario5.2 Porter's Five Forces Analysis5.3 Impact of COVID-195.4 Ansoff Matrix Analysis

6 Global Microtome Market, By Product6.1 Introduction6.2 Microtome Instruments 6.2.1 Rotary Microtomes 6.2.2 Cryostat Microtomes 6.2.3 Vibrating Microtomes 6.2.4 Other Microtomes 6.3 Microtome Accessories 6.3.1 Microtome Blades 6.3.2 Other Microtome Accessories 6.4 Technology 6.5 Manual Microtomes 6.6 Semi-Automated Microtomes 6.7 Fully Automated Microtomes

7 Global Microtome Market, By Application7.1 Introduction7.2 Disease Diagnosis 7.3 Medical Research

8 Global Microtome Market, By End User8.1 Introduction8.2 Hospital Laboratories 8.3 Clinical Laboratories 8.4 Other End Users

9 Americas' Microtome Market9.1 Introduction9.2 Argentina9.3 Brazil9.4 Canada9.5 Chile9.6 Colombia9.7 Mexico9.8 Peru9.9 United States9.10 Rest of Americas

10 Europe's Microtome Market10.1 Introduction10.2 Austria10.3 Belgium10.4 Denmark10.5 Finland10.6 France10.7 Germany10.8 Italy10.9 Netherlands10.10 Norway10.11 Poland10.12 Russia10.13 Spain10.14 Sweden10.15 Switzerland10.16 United Kingdom10.17 Rest of Europe

11 Middle East and Africa's Microtome Market11.1 Introduction11.2 Egypt11.3 Israel11.4 Qatar11.5 Saudi Arabia11.6 South Africa11.7 United Arab Emirates11.8 Rest of MEA

12 APAC's Microtome Market12.1 Introduction12.2 Australia12.3 Bangladesh12.4 China12.5 India12.6 Indonesia12.7 Japan12.8 Malaysia12.9 Philippines12.10 Singapore12.11 South Korea12.12 Sri Lanka12.13 Thailand12.14 Taiwan12.15 Rest of Asia-Pacific

13 Competitive Landscape13.1 Competitive Quadrant13.2 Market Share Analysis13.3 Strategic Initiatives13.3.1 M&A and Investments13.3.2 Partnerships and Collaborations13.3.3 Product Developments and Improvements

14 Company Profiles14.1 AGD Biomedicals 14.2 Amos Scientific14.3 Boeckeler Instruments14.4 Bright Instruments14.5 Campden Instruments 14.6 Cardinal Health14.7 Danaher 14.8 Diapath 14.9 Histo-Line Laboratories14.10 Jinhua YIDI Medical Appliance14.11 Laboid International14.12 Lafayette Instrument 14.13 Medimeas14.14 Medite Medical14.15 Microtec Laborgerate14.16 Milestone Medical14.17 RWD Life Science14.18 Sakura Finetek 14.19 Shenzhen Dakewei Biotechnology14.20 SLEE Medical14.21 SM Scientific Instruments14.22 Ted Pella

15 Appendix

For more information about this report visit https://www.researchandmarkets.com/r/4xhy15

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Outlook on the Microtome Global Market to 2027 - Increasing Demand for Personalized Medicine Presents Opp - Benzinga

In February, UCI launched the Institute for Precision Health, a campus-wide, interdisciplinary endeavor that merges UCIs powerhouse health sciences, engineering, machine learning, artificial intelligence, clinical genomics and data science capabilities. The objective is to identify, create and deliver the most effective health and wellness strategy for each individual person and, in doing so, confront the linked challenges of health equity and the high cost of care.

IPH will bring a multifaceted, integrated approach to what many call the next great advancement in healthcare. The institute is an ecosystem for collaboration across disciplines that comprises seven areas. Along with co-directing the institute, Leslie Thompson Donald Bren and Chancellors Professor in psychiatry & human behavior and neurobiology & behavior co-leads the precision omics section, which generates and translatesgenomic, proteomic and metabolomic research results into clinical applications.

Thompson is among the earliest trailblazers in pursuing personalized treatment strategies for neurodegenerative diseases. Under her co-direction, IPH pushes for understanding the mechanisms for neurodegenerative and other diseases for which there are currently no treatments available. A long-time Anteater, Thompson earned her masters and Ph.D. from UCI.

Why is the Institute for Precision Health so important to you?

So far, precision medicine approaches have mostly commonly been used to treat cancer. Clinicians can utilize data-driven approaches to determine whether a given drug would be expected to work in a specific individual. Ive dedicated my career to studying neurodegenerative diseases like Huntingtons and ALS. With so many of these diseases, including the more common Alzheimers and Parkinsons disease, there is no treatment available that changes the course of the disease, and so many clinical trials have failed to show benefit to patients. Many researchers think the reason there is so little by way of treatment is because we havent been able to fully understand the diseases in individuals that there is not a one-size-fits-all in disease treatment. We need to have ways of understanding diseases in subgroups of patients that incorporates their genetics, environment and other factors that influence health so that we can define diseases better, understand them better and hopefully treat them better. Thats one aspect of IPH that really motivates me.

The capabilities of Institute for Precision Health might allow for better treatments?

Yes. And more. With the resources of IPH, what we can do has broadened significantly. So not only can we use data to understand these diseases and subgroups of patients better, but we can also develop and use state-of-the art analytic tools such as machine learning and artificial intelligence to distinguish individual disease features and or predict the course of disease. The capabilities of IPH through efforts of clinicians who use AI have enabled establishing a scoring system to inform which COVID-19 patients would be predicted to lead to more severe disease and thus greater medical intervention and optimized patient treatment. A critical aspect of healthcare is to understand the needs of the community as well, which is a major component of IPH. A goal is to utilize the infrastructure being developed through IPH to help clinical trials happen much more rapidly with the right cohort of patients, have new ways to evaluate effectiveness of treatments, engage communities and move into a realm of greater partnership with patients and their communities.

The capacity of UCIs Collaboratory the data center of IPH is key?

Yes. It is extremely challenging to put the various forms of data and information for, say, a given person or a given disease together in one place one platform so that researchers, clinicians and other partners can access and work with the data. With UCIs Collaboratory and our platform provider Syntropy, we can gather not only the de-identified health information that is in the medical record but also relevant genomic or other clinical or research data. The goal is to provide broad benefit to UCI and broad engagement across campus. And really beyond the campus.

Does this feel a little like the launch of the first smart phone, where in the beginning we marveled at the cool features and then, almost immediately, we couldnt imagine life without it?

I think so. And, you know, we had so many of the components here at UCI that have been brought together AI tools being developed across campus and the ability to carry out genomics and other omics, and then the efforts of the Collaboratory and the platforms that can house data. But while components were there, they hadnt yet been integrated into that smart phone, so to speak. Now were putting the components together and continually improving capabilities. Our vision is to provide a systematic approach to accomplish things we have never been able to do previously. Even seemingly small things like, how do you track one patient without any identifiers and all the information thats relevant to that patient and their disease? And so much more.

Youve been a part of groundbreaking research and have had so many professional accomplishments. How exciting is IPH in comparison to what youve already done?

Ive been involved in many very meaningful research projects in my career, but to be perfectly honest, this is huge for me, as I feel it ultimately can help the families that I so passionately care about. I see this as my whole career in human genetics and studying human disease has led up to IPH.

The vision is right, the opportunity is here, and UCIs leadership is so supportive of IPH. There is a growing excitement that, yes, we can do something transformative. So, I hope for big things to come out of IPH. Yes, Im all in.

You mentioned that you believe the work IPH does will benefit people beyond the campus. Can you talk a little bit about that?

I think well see further relationships with industry, with community groups, with other research institutions and clinical entities and most importantly with the patients themselves. We are building something that increases our ability to use and integrate data, and that will be useful to so many people and will enable greater health equity.

Do you have any sort of success timeline in mind?

I think most researchers hesitate to think that way because there have been diseases many of us thought wed have a cure for in 10 years, and 30 years later there isnt even an effective treatment. But, that said, I do think that the great thing with this is that many of the components have already been initiated and are working and we have incredible opportunities to now integrate efforts and diverse sets of data to inform patient health and disease. Im confident that there will be immediate goals that IPH will achieve throughout the next year or two. Then there are longer goals that will take five years or 10 years. And even longer-range goals that will be refined as we go.

Do you believe that even in a year or two patients who get care through UCI will feel the effects of IPH?

Yes, absolutely. Patients are already impacted because of IPHs work with COVID-19. One project involving genomics is to try and pinpoint the diagnosis for patients with a muscle weakness disorder that has defied genetic diagnosis. During this next year, well see if we can find genetic causes of that disorder. And through efforts of the AI groups, there will be development of algorithms to assess effectiveness of tools or treatments recently deployed in the hospital. Those are just a couple examples.

Do you see a day where many diseases are diagnosed quicker and more accurately?

Thats certainly one of our goals. IPH researchers have already developed an AI tool to diagnose stroke much more quickly compared to more standard methods. I suspect IPH will be working on many more tools that function in similar ways.

What does UCI bring to the table that maybe some other institutions dont?

One big strength is the support from Chancellor Howard Gillman and other campus leaders. [Vice Chancellor of Health Affairs] Steve Goldstein has led the charge for this institute to become a reality. Also, the fact that we have so much AI, machine learning and artificial intelligence expertise across UCI along with many acclaimed clinicians and medical researchers. Having an academic medical center certainly presents opportunities that researchers elsewhere might not have where they may have great AI expertise but without a medical center. We also perhaps have a unique focus health equity with existing relationships with the community. So, we are distinctive in the fact that we have all the pieces here. UCI is also a uniquely collaborative and nimble institution. We come together and make things happen quickly at UCI. Thats a characteristic of this university that Ive seen play out during my whole career here.

Will there be opportunities to study Orange County to see, as a community, what kind of impact IPH has?

IPH is engaged in this already, and it is a major goal moving forward.

And the way youre able to use data is special?

Yes. Quite often researchers have pulled information from the medical records that is structured data, that has an important role in research that has been facilitated at UCI through efforts of the Collaboratory. However, one of the things that is unusual about the platform is that there will be ways to capture all the structured and unstructured data. This is a big deal.

Everything needs funding, though. Whats happening in that regard?

Yes, great question. Certainly, one of the biggest challenges for any endeavor is raising money. Through support by UCI, we have the funds to launch IPH efforts, but there will need to be extensive fundraising and plenty of grant writing. Philanthropy will be integral to our success and visionaries to relay the excitement about our mission.

If you want to learn more about supporting this or other activities at UCI, please visit the Brilliant Future website athttps://brilliantfuture.uci.edu. Publicly launched on October 4, 2019, the Brilliant Future campaign aims to raise awareness and support for UCI. By engaging 75,000 alumni and garnering $2 billion in philanthropic investment, UCI seeks to reach new heights of excellence instudent success,health and wellness, research and more. UCI Health Affairs plays a vital role in the success of the campaign. Learn more by visitinghttps://brilliantfuture.uci.edu/uci-health-affairs/.

About UCI Institute for Precision Health: Founded in February 2022, the Institute for Precision Health (IPH) is a multifaceted, integrated ecosystem for collaboration that maximizes the collective knowledge of patient data sets and the power of computer algorithms, predictive modeling and AI. IPH marries UCIs powerhouse health sciences, engineering, machine learning, artificial intelligence, clinical genomics and data science capabilities to deliver the most effective health and wellness strategy for each individual person and, in doing so, confronts the linked challenges of health equity and the high cost of care. IPH is part of UCI Health Affairs, and is co-directed by Tom Andriola, vice chancellor for information, technology and data, and Leslie Thompson, Donald Bren Professor of psychiatry & human behavior and neurobiology & behavior. IPH is a comprised of seven areas: SMART(statistics, machine learning-artificial intelligence), A2IR(applied artificial intelligence research), A3(applied analytics and artificial intelligence), Precision Omics(fosters translation of genomic, proteomic, and metabolomic research findings into clinical applications), Collaboratory for Health & Wellness(providestheecosystem that fosters collaboration across disciplines through the integration of health-related data sources), Deployable Equity(engagescommunity stakeholders and health-equitygroupsto create solutionsthat narrow the disparities gap in the health and wellbeing of underserved and at-risk populations.) and Education and Training (brings data-centric education to students and healthcare practitioners so they can practice at the top of their licenses).

Originally posted here:
Precision health perspectives - UCI News

Strategic partnership leveraging FidoCure's precision medicine platform advances joint vision for providing personalized, accessible veterinary cancer care

AUSTIN, Texas and PALO ALTO, Calif. (PRWEB) July 15, 2022

Thrive Pet Healthcare, a national veterinary hospital network, and https://www.fidocure.com/FidoCure, the leading pet precision health company, today announced a strategic partnership to provide personalized, accessible veterinary cancer care. Thrive Pet Healthcare's nationwide network of over 350 veterinary care clinics will now have access to FidoCure's cutting edge precision medicine platform and unparalleled algorithmic driven diagnostics. By joining forces, these two patient centric companies are poised to deliver groundbreaking pet specialty cancer care at scale and help improve outcomes in pets with cancer.

With roughly six million new cancer diagnoses in dogs each year, approximately one in three dogs will develop cancer during their lifetime. The FidoCure precision medicine platform, developed to address the vast unmet need for better canine cancer care, uses genomic-guided DNA testing to identify genetic mutations that can cause cancer in dogs and matches them to individualized treatment with targeted therapies.

"We are thrilled to partner with FidoCure to offer ground-breaking precision cancer treatment to pet patients in our communities," said Thrive's Chief Medical Officer, Dr. Scott Schatzberg. "Through this powerful partnership, we reinforce our belief in nurturing the animal-human bond and providing exceptional pet healthcare at every stage of a pet's life. Every cancer case is unique, and now a personalized course of treatment is available to every patient within our nationwide network so that they can thrive."

Approximately 3,000 dogs diagnosed with cancer have used the FidoCure Next Generation DNA Sequencing Test, resulting in the largest proprietary canine cancer dataset in the world. Sharing outcomes data, an additional element of this partnership, will significantly expand this dataset. Since humans and dogs are both vulnerable to similar genetic mutations that may cause cancer, the growth of this dataset may help not only advance canine oncology research, but research for humans as well.

"We are delighted to be collaborating with one of the world's most trusted, innovative, and connected pet healthcare networks. This partnership between FidoCure and Thrive Pet Healthcare means that more pet parents, working with Thrive's leading specialty clinicians, will have streamlined access to this cutting-edge cancer care platform," said Christina K. Lopes, co-founder and CEO of FidoCure.

"It is no secret that wide-scale access to veterinary oncology is sorely needed in the veterinary world. This partnership with FidoCure will enable Thrive Pet Healthcare clinicians across the country to better fulfill our mission of providing comprehensive pet care at every stage of life. As a veterinary oncologist, I'm incredibly excited we can more broadly deliver precision medicine to dogs with cancer. It is essential that the scientific advancements available to humans be made available to pets as well, and now we're doing just that with this partnership with FidoCure," said Dr. Mona Rosenberg, Thrive's National Specialty Director of Oncology and Director of Innovation in Clinical Oncology.

About Thrive Pet HealthcareThrive Pet Healthcare is a leading veterinary service network that uniquely delivers a continuum of care to pet families and services to veterinary hospitals. With an industry-first membership program and over 350 acute, primary, and specialty providers, Thrive Pet Healthcare offers personalized, accessible care through every stage of a pet's life and health. The veterinarian-founded organization provides premier benefits for practice staff while elevating privately held veterinary hospitals with innovative service and technology solutions. By focusing on the needs and aspirations of veterinary care providers, Thrive Pet Healthcare is supporting the wellbeing of the industry and raising the national bar for veterinary excellence. To learn more about Thrive Pet Healthcare, please visit http://www.thrivepetcare.com.

About FidoCureFidoCure is the first to bring the latest advances in human oncology - individualized, precision medicine - to dogs with cancer. We are a mission driven company that delivers the most sophisticated diagnostics and creates a tailored treatment plan for each dog. Our flagship product, FidoCure Next Generation DNA Sequencing Test, leverages technologies and therapies approved for human use, with additional data specific to canine cancer. With FidoCure, dogs with cancer receive access to the latest scientific advances in cancer care, from tests to treatment. FidoCure is backed by premier biotech investors including Polaris Ventures, A16Z, YCombinator and Global Brain. Learn more at fidocure.com.

For the original version on PRWeb visit: https://www.prweb.com/releases/2022/MM/prweb18751199.htm

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Thrive Pet Healthcare and FidoCure Announce An Expansive Pet Precision Health Partnership - Benzinga - Benzinga

DUBLIN--(BUSINESS WIRE)--The "Global Compound Management Market Size, Share & Trends Analysis Report by Type (Products, Service), by Sample Type (Chemical Compounds, Bio Samples), by Application, by End Use, by Region, and Segment Forecasts, 2022-2030" report has been added to ResearchAndMarkets.com's offering.

The global compound management market size is expected to reach USD 1.49 billion by the end of 2030, expanding at a CAGR of 15.6%.

Growing biopharmaceutical industry and biobanking sector is fueling the market growth. The growth of translational research and personalized medicine is driving the market.

Efficient compound management is tremendously important for the success of drug discovery, where traceability, reliability, speed, and throughput are fundamental. Maintaining samples at the precise temperature, under nitrogen or dry air to prevent fluctuations of stock concentrations, and in a dark environment to avoid photodegradation, can help ensure consistency and longevity of samples.

Compounds of high integrity lead to reliable results while locating drug candidates. Moreover, the collection, storage, and distribution of human biological samples support the development of the R&D industry. In addition, it aids to understand the mechanisms of diseases as well as supports the trend to provide personalized medicines.

Automated storage systems eliminate or reduce the risks and provide reliable and correct environmental conditions to protect samples from precipitation or degradation. A management system like Verso tracks sample data, including location and type, which enables the quick and easy finding of the sample. The fully automated systems improve the process of drug discovery by eliminating error-prone and time-consuming tasks.

North America dominated the market in 2018 owing to a strong base of biotechnology and pharmaceutical companies in the region. These companies are involved in drug discovery activities, which, in turn, led to the growth of the market in the region. The Asia Pacific market is anticipated to grow fast over the forecast period. This is attributed to ongoing studies in private-public collaborations, drug discovery, and government initiatives in the region.

Compound Management Market Report Highlights

Key Topics Covered:

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary

2.1. Market Outlook

2.2. Competitive Insights

Chapter 3. Compound Management Market Variables, Trends & Scope

3.1. Market Lineage Outlook

3.1.1. Parent market outlook

3.1.2. Related/ancillary market outlook

3.2. Penetration & Growth Prospect Mapping

3.3. Industry Value Chain Analysis

3.3.1. Reimbursement framework

3.4. Market Dynamics

3.4.1. Market driver analysis

3.4.1.1. Growing Drug Research Activities

3.4.1.2. Rising demand for outsourcing compound management services

3.4.1.3. High disease prevalence

3.4.1.4. Expansion of Pharma & Biopharma Research in Emerging Markets

3.4.2. Market restraint analysis

3.4.2.1. Large Capital Investments Required to Establish Compound Management Facilities

3.4.2.2. Quality issues related to compound management by the outsourcing provider

3.5. Compound Management Market Analysis Tools

3.5.1. Industry Analysis-Porter's

3.5.2. PESTEL Analysis

3.5.3. Major Deals & Strategic Alliances Analysis

3.5.4. COVID-19 Impact Analysis

Chapter 4. Compound Management Market: Type Estimates & Trend Analysis

Chapter 5. Compound Management Market: Sample Type Estimates & Trend Analysis

Chapter 6. Compound Management Market: Application Estimates & Trend Analysis

Chapter 7. Compound Management Market: End-Use Estimates & Trend Analysis

Chapter 8. Compound Management Market: Regional Estimates & Trend Analysis

Chapter 9. Competitive Profiles

For more information about this report visit https://www.researchandmarkets.com/r/r8bcjv

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The Worldwide Compound Management Industry is Expected to Reach $1.4 Billion by 2030 - ResearchAndMarkets.com - Business Wire

Myriad Genetics, Inc.

Study showed PGx testing helps clinicians prescribe fewer medications with gene-drug interactions

SALT LAKE CITY, July 12, 2022 (GLOBE NEWSWIRE) -- Major Depressive Disorder (MDD) remission rates were significantly improved when clinicians had access to GeneSight Psychotropic test results from Myriad Genetics, Inc. (NASDAQ: MYGN), according to a new nationwide study of nearly 2,000 veterans conducted by the U.S. Department of Veterans Affairs (VA).

The PRIME Care (Precision Medicine in Mental Health Care) study is the largest pharmacogenomic (PGx) randomized controlled trial (RCT) ever conducted in mental health. Results of the study were published in the July 2022 issue of the Journal of the American Medical Association (JAMA). The VA independently conducted and funded the study. Myriad Genetics provided the GeneSight tests for the study.

The number of veterans suffering from depression is a serious mental health issue. The PRIME Care study showed that veterans are more likely to achieve depression remission when GeneSight test results are available to inform medication treatment, said Paul J. Diaz, president and CEO, Myriad Genetics. We thank the VA and the investigators for conducting this important research. The results demonstrate how veterans may be helped by clinicians who provide personalized medication treatment and how such treatment can help make a positive impact on their lives, their families lives, and their communities.

In the PRIME Care study, 1,944 veteran patients with MDD received the GeneSight Psychotropic test and were randomized to receive results immediately (pharmacogenomic guided group) or after 24 weeks (usual care group). The study met its objective by achieving statistically significant results on both co-primary endpoints.

One co-primary endpoint showed that over 24 weeks, the pharmacogenomic guided group had a 28% greater likelihood (odds ratio = 1.28, 95% confidence interval 1.05-1.57, p=0.02) of achieving remission from MDD symptoms (defined as a score of five or less on the PHQ-9 depression symptom questionnaire). There were no identified harms from receiving GeneSight testing in the study.

Story continues

The VA PRIME Care Study further reinforces the body of evidence supporting the clinical utility of the GeneSight test as an important tool to inform medication selection in MDD treatment. The study showed a meaningful increase in remission rates for patients whose providers had access to GeneSight test results, said Jay Elliott, vice president, medical affairs of mental health, Myriad Genetics. Remission represents a reduction in symptoms and return to normal or near-normal function, which is considered the optimal treatment goal for both providers and patients.

Another co-primary endpoint showed that patients in the usual care group were approximately two-fold more likely (odds ratio = 2.08, 95% confidence interval 1.52-2.84, p=0.005) to be prescribed medications with substantial predicted gene-drug interactions compared to the pharmacogenomic guided group in the first 30 days after randomization.

Among patients with MDD, provision of pharmacogenomic testing for drug-gene interactions reduced prescription of medications with predicted drug-gene interactions compared with usual care, according to the JAMA publication of the PRIME Care study.

Major Depressive Disorder is one of the most common conditions associated with military service and combat exposure, increases suicide risk, and worsens the course of common medical conditions, making it a leading cause of disability and mortality, according to the VA PRIME Care study website. In fact, the VA estimates that one in eight to 10 veterans has major depression, requiring treatment with psychotherapy and/or antidepressants.1

_______________1 U.S. Department of Veterans Affairs. https://www.research.va.gov/topics/depression.cfm

About the PRIME Care Study

The 24-week PRIME Care study was conducted among 1,944 Veterans who were diagnosed with Major Depressive Disorder at more than 20 VA Medical Centers around the country. The study focused on whether and how patients and providers use genetic test results given to them at the time an antidepressant is to be initiated to treat MDD and whether use of the genetic test results improves patient outcomes. Results were calculated at weeks four, eight, 12, 18, and 24.

The study was a two-arm, parallel-groups comparison of patient/provider dyads randomly assigned to receive the results of the GeneSight test at the time the planned treatment is initiated (intervention group) OR results returned after 24 weeks of treatment as usual (delayed results group).

The study incorporated a widely used depression questionnaire, the PHQ-9, to assess severity of depression symptoms. A score of five or less indicates remission of depression symptoms. Patients were required to have a score of nine or more on the PHQ-9 to enroll in the PRIME Care study.

About the GeneSight Test

The GeneSight Psychotropic test from Myriad Genetics is the category-leading pharmacogenomic test for 64 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions. The GeneSight test can help inform clinicians about how a patients genes may impact how they metabolize and/or respond to certain psychiatric medications. It is designed to provide information that may help avoid the trial-and-error process that often takes place when patients are prescribed certain mental health medications. Tens of thousands of clinicians have ordered the GeneSight test for more than 1.5 million patients in order to receive genetic information that is unique to each patient. GeneSight can be easily ordered by psychiatrists, general practitioners, nurse practitioners and other prescribers via a secure portal. The test can be administered in a home-based kit or a providers office using a simple cheek swab. GeneSight test results are typically provided in two days and supplement other information considered by a clinician as part of a comprehensive medical assessment. Learn more at GeneSight.com.

About Myriad Genetics

Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. Fast Company named Myriad among the Worlds Most Innovative Companies for 2022. For more information, visit http://www.myriad.com.

Myriad, the Myriad logo, BRACAnalysis, BRACAnalysis CDx, Colaris, Colaris AP, MyRisk, Myriad MyRisk, MyRisk Hereditary Cancer, MyChoice CDx, Prequel, Prequel with Amplify, Amplify, Foresight, Precise, FirstGene, Health.Illuminated., RiskScore, Prolaris, GeneSight, and EndoPredict are trademarks or registered trademarks of Myriad Genetics, Inc. 2022 Myriad Genetics, Inc. All rights reserved.

Media Contact:Sharvari Dayal(330)-354-7150sharvari.dayal@myriad.com

Investor Contact:Foster Harris(919) 998-8379foster.harris@myriad.com

Continued here:
Access to Myriad Genetics GeneSight Test Improves Depression Remission Rates In Largest Ever Mental Health PGx Randomized Controlled Trial - Yahoo...

DUBLIN--(BUSINESS WIRE)--The "Global Induced Pluripotent Stem Cell (iPSC) Industry Report, 2022" report has been added to ResearchAndMarkets.com's offering.

Since the discovery of induced pluripotent stem cell (iPSC) technology in 2006, significant progress has been made in stem cell biology and regenerative medicine. New pathological mechanisms have been identified and explained, new drugs identified by iPSC screens are in the pipeline, and the first clinical trials employing human iPSC-derived cell types have been initiated.

iPSCs can be used to explore the causes of disease onset and progression, create and test new drugs and therapies, and treat previously incurable diseases.

Other applications of iPSCs include their use as research products, as well as their integration into 3D bioprinting, tissue engineering, and clean meat production. Technology allowing for the mass-production and differentiation of iPSCs in industrial-scale bioreactors is also advancing at breakneck speed.

iPSC Derived Clinical Trials

The first clinical trial using iPSCs started in 2008, and today, that number has surged worldwide. Most of the current clinical trials do not involve the transplant of iPSCs into humans, but rather, the creation and evaluation of iPSC lines for clinical purposes. Within these trials, iPSC lines are created from specific patient populations to determine if these cell lines could be a good model for a disease of interest.

The therapeutic applications of induced pluripotent stem cells (iPSCs) have also surged in recent years. Since the discovery of iPSCs in 2006, it took only seven years for the first iPSC-derived cell product to be transplanted into a human patient in 2013. Since then, iPSC-derived cells have been used within a rapidly growing number of preclinical studies, physician-led studies, and formal clinical trials worldwide.

Key Topics Covered:

1. Report Overview

2. Introduction

3. Current Status of iPSC Industry

3.1 Progress Made in Autologous Cell Therapy Using iPSCs

3.2 Manufacturing Timeline for Autologous iPSC-Derived Cell Products

3.3 Cost of iPSC Production

3.4 Automation in iPSC Production

3.5 Allogeneic iPSCs Gaining Momentum

3.6 Share of iPSC-Based Research Within the Overall Stem Cell Industry

3.7 Major Focus Areas of iPSC Companies

3.8 Commercially Available iPSC-Derived Cell Types

3.9 Relative Use of iPSC-Derived Cell Types in Toxicology Testing Assays

3.10 Currently Available iPSC Technologies

4. History of Induced Pluripotent Stem Cells (iPSCs)

5. Research Publications on iPSCs

6. iPSC: Patent Landscape Analysis

6.1 Legal Status of iPSC Patents

6.2 Patents by Assignee Organization Type

6.3 Ownership of Patent Families by Assignee Type

6.4 Top Inventors of iPSC Patents

6.5 Top Ten iPSC Inventors

6.6 Most Cited Five iPSC Patents

6.7 Leading Patent Filing Jurisdictions

6.8 Number of Patent Families by Year of Filing

6.9 Patents Representing Different Disorders

6.10 iPSC Patents on Preparation Technologies

6.11 Patents on Cell Types Differentiated from iPSCs

6.12 Patent Application Trends Disease-Specific Technologies

7. iPSC: Clinical Trial Landscape

7.1 Literature and Database Search

7.2 Number of iPSC Clinical Trials by Year

7.3 iPSC Study Designs

7.4 iPSC-Based Clinical Trials With Commercialization Potential

8. Research Funding for iPSCs

8.1 Value of NIH Funding for iPSC Research

8.2 Partial List of NIH Funded iPSC Research Projects in 2022

9. M&A, Collaborations & Funding Activities in iPSC Sector

10. Generation of Induced Pluripotent Stem Cells: An Overview

10.1 Reprogramming Factors

10.2 Integrating iPSC Delivery Methods

10.3 Non-Integrative Delivery Systems

10.4 Comparison of Delivery Methods for Generating iPSCs

10.5 Genome Editing Technologies in iPSC Generation

11. Human iPSC Banking

11.1 Cell Sources for iPSC Banking

11.2 Reprogramming Methods Used in iPSC Banking

11.3 Factors Used in Reprogramming in Different Banks

11.4 Workflow in iPSC Banks

11.5 Existing iPSC Banks

12. Biomedical Applications of iPSCs

12.1 iPSCs in Basic Research

12.2 iPSCs in Drug Discovery

12.3 iPSCs in Toxicology Studies

12.4 iPSCs in Disease Modeling

12.5 iPSCs in Cell-Based Therapies

12.6 Other Novel Applications of iPSCs

12.7 iPSCs in Animal Conservation

13. Market Overview

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/mg6l5h

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Global Induced Pluripotent Stem Cell (iPSC) Market Report 2022: Rising Applications of iPSCs Fueling Industry Growth - ResearchAndMarkets.com -...

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Chicago, July 15, 2022 (GLOBE NEWSWIRE) -- According to the new market research report Research Antibodies and Reagents Market by Product (Antibodies (Type, Form, Source, Research Area), Reagents), Technology (Western blot, Flow Cytometry, ELISA), Application (Proteomics, Genomics), End User (Pharma, Biotech, CROs) - Global forecast to 2027, published by MarketsandMarkets, the global Research Antibodies and Reagents Market are projected to reach USD 16.1 billion by 2027 from USD 11.6 billion in 2022, at a CAGR of 6.7% during the forecast period.

Browse in-depth TOC on Research Antibodies Market and Research Reagents Market244 Tables46 Figures285 Pages

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The Factors responsible for driving the market are, increasing growth in proteomics and genomics research, growing demand for high-quality antibodies for research reproducibility, and increasing R&D investments in the life sciences industry.

The antibodies segment is expected to grow at the highest CAGR during the forecast period

On the basis of product, the research antibodies and reagents market are segmented into reagents and antibodies. The antibodies segment is expected to grow at highest CAGR in forecast periods (2022-2027). Factors such as antibodies use for research offer high specificity and selectivity and are used ubiquitously in biochemical and medical research for protein-target identification, regulatory characterization, and discovery, are driving the market.

The primary antibodies segment is accounts for the largest share of the research antibodies and reagents market

On the basis of type, the research reagents market are segmented into primary antibodies and secondary antibodies. In 2021, the primary antibodies segment held the largest share of the global research antibodies market. This segment is witnessing a strong growth due to the use of these antibodies in numerous types of assay formats. Their accuracy in biomarker detection and high specificity and sensitivity are also driving the market.

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The media & sera reagent is expected to account for the largest share of the market, by type, in 2021

On the Basis of type, the research antibodies and reagents market are segmented into media &sera, stains & dyes, fixatives, buffers, solvents, enzymes, probes, and other reagents. In 2021, the media & sera reagent segment held the largest share of the global research antibodies market. Factors such as use of these components in all types of assays, cell cultures, and techniques is driving the market.

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The western blotting segment is expected to account for the largest share of the market, by technology, in 2021

On the basis of technology, the research antibodies and reagents market are segmented into western blotting, flow cytometry, ELISA, Immunohistochemistry, Immunofluorescence, Immunoprecipitation, and other technologies. The Western blotting segment is expected to grow at highest CAGR in forecast periods (2022-2027). Factors such as the high adoption of technique in proteomic and genomic research. The results achieved are unique, easy to interpret, and unambiguous, making it suited for evaluating levels of protein expression in cells, protein purification, and comparing the expression of a target protein from various tissues.

The drug development applications segment is expected to grow at the highest CAGR during the forecast period

On the basis of application, the research antibodies and reagents market are segmented into proteomics, drug development and Genomics. The drug development segment is expected to grow at highest CAGR in forecast periods (2022-2027). Factors such increasing demand for personalized medicine and government funding & initiatives in the sector are the key market drivers for this segment.

The pharmaceutical & biotechnology segment is expected to grow at the highest CAGR during the forecast period

On the basis of end user, the research antibodies and reagents market are segmented into the pharmaceutical & biotechnology companies, academic & research institutions, and Contract Research Organizations. Factors such as the growth of this segment is due to antibodies provide a gold standard for the detection of a biomolecule or a pathway and are even capable of detecting specific changes in potential drug targets. Moreover, highly specific reagents are used to measure pharmacokinetic parameters in the preclinical and clinical development of biological drugs are the key market drivers for this segment.

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The APAC market is expected to grow at the highest CAGR during the forecast period

The Asia Pacific research reagents market is expected to grow at the highest CAGR from 2022 to 2027. Factors such as increasing proteomics and genomics research and growing research funding, increasing investments by pharmaceutical and biotechnology companies are driving the market.

Prominent market players in Research Antibodies Market and Research Reagents Market are:

Thermo Fisher Scientific, Inc. (US),

Merck KGaA (Germany),

Abcam plc (UK),

Becton, Dickinson, and Company (US),

Bio-Rad Laboratories (US),

Cell Signaling Technology (US),

F. Hoffmann-La Roche (Switzerland),

Danaher Corporation (US),

Agilent Technologies (US),

PerkinElmer (US),

Lonza (Switzerland),

GenScript (China), and

BioLegend (US).

Browse Adjacent Markets:Biotechnology Market Research Reports & Consulting

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Flow Cytometry Market by Technology (Cell-based, Bead-based), Product (Analyzer, Sorter, Reagents, Consumables, Software), End user (Academia, Research Labs, Hospitals, Clinical Laboratories, Pharma-Biotech Cos), Application - Global Forecasts to 2025https://www.marketsandmarkets.com/Market-Reports/flow-cytometry-market-65374584.html

Custom Antibody Market by Service (Antibody Production, Characterization, Immunization, Fragmentation), Type (Monoclonal, Polyclonal, Recombinant), Source (Mouse, Rabbit), Research Area (Oncology, Immunology), and End Users - Global Forecast to 2023https://www.marketsandmarkets.com/Market-Reports/custom-antibody-market-164328301.html

Continued here:
Research Antibodies and Reagents Market worth $16.1 Billion by 2027 Exclusive Report by MarketsandMarkets - Yahoo Finance

Custom Antibody Market Is Expected To Reach USD 742.27 Million By 2029 At A CAGR Of 10.3 percent.

Maximize Market Research has published a report on theGlobal Custom Antibody Market that provides a detailed analysis for the forecast period of 2022 to 2029.

Custom Antibody Market Scope:

The report provides comprehensive market insights for industry stakeholders, including an explanation of complicated market data in simple language, the industrys history and present situation, as well as expected market size and trends. The research investigates all industry categories, with an emphasis on key companies such as market leaders, followers, and new entrants. The paper includes a full PESTLE analysis for each country. A thorough picture of the competitive landscape of major competitors in the Custom Antibody market by goods and services, revenue, financial situation, portfolio, growth plans, and geographical presence makes the study an investors guide.

Request For Free Sample @https://www.maximizemarketresearch.com/request-sample/34046

Custom Antibody Market Overview:

To accommodate any host needs, customised antibodies can be produced in a mouse, rat, or hamster. Companies offer a wide variety of antibodies based on the needs of the researcher. Polyclonal and monoclonal antibodies, recombinant monoclonal antibodies, hybridoma antibodies, polyclonal recombinant antibodies, and others are available in the market as customised antibodies. For all types and stages of antibody manufacturing, including peptide design, synthesis, carrier protein conjugation, animal immunisation, serum collection, hybridoma fusion, and final antibody purification, businesses are now providing full support services.

Custom Antibody MarketDynamics:

The strong need for research, expanding government assistance, changing illness profiles, developing public-private collaborations, and rising funding activities are all contributing to the expansion of the bespoke antibody market. These aspects also help biotechnology perform better overall. However, depending on the animals used to produce them, the generation of monoclonal and polyclonal antibodies varies. The cost is also influenced by the packages of customised antibodies required for various applications that are provided by various providers, which restricts market expansion.

A key area of research in the healthcare sector, personalised medicine has now permeated mainstream clinical practise and is revolutionising how many diseases are diagnosed, categorised, and treated. These developments are especially noticeable in oncology. The number of personalised medicine medications, therapies, and diagnostic products has grown since 2006, and this trend is anticipated to continue in the upcoming years, according to the Personalized Medicine Coalition study (2020). Additionally, over the past five years, biopharmaceutical companies have almost doubled their R&D expenditures in personalised medicine; over the following five years, this expenditure is predicted to rise by 33 percent. Over the past few years, there has been a surge in the need for protein treatments, such as hormones, vaccines, monoclonal antibodies, blood factors, and therapeutic enzymes

Custom Antibody MarketRegional Insights:

A key area of research in the healthcare sector, personalised medicine has now permeated mainstream clinical practise and is revolutionising how many diseases are diagnosed, categorised, and treated. These developments are especially noticeable in oncology. The number of personalised medicine medications, therapies, and diagnostic products has grown since 2006, and this trend is anticipated to continue in the upcoming years, according to the Personalized Medicine Coalition study (2020). Additionally, over the past five years, biopharmaceutical companies have almost doubled their R&D expenditures in personalised medicine; over the following five years, this expenditure is predicted to rise by 35 percent. Over the past few years, there has been a surge in the need for protein treatments, such as hormones, vaccines, monoclonal antibodies, blood factors, and therapeutic enzymes.

Custom Antibody MarketSegmentation:

By Services:

By Type:

By Source:

By Research area:

By End-Users:

Custom Antibody Market Key Competitors:

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Maximize Market Research is a multifaceted market research and consulting company with professionals from several industries. Some of the industries we cover include medical devices, pharmaceutical manufacturers, science and engineering, electronic components, industrial equipment, technology and communication, cars and automobiles, chemical products and substances, general merchandise, beverages, personal care, and automated systems. To mention a few, we provide market-verified industry estimations, technical trend analysis, crucial market research, strategic advice, competition analysis, production and demand analysis, and client impact studies.

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Global Custom Antibody Market Is Expected To Reach USD 742.27 Million At A CAGR Of 10.3% And Forecast To 2029 - Digital Journal

The Personalized Medicine Coalition, representing innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services, and products to benefit patients and health systems.

Personalized medicine is an evolving field in which physicians use diagnostic tests to determine which medical treatments will work best for each patient or use medical interventions to alter molecular mechanisms that impact health. By combining data from diagnostic tests with an individuals medical history, circumstances and values, health care providers can develop targeted treatment and prevention plans with their patients.

To understand how quickly personalized treatments and diagnostic tools are reaching the United States market, PMC recently conducted its seventh annual analysis of the Food and Drug Administration's activities in personalized medicine. With personalized medicines accounting for more than 25 percent of newly approved drugs for each of the last seven years and topping one-third of new drug approvals for four of the last five, the findings leave no question that the era of personalized medicine is upon us, presenting both opportunities and challenges for patients and health systems.

Use the link provided below to access a PDF version of the report. Personalized Medicine at FDA: The Scope & Significance of Progress in 2021

Excerpt from:
Personalized Medicine Coalition - Precision Medicine Advocacy and ...

Most medical treatments are designed for the "average patient" as a one-size-fits-all-approach, which may be successful for some patients but not for others. Precision medicine, sometimes known as "personalized medicine" is an innovative approach to tailoring disease prevention and treatment that takes into account differences in people's genes, environments, and lifestyles. The goal of precision medicine is to target the right treatments to the right patients at the right time.

Advances in precision medicine have already led to powerful new discoveries and FDA-approved treatments that are tailored to specific characteristics of individuals, such as a person's genetic makeup, or the genetic profile of an individual's tumor. Patients with a variety of cancers routinely undergo molecular testing as part of patient care, enabling physicians to select treatments that improve chances of survival and reduce exposure to adverse effects.

Precision care will only be as good as the tests that guide diagnosis and treatment. Next Generation Sequencing (NGS) tests are capable of rapidly identifying or 'sequencing' large sections of a person's genome and are important advances in the clinical applications of precision medicine.Patients, physicians and researchers can use these tests to find genetic variants that help them diagnose, treat, and understand more about human disease.

The FDA is working to ensure the accuracy of NGS tests, so that patients and clinicians can receive accurate and clinically meaningful test results.

The vast amount of information generated through NGS poses novel regulatory issues for the FDA. While current regulatory approaches are appropriate for conventional diagnostics that detect a single disease or condition (such as blood glucose or cholesterol levels), these new sequencing techniques contain the equivalent of millions of tests in one. Because of this, the FDA has worked with stakeholders in industry, laboratories, academia, and patient and professional societies to develop a flexible regulatory approach to accommodate this rapidly evolving technology that leverages consensus standards, crowd-sourced data, and state-of-the-art open-source computing technology to support NGS test development. This approach will enable innovation in testing and research, and will speed access to accurate, reliable genetic tests.

InApril 2018, the FDA issued two final guidances that recommend approaches to streamline the submission and review of data supporting the clinical and analytical validity of NGS-based tests. These recommendations are intended to provide an efficient and flexible regulatory oversight approach: as technology advances, standards can rapidly evolve and be used to set appropriate metrics for fast growing fields such as NGS. Similarly, as clinical evidence improves, new assertions could be supported. This adaptive approach would ultimately foster innovation among test developers and improve patients' access to these new technologies.

Thefinal guidance "Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics" allows developers to use data from FDA-recognized public databases of genetic variants to help support a test's clinical validity and outlines how database administrators can seek recognition for their databases if they meet certain quality recommendations. This approach incentivizes data sharing and provides a more efficient path to market.

More information about database recognition is available on the FDAs Recognition of Public Human Genetic Variants Databases webpage.

The final guidance "Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases" offers recommendations for designing, developing and validating NGS tests. The guidance also encourages community engagement in developing NGS-related standards by standards developing organizations (SDOs) since standards can more rapidly evolve with changes in technology and knowledge and can therefore be used to set appropriate metrics such as specific performance thresholds for fast growing fields such as NGS.

The FDA created precisionFDA, a cloud-based community research and development portal that engages users across the world to share data and tools to test, pilot, and validate existing and new bioinformatics approaches to NGS processing. Individuals and organizations in the genomics community can find more information and sign up to participate at http://precision.fda.gov.

Please contact us with any questions about the FDA's precision medicine efforts at OIRPMgroup@fda.hhs.gov.

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Precision Medicine | FDA

DUBLIN, June 7, 2022 /PRNewswire/ -- The "Biomarkers Market - Global Outlook & Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.

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The global biomarkers market is expected to grow at a CAGR of 11.44%.

In-depth Analysis and Data-driven Insights on the Vendor Landscape, Competitive Analysis, and Critical Market Strategies are Included in this Global Biomarkers Market Report

Biomarkers are increasingly useful tools to predict prognosis and response to therapy in cancer patients. Furthermore, it allows to improve understanding of mechanisms of action and resistance to treatment.

GLOBAL BIOMARKERS MARKET SEGMENTATION

Oncology dominated the indication segment because biomarkers are being largely used for cancer research and diagnostics due to its high prevalence worldwide. Biomarkers in the field of oncology has revolutionized the diagnostics and treatment pathways.

Diagnostics dominated the application segment. However, the application of biomarkers in drug discovery & development is expected to grow significantly during the forecast period because biomarkers studies is expected to become an integral part of the drug development process with the aim of developing more effective drugs at a lower cost

Diagnostic biomarker dominated the type of segment as diagnostic biomarker studies have entered a new era where it holds promise for early diagnosis and effective treatment of many diseases.

GEOGRAPHICAL ANALYSIS

North America dominated the geography because biomarkers have been in use highly for diagnostic purposes, drug discovery & development, and precision medicine. The increase in R&D expenditures and fundings for biomarker-driven drug discovery & development and precision medicine is one of the major driving factors in all the regions.

APAC is anticipated to exhibit the highest CAGR of 13.96% during the forecast period. Increasing developments and incorporation of advanced technologies to enhance the biomarker-based testing and increasing demand for biomarkers in drug development and personalized medicine are one of the primary factors in the region.

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KEY HIGHLIGHTS

Increased Adoption of Biomarkers in Personalized Medicine is driving the global biomarkers market growth. As many healthcare settings have gained interest in personalized/precision medicine, many vendors have increased the studies focusing on identifying biomarkers to provide healthcare system solutions to them.

Increasing focus on digital biomarkers will also drive the global Currently, several digital biomarkers are being tested for feasibility and reliability in Parkinson's and Alzheimer's disease and clinical outcome assessments.

Increasing discovery of epigenetic biomarkers for oncology is also driving the biomarker technologies market. There are more emerging companies increasing their research & development focus on discovering more epigenetics to diagnose various types of cancers.

Technological Advancements in Biomarker Discovery are also positively impacting the biomarkers diagnostics industry. For instance, a recent development in portable biosensors allows rapid, accurate, and on-site detection of biomarkers, which helps prevent disease spread by controlling sources.

VENDOR ANALYSIS

Multiple companies partnering and investing in biomarkers research and development will help the companies to innovate new drugs and reduce the economic burden.

Key Vendors

Other Prominent Vendors

Key Topics Covered:

1 Research Methodology

2 Research Objectives

3 Research Process

4 Scope & Coverage4.1 Market Definition4.1.1 Inclusions4.1.2 Exclusions4.1.3 Market Estimation Caveats4.2 Base Year4.3 Scope of the Study4.4 Market Segments4.4.1 Market Segmentation by Indication4.4.2 Market Segmentation by Application4.4.3 Market Segmentation by Type4.4.5 Market Segmentation by Geography

5 Report Assumptions & Caveats5.1 Key Caveats5.2 Currency Conversion5.3 Market Derivation

6 Market at a Glance

7 Introduction7.1 Overview

8 Market Opportunities & Trends8.1 Increased Adoption of Biomarkers in Personalized Medicine8.2 Increasing Focus on Digital Biomarkers8.3 Increased Discovery of Epigenetic Biomarkers in Oncology

9 Market Growth Enablers9.1 Increase in the Number of Pipeline Biomarkers9.2 Rising Adoption of Biomarkers in Disease Diagnostics9.3 Technological Advancements in Biomarker Discovery

10 Market Restraints10.1 High Cost and Time-Consuming Development10.2 High Number of False Discoveries10.3 Strict Regulations and Ethics for Biomarker Validation & Qualification

11 Market Landscape11.1 Market Overview11.2 Market Size & Forecast11.2.1 Insights by Indication11.2.2 Insights by Application11.2.3 Insights by Type11.2.4 Insights by Geography11.3 Five Forces Analysis

12 Indication12.1 Market Snapshot & Growth Engine12.2 Market Overview12.3 Oncology12.4 Cardiology12.5 Neurology12.6 Immunology12.7 Others

13 Application13.1 Market Snapshot & Growth Engine13.2 Market Overview13.3 Diagnostics13.4 Drug Discovery & Development13.5 Personalized Medicine13.6 Others

14 Type14.1 Market Snapshot & Growth Engine14.2 Market Overview14.3 Diagnostic Biomarkers14.4 Monitoring Biomarkers14.5 Prognostic Biomarkers14.6 Predictive Biomarkers14.7 Susceptibility Biomarkers14.8 Other Biomarkers

15 Geography15.1 Market Snapshot & Growth Engine15.2 Geographic Overview

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Global Biomarkers Markets Research 2022-2027: Increased Adoption of Biomarkers in Personalized Medicine / Focus on Digital Biomarkers / Increased...

Brussels, Belgium, June 06, 2022 (GLOBE NEWSWIRE) --

Description:

Precision medicine, sometimes known as "personalized medicine" is an innovative approach to tailoring disease prevention and treatment based on the individuals unique characteristics and genetic make-up. Precision medicine software (platforms, data-sharing networks, clinical decision support software, AI-enabled, etc.) provides the healthcare/life sciences community with integrated data and data-driven insights to strengthen their precision medicine program.

The Shift from the Dominant One-Size-Fits-All Approach to Personalized Care

The precision medicine approach promises better clinical outcomes, safer medicines, and less wastage/cost savings. With the increasing demand to provide value to healthcare systems, drug developers have started to move away from the traditional one-size-fits-all approach to the personalized care approach.

In 2020, the FDA approved 20 personalized drugs and biologics (39% of the new approvals). Precision medicines accounted for a quarter or more of all new drugs approved by the FDA each year in the past five years. With the growing interest and increasing opportunities in precision medicine, the demand for precision medicine software is also anticipated to grow.

Favorable Government Initiatives

Realizing the long-term benefits of personalized care in improving population health and reducing healthcare costs, governments across the globe are supporting advanced treatments like precision medicine through initiatives, regulatory changes, and/or funding research. For instance, in the US, The Oncology Care Model, a specialty payment and delivery model developed by the CMS Innovation Center is providing incentives that have led to a surge of large community provider networks implementing precision medicine initiatives. Some of the other programs to advance the research/use of precision medicine include The Precision Medicine Initiative (PMI), All of Us Research Program, precision FDA, and Million Veteran Program. In addition, FDA issued seven guidance documents in 2020 related to precision medicine. All these efforts would eventually boost the demand for precision medicine software.

Vast Growth Opportunities in Oncology

Precision medicine holds great promise for reshaping the way cancer is treated. The increasing prevalence of cancer and growing funding for cancer research would propel the adoption of precision medicine in oncology. High-quality patient datasets are the foundation to bring precision oncology into clinical practice. Thus, providing great opportunities for precision oncology software providers. Some of the recent activities in this space include:

Key Challenges: Precision Medicine Software Market

For the emergence of precision medicine in every disease area, the industry needs to know how to optimize the use of big data with the increase in the amount of genomics, health, and lifestyle information.

Further, the high cost of deployment, issues related to the secure storage of large volumes of sequenced data, lack of reimbursement for precision medicine-based treatments, and the shortage of expert technicians/bioinformaticians are some of the key challenges faced by this industry.

Competitive Landscape Analysis: Precision Medicine Software Market

The global precision medicine software market is highly competitive and fragmented. Some of the key/promising players operating in the precision medicine software market are Syapse, Fabric Genomics, Sophia Genetics, 2bprecise, PierianDx, Inc., PhenoTips, Foundation Medicine, Inc., GenomOncology, LLC, Translational Software, Inc., LifeOmic Health, LLC, Sunquest Information Systems, Inc., Tempus, Human Longevity, Inc., and N-of-One Inc.

Explore Detailed Insights on Precision Medicine Software Market @ https://meditechinsights.com/precision-medicine-software-market/

About Medi-Tech Insights:

Medi-Tech Insights is a healthcare-focused business research & insights firm. Our clients include Fortune 500 companies, blue-chip investors & hyper-growth start-ups. We have successfully completed 100+ projects in Healthcare IT, Medical Technology, Medical Devices & Pharma Services.

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Global Precision Medicine Software Market is anticipated to witness a lucrative CAGR of 10% - GlobeNewswire

A small clinical trial conducted by Memorial Sloan Kettering Cancer Center found that every single rectal cancer patient who received an experimental immunotherapy treatment had their cancer go into remission.

One participant, Sascha Roth, was preparing to travel to Manhattan for weeks of radiation therapy when the results came in,Memorial Sloan Ketteringsaid. That's when doctors gave her the good news: She was now cancer-free.

"I told my family," Roth told The New York Times. "They didn't believe me."

These same remarkable results would be seen in14 patientsto date. The study was published Sundayin the New England Journal of Medicine. All of the patients had rectal cancer in a locally advanced stage, with a rare mutation calledmismatch repair deficiency(MMRd).

They were given six months of treatment with an immunotherapy drug called dostarlimab, from the pharmaceutical company GlaxoSmithKline, which helped fund the research. The cancer vanished in every single one of them undetectable by physical exam, endoscopy, PET scans or MRI scans, the researchers said.

The drug costs about $11,000 per dose, The Times reports. It was administered to each patient every three weeks for six months, and it works by exposing cancer cells so the immune system can identify and destroy them.

"This new treatment is a type of immunotherapy, a treatment that blocks the 'don't eat me' signal on cancer cells enabling the immune system to eliminate them," CBS News medical contributor Dr. David Agus explains.

"The treatment targets a subtype of rectal cancer that has the DNA repair system not working. When this system isn't working there are more errors in proteins and the immune system recognizes these and kills the cancer cells."

After six months or more of follow-up, the patients continued to show no signs of cancer without the need for the standard treatments of surgery, radiation and chemotherapy and the cancer has not returned in any of the patients, who have now been cancer-free for a range of six to 25 months after the trial ended.

"Amazing to have every patient in a clinical trial respond to a drug, almost unheard of," Agus said, adding that it "speaks to the role of personalized medicine that is identifying a subtype of cancer for a particular treatment, rather than treating all cancers the same."

Another surprise from the study was that none of the patients suffered serious side effects.

"Surgery and radiation have permanent effects on fertility, sexual health, bowel and bladder function," Dr. Andrea Cercek, a medical oncologist and principal investigator in the study, said in an MSKnews release. "The implications for quality of life are substantial, especially in those where standard treatment would impact childbearing potential. As the incidence of rectal cancer is rising in young adults, this approach can have a major impact."

"It's incredibly rewarding," Cercek said, "to get these happy tears and happy emails from the patients in this study who finish treatment and realize, 'Oh my God, I get to keep all my normal body functions that I feared I might lose to radiation or surgery.'"

Researchers agree the trial needs to now be replicated in a much bigger study, and noted that the small study focused only on patients who had a rare genetic signature in their tumors. But they say that seeing complete remission in 100% of patients tested is a very promising early signal.

Dr. Hanna K. Sanoff of the University of North Carolina's Lineberger Comprehensive Cancer Center, who was not involved in the study, said it is not yet clear if the patients are cured.

"Very little is known about the duration of time needed to find out whether a clinical complete response to dostarlimab equates to cure," Dr. Sanoff wrote in an editorial accompanying the paper.

But she noted, "These results are cause for great optimism."

The trial is expected to include about 30 patients, which will give a fuller picture of how safe and effective dostarlimab is in this group.

"While longer follow-up is needed to assess response duration, this is practice-changing for patients with MMRd locally advanced rectal cancer," said study co-leader Dr. Luis Diaz Jr., head of the division of solid tumor oncology at MSK.

Natacha Larnaud is a social TV producer for CBS News.

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Every patient in this experimental drug trial saw their cancer disappear, researchers say - CBS News

ReportLinker

The growth in the Middle East molecular diagnostics market is expected to be driven by factors such as the increasing prevalence of infectious diseases and various types of cancer in the Middle East, rising awareness of personalized medicine and its acceptance, coupled with the significant number of funding for executing R&D in Middle East region.

New York, June 07, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Middle East Molecular Diagnostics Market - Country Analysis: Focus on Product, Testing Location, Technology, Application, End User, and Country Data - Analysis and Forecast, 2021-2031" - https://www.reportlinker.com/p06284299/?utm_source=GNW

Market Lifecycle Stage

Diagnostics is a well-developed market with an integral part of medical decision-making -aid in acquiring information for a wide range of treatment dissemination, accentuating their criticality in healthcare.Molecular diagnostics has a critical role in the precision medicine approach, as it ensures the safe and effective application of targeted therapeutics.

Most of the players in the Middle East molecular diagnostics market offer products encompassing the kits and reagents, instruments, and software categories.

Increasing investments in the R&D for molecular diagnostics is one of the major opportunities in the Middle East molecular diagnostics market. Several diagnostics and pharmaceutical companies are working collaboratively to develop next-generation sequencing (NGS), polymerase chain reaction (PCR), immunohistochemistry (IHC), in-situ hybridization (ISH), microarray, nucleic acid amplification-, or mass spectrometry-based molecular diagnostics for the applications in several disease indications in order to enable efficient diagnosis, treatment selection, dosage selection, and treatment monitoring.

Impact

Several techniques are employed in modern molecular diagnostics to detect and quantify specific DNA or RNA sequences, as well as proteins. Some of these additional technologies are described briefly below: Immunohistochemistry (IHC): IHC is the utilization of monoclonal and polyclonal antibodies for the detection of specific antigens in tissue sections. In Situ Hybridization (ISH or FISH): This is a technique that unwinds DNA or RNA in the sample and employs a labeled DNA or RNA strand (probe), which hybridizes with the complementary sequence on an unwound strand (target). Polymerase Chain Reaction (PCR): Polymerase chain reaction (PCR) allows researchers to amplify a small amount of DNA to quantities that can be used for analysis. PCR has ushered in a golden era in molecular diagnostics. Sequencing (CE, NGS): The sequencing allows the mapping of the entire sequence of the nucleotides that comprise a strand of DNA. As of 2020, sequencing can be achieved through capillary electrophoresis (CE) or through multiple next-generation sequencing (NGS) methods.

Impact of COVID-19

The current Middle East molecular diagnostics market comprises software, instruments, and consumables.It has been noticed that there has been a reduction in the capacity or shutdowns of laboratories and other research institutions, that have led to reduced usage of instruments, consumables, and software related to research.

Overall, the impact of COVID-19 on the Middle East molecular diagnostics market size has been low-moderate.Some of the market players have reported a slight decline in sales.

However, financials are already on their way to recovery.The decline in revenues was mostly a result of the initial phases of the COVID-19 pandemic, which comprised complete lockdowns across countries and major cities, thus interrupting the supply chain.

The timeline of impact spanned the end of the first quarter and the second quarter of 2020 for most of the key markets across the Middle East. However, the pandemic has played a key role in enhancing the growth prospects of molecular diagnostics and is expected to indirectly aid in improving the market growth outlook.

Market Segmentation

Segmentation 1: by Product Systems Kits and Consumables Software and Other Products

The Middle East molecular diagnostics market in the products segment is expected to be dominated by the kits and consumables segment. This is due to an increasing number of molecular diagnostics kit providers offering kits and services to their end users.

Segmentation 2: by Testing Location Laboratory Testing Point-of-Care Testing

The Middle East molecular diagnostics market is dominated by the laboratory testing segment owing to an increasing number of molecular diagnostic laboratories in the Middle East region involved in undertaking various routine testing for different chronic and acute diseases.

Segmentation 3: by Technology Polymerase Chain Reaction (PCR) Next-Generation Sequencing (NGS) Isothermal Nucleic Acid Amplification Technology (INAAT) Microarray In-Situ Hybridization (ISH) Immunohistochemistry (IHC) Other Technologies

The polymerase chain reaction segment dominates the Middle East molecular diagnostics market due to the increasing number of PCR testing being carried out in the Middle East laboratories for diagnosis.

Segmentation 4: by Application Core Molecular Diagnostics Reproductive Genetics Companion Diagnostics Liquid Biopsy Others

The core molecular diagnostic segment dominates the Middle East molecular diagnostics market due to the rising number of molecular testing in laboratories to cure diseases. Core molecular diagnostics applications include a large number of inclusive applications that cater to the major portion of the Middle East molecular diagnostics market.

Segmentation 5: by End User Hospitals Diagnostic Centres Outpatient Clinics/General Practitioners Research Laboratories Others

The hospitals segment dominates the Middle East molecular diagnostics market as hospitals, particularly in Middle East countries have incorporated extensive molecular diagnostics portfolios to provide superior care to patients suffering from diseases.

Segmentation 6: by Countryo Kingdom of Saudi Arabia (K.S.A.)o Israelo United Arab Emirates (U.A.E.)o Egypto Irano Qataro Other Countries

K.S.A. generated the highest revenue of $132.5 million in 2020. The Kingdom of Saudi Arabia (K.S.A.) has a huge population base suffering from various diseases and rising healthcare costs in the region. Medical research in the Kingdom of Saudi Arabia (K.S.A.) has gained momentum since 2013 and is heavily being invested in by the local government. The government is extensively supporting research organizations with projects aimed at improving the understanding and treatment of diseases affecting the Saudi population.

Recent Developments in Middle East Molecular Diagnostics Market

In January 2022, Abbott showcased its life-changing diagnostic tools and medical devices product portfolio for point-of-care testing (POCT) that helped COVID-19, diabetes, and cardiovascular disease patients at MEDLAB Middle East. In June 2021, biomeruix launched EPISEQ SARS-COV-2 to identify SARS-CoV-2 variants using samples from COVID-19 positive patients. In 2021, the BD. company declared the approval of the BD Veritor At-Home COVID-19 Test for the detection of SARS-CoV-2 with definitive digital results at home. In 2020, Bio-Rad Laboratories, Inc. partnered with Seegene, Inc., a Middle East leader in multiplex molecular diagnostics, for the commercialization and clinical development of molecular diagnostic products.

Demand Drivers and Limitations

Following are the demand drivers for the Middle East Molecular Diagnostics Market: Increasing Prevalence of Infectious Diseases and Various Types of Cancer in the Middle East Increase in Awareness and Acceptance of Personalized Medicines in the Middle East Significant External Funding for Executing Research and Development Exercises

The market is expected to face some limitations too due to the following challenges: Uncertain Reimbursement Scenario Lack of High-Complexity Testing Centers in the Middle East

How Can This Report Add Value to an Organization?

Product/Innovation Strategy: Major manufacturers of the Middle East molecular diagnostic market, along with the service providers, are actively involved in undertaking significant business strategies to translate success in research and development into the commercial clinical setting.

Growth/Marketing Strategy: Owing to the explosion of massively parallel sequencing and its applications, all areas of medicine have been affected, particularly molecular diagnostics.PCR has gradually evolved from gel analysis to real-time PCR to, more recently, digital PCR.

In digital PCR, amplification of individual targets is done in picolitre to nanoliter volumes, and instead of standard curves or internal controls, statistics are employed to calculate target concentrations.Genome-wide studies have gone beyond unknown expeditions, and disease association studies that use the expression, single nucleotide polymorphism, and copy number microarrays have identified useful markers that have been reduced to practical molecular tests.

Big data needs have resulted in new bioinformatics tools that continue to evolve rapidly.

Competitive Strategy: Key players in the Middle East molecular diagnostics market analyzed and profiled in the study have been involved as the Middle East molecular diagnostics-based product manufacturers that provide software and molecular diagnostic services.Moreover, a detailed competitive benchmarking of the players operating in the Middle East molecular diagnostics market has been done to help the reader understand how players stack against each other, presenting a clear market landscape.

Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.

Key Market Players and Competition Synopsis

The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration.

Some of the prominent names established in this market are: Abbott Agilent Technologies, Inc. bioMrieux SA BD Babirus Medical Equipment LLC Bio-Rad Laboratories, Inc. Danaher F. Hoffmann-La Roche Ltd. Guardant Health Illumina, Inc. QIAGEN N.V. Thermo Fisher Scientific Inc.

Countries Covered K.S.A. Israel U.A.E. Egypt Iran Qatar Rest-of-the-Middle EastRead the full report: https://www.reportlinker.com/p06284299/?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 Middle East molecular diagnostics market is projected to reach $1,017.7 million by 2031 from $493.1 million in 2020, at a CAGR of 6.72% during the...

When Alzheimers disease was believed to be caused solely by the accumulation of amyloid protein in the brain, pinning all hopes on an amyloid-targeting drug like Aduhelm the first drug approved to treat Alzheimers in 17 years made sense. But newer knowledge that ties Alzheimers to the biology of aging indicates the disease is caused by a combination of age-related changes in the brain that affect different people in different ways.

That means neither Aduhelm nor any anti-amyloid drug on its own will be a cure for the estimated 6.2 million Americans living with Alzheimers. The next phase of research must focus on promising drugs that target a host of underlying pathologies that contribute to Alzheimers.

Today more than ever, research is embracing this new understanding, taking a more diversified multiple shots on goal approach to new drug targets. More than three in four treatments currently in clinical development work against non-amyloid targets. These include drugs to reduce inflammation in the brain, improve blood flow, clear misfolded proteins, improve how the brain metabolizes energy, and more.

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To complement these pathways, new biomarkers are needed that will give physicians like me the tools needed to zero in on the causes of each patients Alzheimers and tailor combinations to provide precision personalized medicine.

Alzheimers research is notoriously challenging and expensive, outstripping cost estimates for research in most other therapeutic areas. The brain is incredibly complex, and while Alzheimers is the most common cause of dementia, it is not the only one. But Im more optimistic than ever about whats coming down the pipeline because Alzheimers research has moved into a modern era, not only in the breadth of its targets but in its ability to implement more rigorous clinical trials that track and determine the relationship between biomarker and clinical outcomes.

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If Aduhelm and other anti-amyloid antibodies that follow it are, at best, just one incremental piece of the puzzle, how do the blanks get filled in? For a start, it is time for everyone in the Alzheimers ecosphere to look toward a broader and more diverse approach to curing this devastating disease and speed the development of new, effective therapies to treat and prevent Alzheimers disease and related dementias.

A critical driver of better and faster clinical trials are biomarkers objectively measurable biological and behavioral characteristics that correlate with Alzheimers disease that are essential for improving trial design and quickly advancing the current pipeline of novel targets.

Biomarkers are already being used to great effect in early-stage trials, quickly telling researchers whether an experimental drug is engaging with its intended target in the brain. They are also playing a larger role in later-stage trials, providing better and quicker ways to screen and enroll patients whose Alzheimers disease profile includes the characteristic the experimental drug is meant to work on, and then by providing an easy means for tracking the effects of treatment. Biomarker data from brain amyloid PET scans, for example, provided the primary data for Aduhelms Food and Drug Administration accelerated approval.

Biomarkers are also making their way into clinical practice. Physicians can now use tests of blood and cerebrospinal fluid to measure brain amyloid levels in people experiencing early signs of mild cognitive impairment or dementia. The day will soon come when a simple blood sample, retina scan, or even a smartphone app will be able to identify underlying causes of Alzheimers during a doctor visit, allowing for treatment to be matched to a patients unique pathology.

As more drugs are developed against a wide range of targets, biomarkers must play a bigger role than ever in clinical trials. Researchers worldwide are working toward validating additional blood and other non-invasive tests that can measure brain levels of everything from tau and other toxic proteins to biological indicators of neuroinflammation, synaptic malfunction, and changes in metabolism. These new biomarker tests will be essential for both clinical trials and clinical practice.

Alzheimers researchers need to work together to conduct more biomarker-powered exploratory trials to more quickly and effectively assess whether a drug has promise. By adopting best practices in designing exploratory trials, researchers and companies can be more confident in using their results to make the all-important go/no-go decisions about advancing drugs to larger, later-stage trials.

In 2019, the Alzheimers Drug Discovery Foundation (which I co-founded) and the Association for Frontotemporal Degeneration convened an advisory panel of experts to provide recommendations on ways to optimize the design and application of exploratory trials. The panels recommendations, published last year in the journal Neurology, are designed to improve trial designs and engage patients more efficiently. When it comes to clinical trials, participants are a limited resource, so it is vitally important, especially for rarer forms of dementia, that they are matched to the right trials and that these trials run as efficiently as possible so each patients involvement is valued and maximized.

Policies that support efforts to bring repurposed drugs to the market are also urgently needed. Repurposed drugs start with an advantage because some of the research, including essential information about safety in humans, has already been done. But they are hampered by the economic disadvantage of limited returns on investment.

The pressure from patient advocacy groups for the FDA to approve and for Medicare to cover Aduhelm a drug that was at best only going to have a modest incremental benefit reflects the understandable public hunger for new Alzheimers treatments. It also underscores the urgent need for better ways to get effective drugs to market for the millions living with Alzheimers.

Its encouraging to see broader consensus in the research community for the need to take fresh looks at the biology of aging. In a 2021 Alzheimers Clinical Trials report, the Alzheimers Drug Discovery Foundation analyzed the approximately 120 clinical trials underway that are tackling a variety of age-related pathways.

These efforts will open the doors to new breakthroughs and the kinds of combination therapies that have changed the lives of people with cancer, diabetes, HIV, and other diseases. At this pivotal moment, academia, industry, regulatory agencies, patient advocates, venture philanthropists, and others need to work together as a community to accelerate the move into this new era of treatment possibilities for people with Alzheimers.

Howard M. Fillit is a neuroscientist and geriatrician, the co-founder and chief science officer of the Alzheimers Drug Discovery Foundation, and a clinical professor of geriatric medicine and palliative care, medicine, and neuroscience at the Icahn School of Medicine at Mount Sinai. He reports having consulted for various pharmaceutical companies, including Alector, LifeWorx, Eli Lilly, Otsuka Pharmaceuticals, and others.

See the rest here:
It's time to move past Aduhelm and focus on a broader Alzheimer's drug pipeline - STAT

An estimated 90% of clinical trials centered on cancers fail, sending those potential oncological treatments either to the drawing board or the scrap heap. Each unsuccessful trial means billions lost in R&D investment and, potentially, countless lives.

During this years BIO International Convention (taking place June 13-16 in San Diego), a group of industry professionals will share with attendees reasons why it doesnt have to be that way. Matthew Clark, board member and advisor with CerFlux, is one of the panelists speaking during Cancer Trials Dont Have to Fail 90% of the Time. Seriously, scheduled at 11 am PDT on Wednesday, June 15; Outsourcing-Pharma recently connected with Clark to learn about the session, and how cancer-centered trials might be able to improve their prognosis.

OSP: Could you please share your thoughts about the high failure rate of cancer trials, and how that proportion has changed over the years?

MC: One of the clearest presentations of this data from 2004 through 2015 is a study by Wong and colleagues in 2019 that indicated a 3.4% probability of success for oncology development efforts. Their research also revealed that over the last twenty years there has been little change in the probability of success of clinical trials as they vacillated around 5%.

The most recent results published by BIO last year showed a roughly 5.4% likelihood of success from preclinical to FDA approval for cancer treatments. This reveals that in terms of outcomes there is little improvement over the last 20 years.

OSP: In a nutshell, what are some of the reasons (big and small) for that high rate?

MC: There are numerous reasons for this high failure rate. Ill highlight only a few that require our attention. Perhaps the biggest reason is that cancer involves many variables involving heterogeneous populations and disease presentations. This conclusion is further evident from the consistently low failure rate of clinical trials prior to approval (90-98% failure) over more than a decade and the low probability of successful therapy (<25%) from FDA-approved therapeutics. This suggests that we consistently choose a target for therapy that cannot be demonstrated via traditional clinical trials.

Another reason related to multivariate factors in clinical trials for cancer pharmaceutical developments includes challenges with inclusion criteria for clinical trial participants. Simply put, the clear suggestion is that we are not testing the right products, focused on the right factors or outcome variables for clinical benefit, in the right populations or models, at the right time prior to going to clinical trial. We have to remember that clinical trials should be demonstrations of clinical utility rather than exploratory in nature or purpose.

OSP: What kinds of solutions might pharma companies and their research partners have tackled in the past to try and bring that number down?

MC: Biomarkers are perhaps the focus of the greatest push over the last nearly 20 years in the pharmaceutical industry. Most pointedly, there is a focus on omics to identify appropriate biomarkers. These approaches include proteomics, genomics, and metabolomics, to name a few, and are developing towards multi-omics.

Since the early 2000s, the argument has been that they can make a big difference, particularly when combined with existing techniques. The method is effective for exploratory research but has not produced the consistent results needed for the traditional groups-based designs generally used in clinical trials.

Similarly, cell-line-derived xenografts, patient-derived xenografts, and genetically modified animal models have generated lots of excitement because they attempt to mimic complex microenvironments or biological processes leading to or promoting cancer. These methods are expensive, time-consuming, and ultimately serve as a model that may not generalize back to the human disease state.

Unfortunately, the success of all of these approaches is less than clear as indicated by the consistently low probability of success or likelihood of approval at around 5% for more than 20 years. These efforts may have potential in the preclinical and exploratory arena, but to date, they have had little value in clinically relevant, therapeutic pharmaceutical development in the aggregate.

OSP: How can personalized medicine help elevate oncological drug development?

MC: A primary goal of personalized medicine is to tackle the heterogeneity of cancer directly. At the core, cancer is personalized, so the treatment of cancer must likewise be personalized.

However, the strategies for clinical success generally require group-based designs. This means the goal is to use individual responses to both the disease and possible therapeutics to identify the factors or biological processes at the right time allowing for better targets for therapeutic development that are not only effective but also have fewer side effects.

Through personalized medicine, we can take a more refined and nuanced approach to the treatment of different cancers that manifest in categorical and specific ways that treat the factors evident for a subgroup of those with the disease. Focused development will lead to more focused and more effective drug indications.

Done effectively, we believe that personalized medicine can further reduce the costs and time of drug development by elucidating what factors matter when in the progression of the disease. Therefore, personalized medicine can reduce the noise that historically plagued the development of drugs for cancer ultimately upending the vast majority of clinical trials.

We believe that with personalized medicine we can address the variability inherent in cancer by better identifying and aligning the idiosyncratic and temporal aspects of cancer with the concomitant treatments that are required; essentially, synchronizing the variability in cancer with the array of therapeutic formulations like two overlapping sine curves instead of interference from being out of phase.

Another outcome of personalized medicine is that it can help reduce hesitancy to participate in clinical trials through better target selection concurrently with off-target identification. It also will improve inclusion criteria, endpoint selection for trials, clinical trial planning, and decrease the cycle time for trials to enroll and complete. Each of these is a challenge to the development of cancer therapeutics that personalized medicine can improve.

OSP: How can companies like yours help drug development pros harness PM to put their cancer treatment candidates on a more favorable path?

MC: The hallmark of the CerFlux platform is providing a preview of clinical response well in advance of clinical development through ex vivo screening and analytics of drugs, or combinations of drugs, directly against actual tumor biopsy. Such previews could vastly improve productivity and returns by redirecting investment in more productive assets early and also improve patient outcomes.

Screening directly against tumor biopsies allows us to evaluate and better appreciate the heterogeneity and complexity of cancer in relevant ways that should be predictive of clinical outcomes. For instance, directly analyzing patient tumor biopsy avoids distortion of tissue composition and microarchitecture resulting from dissociation or expansion. Further, since core biopsies are standard of care for many solid tumors, such evaluation would add minimal burden on patients and clinical care teams.

Finally, assessment of standard of care biopsies would also mitigate racial and ethnic biases. This would allow pharmaceutical companies to better target their limited resources on drugs that are likely to have a higher probability of success on a broader population while further reducing the probability of negative side effects. Of course, our approach will not be a panacea, but we believe that it will be a notable improvement over the current approach that is clearly not working. Over time, iterative and incremental improvements through our process will help people find ways to live productive lives with cancer.

OSP: Do you have anything to add?

MC: Thank you for the opportunity to share our perspective and how we are trying to motivate change in this important area. The more we transparently challenge ourselves to be better, the greater the opportunity to partner for solutions that make a difference for thoseliving with cancer.

The BIO International Convention is scheduled June 13-16 at the San Diego Convention Center. Visit the show website for more information or to register.

More here:
Can the industry elevate the success rate of cancer trials? - OutSourcing-Pharma.com

"At Illumina, customers are at the center of what we do, and we are excited to connect with them at AGBT to unveil our next-generation genomics solutions and learn more about their specific needs and requirements," said Susan Tousi, Chief Commercial Officer at Illumina. "AGBT represents a key opportunity for Illumina to continue driving innovations that accelerate personalized medicine far into the future with our many valued partners."

New, longer-read kit configurations

Expected to be released later this year, the new 600 cycle kit on NextSeq 1000/2000 will deliver longer, paired-end 2x300bp reads and expand the breadth of applications ranging from metagenomics to immune-repertoire profiling. Data will be presented demonstrating NextSeq 2000 as a powerful, new tool to enable full-length V(D)J immune repertoire sequencing at scale to further understand the human immunome.

"The upcoming launch of our new NextSeq kits is another important step towards continuing to elevate sequencing to a new industry benchmark," said Alex Aravanis, SVP and Chief Technology Officer at Illumina. "Greater gene sequencing depth and length, combined with advanced library preparation approaches, represent the next wave of technological advances in repertoire sequencing that will unlock the power of the genome to transform human health."

New data with Infinity Technology

In its June 8 session entitled "Emerging Applications and Advances in Whole Genome Sequencing," Illumina will share new data from its Infinity technology platform, demonstrating exceptional performance across difficult-to-map regions of the genome, the ability to resolve complex structural variants, and the functionality to generate phased data across the highly polymorphic human leukocyte antigen (HLA) regions to assign haplotypes. Additionally, Illumina will share data using the Infinity technology in combination with targeted enrichment. This approach allows users to target the approximately 5% of difficult-to-map genic regions in combination with a standard Illumina genome to enable unprecedented scale using a novel and cost-effective approach.

The Ashley Lab at Stanford University has been an early collaborator with Illumina and has used Infinity data to analyze patient samples to further resolve the underlying genetic variation creating another powerful tool for more informed clinical decision-making to improve patient outcomes. Euan Ashley, MD, PhD, Professor of Genomics and Precision Health, Stanford University School of Medicine, presented data generated from Infinity technology in his keynote address at AGBT on June 6.

Optimized WGS performance with NovaSeq 6000 and best-in-class informatics

Illumina's NovaSeq 6000and DRAGEN Bio-IT platform are addressing some of today's biggest global health challenges, including genetic disease diagnosis, cancer detection and treatment, and global pathogen surveillance. Illumina's recent progress in informatics is also optimizing human WGS analysis.

In a June 9 session entitled "Connecting Samples to Genomic Analysis & Interpretation," Illumina will discuss its suite of informatics solutions and highlight its game-changing applications, including DRAGEN v3.10, which provides the most accurate measurement of the genome as measured against Precision FDA benchmarks. In an updated comparison, DRAGEN outperformed all other technologies across all benchmarks and in the difficult major histocompatibility complex (MHC) region. DRAGEN v3.10 continues to deliver industry-leading accuracy across numerous population-scale studies, such as All of Us, Genome England and UK BioBank.As of March 2022, Illumina's customers have processed more than 1.8 million whole genomes through the DRAGEN tools to accelerate the data processing component of sequencing.

Convening and leading critical conversations at AGBT

Illumina will convene and drive critical conversations around genomics innovation, foster industry collaboration, and discuss advances in its genomics technologies through a number of events and discussions at AGBT, including:

"At Illumina, we are pushing genomic technologies to new frontiers to solve the world's biggest health challenges," said Aravanis. "Through our involvement in this year's AGBT, we look forward to engaging with leading genomics innovators and thinkers about the next-generation genomics solutions that are driving the future of personalized medicine and the ways we can scale these critical innovations to transform health outcomes around the world."

Use of forward-looking statements

This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing, manufacturing, and launching new products and services, including expanding or modifying manufacturing operations and reliance on third-party suppliers for critical components; and (ii) legislative, regulatory and economic developments, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more,visitwww.illumina.comand connect with us onTwitter,Facebook,LinkedIn,Instagram, andYouTube.

Investors:Salli Schwartz858.291.6421[emailprotected]

Media:Adi RavalUS: 202.629.8172[emailprotected]

SOURCE Illumina, Inc.

Read more here:
Illumina Announces Next Generation Products and Data at AGBT General Meeting to Advance Innovative Customer Solutions - PR Newswire

WEST LAFAYETTE, Ind. Collaboration among Purdue University, Purdue Polytechnic Institute and Purdue University Global is leading the way to a unique partnership with the University of Puerto Rico.

A Purdue delegation of administrators, faculty and students visited Puerto Rico in March to meet with representatives and students fromfour University of Puerto Rico (UPR) campuses Bayamn, Humacao, Mayaguez and Rio Piedras as well as the Center for Marine Science at UPR-Mayaguez and the University of Puerto Rico Hospital.

The entire Purdue system is pleased to partner with the University of Puerto Rico to explore the creation and offering of new academic opportunities in an innovative fashion that serves both current and future workforce development needs, saidMelissa Burdi, Purdue University Global vice president and dean of the School of Nursing, who was part of the delegation. UPR is a highlyvalued partner, and we look forward to a dynamic and meaningful collaboration.

In a joint statement, Miguel Vlez-Rubio, chancellor for UPR-Bayamn, and Jorge F. Rovira-Alvarez, dean of academic affairs, said: The University of Puerto Rico at Bayamn is pursuing a strong collaboration partnership with Purdue University and its affiliates. We are confident that establishing agreements on diverse academic fields and services will allow both institutions to grow, and we foresee ample benefits for current students and future recruitment. It most definitively expands our academic offering and provides students with additional opportunities to develop both in professional areas and personal interests.

During the weeklong stay, Purdue students gave presentations on sustainability and climate change, biomedical innovation, emerging COVID technologies, mass migration at the U.S.-Mexico border and precision medicine and exchanged ideas with UPR students. They visited the Engine-4 coworking space, an incubator and the marine science laboratory in Mayaguez.

The focus was to forge relationships that willbenefit students and professors in disciplines such as precision medicine and health care, sustainability and climate change, and engineering. Specifically, the Purdue team initially identified three key areas to serve as a springboard for the partnership. They are:

Nursing: The Purdue University Global School of Nursing will collaborate with UPR to develop innovative education offerings and will invite nursing faculty from UPR to the Purdue West Lafayette campus for a Summer Institute to explore immersive learning virtual reality options for nursing faculty and students in Puerto Rico. Building this unique partnership affords the Purdue system and UPR the ability to co-create learning opportunities aimed at solving current and future workforce challenges within the entire health care ecosystem, where education and hands-on preparation are key, including the use of precision medicine, Burdi said.

With precision medicine, the goal is to utilize robots to disinfect critical areas in Puerto Rico hospitals while also detecting different contaminants in the hospitals air. During the COVID-19 pandemic, Purdue students worked with Luciano Castillo, theKenninger Professor of Renewable Energy and Power Systems in Mechanical Engineering at Purdue, and Richard Voyles, head of the Collaborative Robotics Lab at Purdue and director of the Robotics Accelerator, to design, build and deploy two autonomous cleaning robots to disinfect spaces.

Engineering: Purdue West Lafayette will develop a transfer program for UPR students to complete their degree in biomedical engineering and aerospace engineering. UPR-Bayamn is limited in the number of students accepted by UPR-Mayaguez into their existing programs. Additionally, this program will allow Purdue to grow its pool of diverse students in areas not offered at UPR-Bayamn, such as aerospace engineering, nuclear engineering, materials engineering and biomedical engineering. In collaboration with UPR faculty, Purdue faculty will develop a template for introductory courses. For Purdue to partner with the University of Puerto Rico to help them grow engineering programs, such as aerospace engineering and biomedical engineering, is a unique way to help grow the local workforce while increasing diversity here and promoting unique research partnerships such as Coastal Resiliency, said Mung Chiang, the John A. Edwardson Dean of the College of Engineering and Purdues vice president for strategic initiatives.

Professional development for police: UPR-Bayamn is the primary institution designated by the government to offer training opportunities for police. Purdue has identified a unique opportunity to leverage existing funding todevelop and offer high-quality professional development.

To jumpstart the partnership, UPR stakeholders have been invited to participate in the Summer Institute for Sustainability & Climate Change at Purdue West Lafayette from June 20 to Aug. 1.

Castillo is working with the Office of Naval Research (ONR) on a consortium for Historically Black Colleges and Universities and Hispanic-serving institutions to conduct this initiative with the goal of building and mentoring a diverse workforce that will solve future challenges pertaining to sustainability climate change, security and precision medicine. The target audience is K-12 students and faculty and college undergraduate and graduate students, and participants will receive a certificate of completion after taking part in the monthlong institute.

Addressing social inequality and engaging the untapped talent in our communities while solving climate change, health challenges, and security are major goals of our consortium, Castillo said. By increasing a diverse STEM workforce, we will accelerate new innovations, which will propel a strong economy in Puerto Rico, specifically in disadvantaged communities. For us to partner with the University of Puerto Rico to address problems related to coastal resiliency, renewable energy and train a strong STEM workforcewill help us build a vibrant future for the island and in the mainland.

About Purdue University

Purdue University is a top public research institution developing practical solutions to todays toughest challenges. Ranked in each of the last four years as one of the 10 Most Innovative universities in the United States by U.S. News & World Report, Purdue delivers world-changing research and out-of-this-world discovery. Committed to hands-on and online, real-world learning, Purdue offers a transformative education to all. Committed to affordability and accessibility, Purdue has frozen tuition and most fees at 2012-13 levels, enabling more students than ever to graduate debt-free. See how Purdue never stops in the persistent pursuit of the next giant leap athttps://stories.purdue.edu.

About Purdue Polytechnic Institute

The Purdue Polytechnic Institute, one of the 10 academic colleges of Purdue University, provides a unique array of high-demand technology disciplines for bachelors, masters and Ph.D. degrees available on Purdues flagship campus in West Lafayette, Indiana, and at other locations throughout the state. The Polytechnics faculty and staff encourage innovation, collaboration and creativity among diverse interdisciplinary groups in the persistent pursuit of big ideas and novel approaches. Thanks to our generous alumni and engaged industry partners, Purdue Polytechnic continues the important steps of Purdues history, preparing our graduates for their successful futures.

About Purdue University Global

Purdue University Global delivers personalized online education tailored to the unique needs of adults who have work or life experience beyond the classroom, enabling them to develop essential academic and professional skills with the support and flexibility they need to achieve their career goals. It offers personalized paths for students to earn an associate, bachelors, masters or doctoral degree, based on their work experience, desired pace, military service, previous college credits and other considerations no matter where they are in their life journey. Purdue University Global is a nonprofit, public university accredited by the Higher Learning Commission. It is affiliated with Purdue Universitys flagship institution, a highly ranked public research university located in West Lafayette, Indiana. Purdue University also operates regional campuses in Fort Wayne and Northwest Indiana, as well as serving science, engineering and technology students at the Indiana University-Purdue University Indianapolis (IUPUI) campus. For more information, visit purdueglobal.edu.

Media Contact: Tom Schott, tschott@purdue.edu

Sources: Mung Chiang

Maricel Lawrence

Melissa Burdi

Luciano Castillo

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Purdue Polytechnic Institute and Purdue University Global collaborating on partnership with the University of Puerto Rico - Purdue University

NEW YORK--(BUSINESS WIRE)-- Massive Bio, Inc., a leader in precision medicine and artificial intelligence (AI)-enabled patient-centric clinical trial enrollment for oncology, and AdhereTech, a pioneer and leading provider of smart devices that connect patients to care with real-time interventions, announced their partnership to provide advanced, data-driven digital health technology solutions, focusing in oral oncolytic agents providing real-time integrated access to care for cancer patients to precision oncology drugs and leading-edge clinical trials. Both companies were recognized in the 2022 NYC Digital Health 100 which showcases the most exciting digital health companies in the New York region.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220607005289/en/

Massive Bio and AdhereTech, two of NYC Digital Healths 100 most promising start-ups, announce a partnership to provide integrated access to precision oncology care for cancer patients. (Photo: Business Wire)

Massive Bio and AdhereTech have committed to combining their products and services to offer global, comprehensive solutions to measure, analyze and monitor precision oncology medication adherence for patients participating in clinical trials and those prescribed commercially available treatments. Both companies currently are contracted with leading pharmaceutical companies and major specialty pharmacies. Their work with payers, pharmacies and pharmaceutical companies to develop adherence programs utilizing device generated data to optimize processes and improve cost-effective measures for specialty drug and clinical trial programs that may save the industry hundreds of billions of dollars per year.

While the conversation around digital health and pharma has expanded well beyond from adherence, in oncology it provides the link between cost-effective treatments, and an opportunity to prioritize clinical trials when most appropriate mentioned Selin Kurnaz, CEO and Co-Founder of Massive Bio. Even modest improvements can lead to huge cost savings for payers and the pharmaceutical research industry, while allowing streamlined access in real time to effective on-label precision oncology treatments. It is a win-win situation for all stakeholders, from patients to specialty pharmacies, payers, and the commercial and cancer research ecosystem. AdhereTech is one of the few companies that is successfully achieving those goals, and we are excited about this collaboration.

With over 13,000 active cancer clinical trials in the US at any given time, and dozens of biomarkers and precision oncology molecules under study, Massive Bio aims to use AI and patient-centric concierge services at scale to reach cancer patients globally and accelerate the oncology research and development infrastructure. Massive Bio had recently announced the launch of its NASA-style Oncology Clinical Trial Command Center (OCTCC) to disrupt and accelerate trial enrollment, and also the launch of its 100K Cancer Clinical Trial Singularity Program aimed at matching 100,000 cancer patients in real-time to cutting-edge clinical trials using its Massive Bios AI-based technology, website and apps across iOS and Android platforms, expanding their presence as a global company with country-level success in 12 markets.

AdhereTech is a leader in medication programs, providing commercialized digital solutions to measure and manage medication adherence in a variety of settings, including academics, clinical trials, and commercially prescribed treatments. It develops and produces treatment management solutions utilizing smart devices with integrated cellular technology that, seamlessly, connects patients in real time to confirm when patients take their medication and provides two-way communications to ensure dosing regimens are followed and reports and escalates the reasons for and missed doses.

The Aidia System creates personalized patient support with specialty pharmacies and healthcare teams, enabling timely health interventions when they are necessary, and clinical trials can benefit from those key interventions, said Chris OBrien, Chief Executive Officer of AdhereTech. Upon learning of Massive Bios traction in the oncology space, and the opportunities of using our Aidia System, expansive network, and real-world data to help patients, physicians and the cancer research industry at a technology enabled scale, it made absolute sense to explore and operationalize this partnership.

Our AI-enabled clinical trial and precision oncology therapy-finding technology works at its best when paired up with real-time patient-reported insights said Arturo Loaiza-Bonilla, M.D., Co-Founder of Massive Bio. By leveraging real-time data from AdhereTechs Smart Adherence System in combination with our SYNERGY-AI cancer trial matching platform, we can identify key opportunities for clinical trial enrollment, while also optimizing medication adherence and access in both precision oncology care, and cancer research.

At AdhereTech, we strive to bring data, analytics and new technologies to market to serve patients and life science companies with better resources in the vital clinical research and treatment realms said Gregory Gallo, Chief Revenue Officer of AdhereTech. Were excited to partner with a cutting-edge solutions provider in the critical oncology therapeutic category. Collaborating, integrating technology and resources will serve to streamline patients journeys and achieve more consistent engagement, enhance care and ultimately improve outcomes and scientific advances, added Gallo.

About AdhereTech

AdhereTech is a privately held digital health company headquartered in New York, NY, and is the leading provider and pioneer of smart devices that connect patients to care via real-time interventions. AdhereTech partners with pharmaceutical manufacturers, specialty pharmacies and healthcare teams with the mission of using technology informed by insights into human behavior to improve health outcomes. Its Aidia SystemTM is a proven, integrated technology-based adherence solution that empowers patients and healthcare teams to achieve optimal medication success. For more information, please visit us at http://www.adheretech.com. You can also follow us on LinkedIn and Twitter, @AdhereTech.

About Massive Bio

Massive Bios (https://massivebio.com/) mission is to provide access to clinical trials for every cancer patient regardless of his/her location and/or financial stability. Massive Bio is an AI-driven platform connecting cancer patients and their oncologists to bio-pharmaceutical clinical trials, yielding profound improvement in access and match rates, leading to faster drug development timelines, and creating a novel oncology data ecosystem for improved protocol design and real-world insights. Massive Bio controls the patient enrollment value chain starting with patient identification, following with AI-based virtual pre-screening outside the site, and resolving last mile issues for clinical trial enrollment. While improving cancer patients lives, Massive Bio serves over two dozen pharmaceutical companies, contract research organizations (CROs) and hospital networks. In addition, Massive Bio has been awarded an SBIR contract by the National Cancer Institute (NCI) to develop and characterize its Deep Learning Clinical Trial Matching System (DLCTMS), Contract No. 75N91020C00016. Selected to the "Digital Health 100" by New York City Health Business Leaders, Massive Bio provides oncology dedicated patient recruitment, site selection, real-world data services, and AI-based trial prescreening services to its enterprise customers. Massive Bio was founded in 2015, is headquartered in NYC, and is privately funded by strategic and financial investors. Follow Massive Bio on Twitter, LinkedIn, and Facebook.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220607005289/en/

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AdhereTech and Massive Bio, Two of NYC Digital Health 100 most Promising Start-Ups, Announce AI-Enabled, Patient-Centric Oncology Solutions...

DCISionRT with Novel Residual Risk Subtype Identifies Patients Who May Not Benefit from ET after Surgery and Radiation

LAGUNA HILLS, Calif., June 7, 2022 /PRNewswire/ -- Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, announced compelling results in 926 women diagnosed with ductal carcinoma in situ (DCIS). The new information was presented in an oral abstract session at the American Society of Clinical Oncology (ASCO) Annual Meeting at McCormick Place, Chicago, IL.

The results of the study demonstrated that after breast conserving surgery (BCS) patients in the DCISionRT elevated risk group had a significant risk reduction from endocrine therapy (ET), while those patients in the DS low risk group did not have a significant risk reduction from ET.

"For the first time, physicians have access to an enhanced method of identifying which patients may have a significant or minimal benefit from adjuvant endocrine therapy based on individual tumor biology," said Pat Whitworth, MD, FACS, ASCO Presenter and Breast Surgical Oncologist Director, Nashville Breast Center; Associate Professor, University of Tennessee; and Managing Partner TME. "The results are meaningful and support a more tailored treatment plan for our DCIS patients."

DCISionRT stratified patients as low risk, neither adjuvant ET nor radiation therapy (RT) resulted in reduced 10-year ipsilateral breast recurrence (IBR) (5.6% BCS+ET vs BCS alone). Patients in the elevated risk group, benefited from adjuvant ET as well as RT.

"We are excited to share this unique data demonstrating the expanded utility of DCISionRT to guide personalized treatment decisions for DCIS patients," says Dan Forche, President and CEO of PreludeDx. "As precision medicine becomes the new standard of care, we are committed to continuous innovation to improve healthcare outcomes for early-stage breast cancer patients, clinicians and the healthcare system."

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman's individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Scorethat identifies a woman's risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT's intelligent reporting provides a woman's recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.

About PreludeDx

PreludeDx is a leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from University of California San Francisco, PreludeDx has focused on developing precision breast cancer tools that will impact a patient's treatment decision. Our mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden to the healthcare system. Before making a treatment decision, Know Your Risk. PreludeDx is a Fjord Ventures portfolio company.

For more information on how PreludeDx is making a difference for patients, please visit the Company's website: https://preludedx.com and follow us on Twitter @PreludeDx, Facebook, Instagram and LinkedIn.

PreludeDx, the PreludeDx logo, DCISionRT, the DCISionRT logo, Decision Score, The DCIS Test, Know Your Risk and Your Biology, Your Decision are trademarks of Prelude Corporation or its wholly owned subsidiaries in the United States and foreign countries.

Media Contact

Investor Contact

Cory Dunn

Andrew Wade

760.705.7464

949.600.8925

cdunn@preludedx.com

awade@preludedx.com

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SOURCE PreludeDx

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PreludeDx Presents New DCISionRT Data on the Effectiveness of Endocrine Therapy in DCIS Patients at the ASCO 2022 Annual Meeting - 69News WFMZ-TV