StemCell Therapy

Ever since the coronavirus was identified by Chinese officials in early January, news reports have alerted us to its escalation on an almost hourly basis. With over 4,000 cases in China, 106 of which have proved fatal, new outbreaks of the virus have since been confirmed in Australia, Canada, France and Germany. A respiratory infection similar to SARS, the nature of the coronavirus means it has the potential to spread far and wide, and quickly.

If the virus is actually as contagious as is being currently asserted, modern air travel and the purported time of incubation and asymptomatic status (about two weeks) really means it can spread anywhere on the planet, says cardiologist and vitamin C expert Dr Thomas E. Levy. As with nearly all other contagious viruses, spread is most commonly due to airborne virus in microdroplets from sneezing, coughing and the exhalation of infected individuals.

A sensible first step? A strong immune system is really the only significant protection for an individual, says Dr Levy. And a great deal of immune system strength comes from the vitamin C content in the immune cells. When the levels of vitamin C in the body are low, the immune system can never function at full capacity, he adds. (To boost your natural defences try a daily dose of oral supplementation, anywhere up to 2000mg.)

Understandably, the possibility of a pandemic is enough to cause serious panic. While avoiding exposure to anyone likely affected is an obvious precaution, there are practical ways you can protect yourself and allay your worries. Here are Vogues tips to help you keep calm and carry on.

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Washing your hands frequently isnt just good daily etiquette, its the first line of defence when it comes to warding off the spread of infection. For the most effective results apply warm water to your hands before lathering up with your chosen soap Floriss Luxury Hand Washes make the job more enjoyable. Scrub vigorously for at least 20 seconds to kill any germs, making sure you reach every part including the backs of your hands and under your fingernails, then rinse well and dry. If the occasion means its impossible to get to running water, then a hand sanitiser will suffice; just ensure it contains at least 60 per cent alcohol, which is enough to get to work eliminating almost all classes of germ immediately. When it comes to mixing form and function, Byredos Rinse-Free Hand Wash, (25) does a sterling job: combining Scandi-chic packaging with breezy florals and soft musks, it makes pulling it out of your handbag every hour a pleasure, rather than a chore.

While you might be more familiar with the power of LED therapy when it comes to treating myriad skin ailments (everything from increasing collagen and bounce in the skin to fading acne scars), its also an effective tool in combatting feelings of stress and anxiety. Near-Infrared has a balancing effect on cortisol, which is commonly referred to as the stress hormone, while happy hormones like serotonin and dopamine are triggered by the lights, explains The Light Salon co-founder Laura Ferguson. Add to that the sensation of warmth that gently spreads over your skin for the duration of the treatment, and chances are youll re-emerge much more zen than you went in. Plus, of course, glowing, healthy skin is always a welcome bonus. For a quick but effective blast of bliss without even having to remove your make-up, book in for The Pick-Me-Up (35 for 15mins) at The Light Salon.

Read more: How To Survive A Hormone Crisis In Your Twenties

Meditation can play a key role in providing a sense of clarity and perspective during times of intense worry, something youll already know if youre one of the 40 million global users of the Headspace app. On a physical level, things like meditation, sound healing, reiki healing and breathwork kick in your parasympathetic nervous system, which is responsible for rest and relaxation, and tone down your fight or flight response, explains Yulia Kovaleva, Founder of Re:Mind Studio. To engage with this ancient relaxation technique, regardless of your experience or skill, Yulia suggests the simple step of connecting with your breath. Breathe in, collecting all the tension and tight feelings around your chest, and then exhale. Imagine it moving down through your body, down to your belly, into your pelvis and all the way down into your feet and leaving your body, releasing it into the ground. Best of all, the practice can be done anywhere and anytime, even (and perhaps aptly) on the Central line at 8am.

Not just a way to perk up your evening bath, aromatherapy has a proven impact on issues including depression and insomnia. As we breathe the essential oil, some constituents are absorbed through the nose via the olfactory bulb which communicates with the limbic system, says Annee de Mamiel, aromatherapist and skin practitioner. The limbic system is directly connected to those parts of the brain that control heart rate, blood pressure, breathing, memory, stress levels and hormone balance. Harness the potency by sprinkling a few drops of an inhalation blend inside a tissue; de Mamiels Altitude Oil (30) was created to help protect the immune system and contains linalool-rich lavender to relax the mind, and antiviral eucalyptus, pine and lemon myrtle to fight bacteria and viral pathogens.

Even if not directly affected by trauma, often the thought of perceived risk is enough to make us feel anxious. To set your mind at ease, enlist the help of an herbal tincture to soothe frayed nerves, re-establish a sense of equilibrium and sharpen brain function. Lauded in Ayurvedic medicine, studies have shown that ashwagandha, also known as Indian ginseng, is an adaptogenic herb (meaning it can help your body handle stress better) that can have a significant effect on fighting symptoms of anxiety by modulating cortisol. Try adding a teaspoon to your morning smoothie, or mixing with warm milk and honey before bed.

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5 Ways To Avoid Freaking Out About The Coronavirus - British Vogue

As the emerging Wuhan coronavirus outbreak dominates the daily news, you might be wondering just how the pathogen is working its way around the world. This virus travels from place to place by infecting one person at a time. Some sick people might not spread the virus much further, but it looks like some people infected with the novel coronavirus are what epidemiologists call super spreaders.

Elizabeth McGraw, the director of the Center for Infectious Disease Dynamics at Pennsylvania State University, explains just what that means and why super spreaders can be crucial to a diseases transmission.

Researchers currently estimate that a person carrying the Wuhan coronaviruswill, on average, infect approximately 2.6 people.

Recent reports out of Wuhan also cite a case of a single patient who infected 14 health care workers. That qualifies him as a super spreader: someone who is responsible for infecting an especially large number of other people.

During an emerging outbreak, epidemiologists want to determine whether super spreaders are part of the picture. Their existence can accelerate the rate of new infections or substantially expand the geographic distribution of the disease.

In response to super spreaders, officials can recommend various ways to limit their impact and slow the spread of disease, depending on how the pathogen is transmitted. Pathogens transmitted via air droplets, contaminated surfaces, sexual contact, needles, food or drinking water will require different interventions. For example, the recommendation for face masks would be specific to airborne transmission, while hand-washing and surface sterilization are needed for germs that can live for a while on surfaces.

Whether someone is a super spreader or not will depend on some combination of the pathogen and the patients biology and their environment or behavior at the given time. And in a society with so much global connectivity, the ability to move pathogens rapidly across great distances, often before people are even aware they are sick, helps create environments ripe for super spreading.

Some infected individuals might shed more virus into the environment than others because of how their immune system works. Highly tolerant people do not feel sick and so may continue about their daily routines, inadvertently infecting more people. Alternatively, people with weaker immune systems that allow very high amounts of virus replication may be very good at transmitting even if they reduce their contacts with others. Individuals who have more symptoms for example, coughing or sneezing more can also be better at spreading the virus to new human hosts.

A persons behaviors, travel patterns and degree of contact with others can also contribute to super spreading. An infected shopkeeper might come in contact with a large number of people and goods each day. An international business traveler may crisscross the globe in a short period of time. A sick health care worker might come in contact with large numbers of people who are especially susceptible, given the presence of other underlying illnesses.

There are a number of historical examples of super spreaders. The most famous is Typhoid Mary, who in the early 20th century purportedly infected 51 people with typhoid through the food she prepared as a cook. Since Mary was an asymptomatic carrier of the bacteria, she didnt feel sick, and so was not motivated to use good hand-washing practices.

During the last two decades, super spreaders have started a number of measles outbreaks in the United States. Sick, unvaccinated individuals visited densely crowded places like schools, hospitals, airplanes and theme parks where they infected many others.

Super spreaders have also played a key role in the outbreaks of other coronaviruses, including SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). A traveler sick with SARS and staying in a Hong Kong hotel infected a number of overseas guests who then returned home and introduced the virus into four other countries.

For both SARS and MERS, super spreading commonly occurred in hospitals, with scores of people being infected at a time. In South Korea in 2015, one MERS patient infected over 80 other patients, medical personnel and visitors in a crowded emergency department over a three-day period. In this case, proximity to the original patient was the biggest risk factor for getting sick.

Yes. Some scientists estimate that in any given outbreak, 20% of the population is usually responsible for causing over 80% of all cases of the disease. Researchers have identified super spreaders in outbreaks of diseases from those caused by bacteria, such as tuberculosis, as well as those caused by viruses, including measles, MERS and Ebola.

The good news is that with the right control practices specific to how pathogens are transmitted hand-washing, masks, quarantine, vaccination and so on the transmission rate can be slowed and epidemics halted.

This article has been updated to correct a typo concerning the disease Typhoid Mary spread.

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What is a super spreader? An infectious disease expert explains - The Conversation US

NIH research is working hard to solve the puzzle of how genes and lifestyle connect to affect our lives and our health. Today, researchers can scan and compare entire genomes very quickly. These studies have already turned up disease signatures for type 2 diabetes, heart disorders, prostate cancer, Crohns disease, Parkinsons disease, and age-related macular degeneration. More disease-related gene variants are identified every few months.

The Human Genome Project and thousands of follow-on studies are helping scientists to develop gene-targeted treatments. A poignant example is the case of a woman with lung cancer that had spread to her brain. Diagnosed in 2002, this 44-year-olda vegetarian who had never smokedunderwent various therapies to stave off what seemed inevitable. Then came a miracle: she learned of a clinical trial testing a new drug, getfitinib, that for some tumors appeared to work as a genetic smart weapon. Her tumor was one of those, and she is alive today because of medical research.

Thanks to NIH-funded basic research that gave us genetic engineering and launched the $40 billion biotech industry, DNA is a household name. Virtually every biomedical research lab and pharmaceutical company throughout the world uses the power of the genomic revolution every day to demystify diseases and find new cures. Within 5 years, the complete DNA instruction bookor whole genomeof an individual will read out for less than $1,000, making genetic analysis a routine part of medical care.

One recent study provides a glimpse of how whole-genome sequencing might eventually be used in the clinic. Scientists evaluated the entire genome of a 40-year-old man to determine his risk for dozens of diseases and his likely response to common drugs. They pinpointed gene variants linked to several diseases in the mans family, including vascular disease and early sudden death. They also found variants linked to conditions not known to be in his family, such as thyroid and parathyroid diseases. Other gene variants predicted the patients likely responses to certain heart medicationsinformation thats especially relevant since hes at risk for cardiovascular disorders.

Remarkable advances in the field of pharmacogenomicshow individuals react differently to medicinesindicate that we are moving away from one-size-fits-all medicine. Scientists can now identify glitches in our DNA scripts that reveal what drugs may be dangerousor completely ineffectivefor certain people. This information will help doctors calculate precise dosages that match a persons DNA.

Collectively, research results in this important area of biomedicine are prompting the U.S. Food and Drug Administration (FDA) to consider changing the labeling requirements for important medicines taken by millions of Americans. Already, pharmacogenomic information is contained in about 10% of labels for drugs approved by the FDA to treat a range of conditions including HIV/AIDS, cancer, seizures, and cardiovascular disorders.

Next: Stem Cells

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Personalized Medicine | National Institutes of Health (NIH)

Say precision medicine and people think of personalized cancer treatment. But this innovation has already begun to revolutionize primary care tooeven though the jury is still out, in many cases, on whether it makes a clear difference in outcomes.

Just what precision (alias personalized) medicine is isnt always spelled out precisely. But usually it is discussed as prevention or treatment that takes into account individual differences among patients, most often genetic differences. Some people expand the concept to consider individual differences in environment and lifestyle.

In adult primary care, two subsets of precision medicine have attracted the most attention recently: predictive genetic testing and pharmacogenomics.

Predictive genetic testing is what it sounds like: A genetic test that forecasts a persons chance of getting a disease. The term is also applied to germline genetic tests that provide some indication of the predisposition being passed down to offspring. Proponents see predictive genetic testing for certain inherited conditions as a way to unearth risks in people who can then get early treatment or take preventive steps to head off serious and possibly costly conditions. Actor Angelina Jolie put BRCA testing as a predictive genetic test into the public consciousness with her announcement in 2013 that she underwent a double mastectomy after testing positive for a BRCA mutation.

Pharmacogenomics studies show how a persons genes can affect his or her response to medications. Ideally, pharmacogenomic (sometimes called pharmacogenetic) results could end some of the trial and error with drugs and help providers and patients choose the most effective drug right off the bat.

Where federal dollars are concerned, precision medicine has already stepped out of the cancer box. In 2015, President Barack Obama committed $215 million to precision medicine research, including a genomic study of more than a million Americans to extend precision medicine from cancer to other diseases. A year later, the 21st Century Cures Act expanded this funding to $1.5 billion over the next 10 years.

Aided by a multibillion-dollar genomic testing industry, some providers have started testing precision medicine beyond oncology. In 2018, Geisinger Health System in central Pennsylvania made a splash by announcing that it would add DNA sequencing to routine primary care. A small number of other hospitals are starting to monetize these tests. In August 2019, STAT reported that a handful of academic medical centers, including Brigham and Womens Hospital and the Mayo Clinic, have started elective genome sequencing clinics for generally healthy patients willing to pay hundreds, sometimes thousands of dollars in cash for a genetic workup.

Skeptics see carts preceding horses; solid evidence that routine genetic testing results in better outcomes is lacking. As one genome-sequencing clinic leader conceded in the STAT article, such testing can lead to expensive follow-up testing. Not surprisingly, payers have been reluctant to cover sequencing tests of various kinds.

Regulators have breathed life into some kinds of testing and poured cold water on others. Last year, 23andMe was the first testing company to get FDA approval to market a direct-to-consumer genetic test for three (of the more than 1,000 known) BRCA gene mutations linked to increased risk of breast, ovarian, and prostate cancer. But in April 2019, the agency issued a warning letter to Inova Health System in Northern Virginia to stop marketing pharmacogenomics tests it claimed could predict patients responses to antidepressants, opioids, and other drugs. The FDA said it was unaware of data to support these claims.

A survey published two years ago in Clinical Pharmacology and Therapeutics found that clopidogrel, a blood thinner, was the medication most commonly tested for a druggene interaction, followed by simvastatin and warfarin. Nearly 40 academic medical centers and community health systems testing ways to implement pharmacogenomics in clinical practice were surveyed.

Some evidence suggests that traditional screening methods may not identify everyone at risk for certain inherited conditions. In a study published in Science three years ago, researchers at Geisinger and Regeneron (which manufactures Praluent, a drug used to treat familial hypercholesterolemia) found that only about one in four people carrying the familial hypercholesterolemia gene variant met the Dutch Lipid Clinic Network criteria (widely used diagnostic criteria) for genetic testing. Still, evidence for the clinical utility of many pharmacogenomic or predictive genetic tests is pretty scanty at this point.

Right now, for the average primary care provider, there are a relatively limited number of situations where pharmacogenomic testing is clearly beneficial to outcomes in a way thats dramatic, says Greg Feero, MD, a faculty member at Maine Dartmouth Family Medicine Residency and a former senior advisor to the director of the NIHs genomics research division.

For predictive genetic testing, there are a few notable exceptionshereditary breast and ovarian cancer, Lynch syndrome, and familial hypercholesterolemiaif certain criteria such as family history of the condition are met. The CDC has designated genomics applications for these conditions as Tier 1, the highest tier on its evidence-based ranking system of genomic applications by their potential for a positive public health impact.

In a 2017 editorial published in American Family Physician, Vinay Prasad, MD, and Adam Obley, MD, of Oregon Health and Science University said that rigorous meta-analyses havent yet shown that genotype-guided dosing for warfarin, clopidogrel, or antidepressant selection is better than usual care. Prasad is a well-known critic of what he sees as the proliferation of medical treatments and therapies without good evidence behind them. We need to know on a broad scale that [these tests] improve outcomes for patients, and dont just reassure physicians theyre choosing a better drug, Obley tells Managed Care.

Prasad and Obley also argued in their editorial that without further proof of improved outcomes, routine genetic testing could just fuel more inappropriate care. Guidelines carve out clear boundaries for who should get tested because there are scenarios in which the risks and benefits of preventive measures arent known, they said, noting that the U.S. Preventive Services Task Force advises against genetic testing for BRCA mutations in women without a family history of BRCA-related cancers.

A small pilot study suggests that genetic testing in primary care may not lead to improved outcomes. In 2017, The Annals of Internal Medicine published the first randomized trial of whole-genome sequencing in primary care. Gene variants were found in 20% of the participants whose genomes were sequenced. But six months later none of them had improved outcomes.

The test produces lots of information, says Obley, who wasnt involved in the study. But its not clear that any patient was managed differently in a way that improved their health.

Without evidence supporting the clinical utility of routine pharmacogenomics or genetic testing, most payers are unwilling to cover them. Some exceptions exist, such as employers that offer routine genetic testing as an employee benefit. In a blog post published in 2018, Color Genomics touted Visa and the German software company SAP as customers. Medicare covers pharmacogenomic testing of two gene variants that predict warfarin responsiveness for beneficiaries enrolled in a randomized, controlled clinical study that meets certain standards.

The high cost of genetic testing has been cited as another reason insurance coverage is limited, but payers may not budge even as testing gets cheaper. The cost of doing the test itself has been declining quite rapidly, says Kathryn Phillips, a health economics professor at University of CaliforniaSan Francisco who researches personalized medicine access, quality, and reimbursement. She has disclosed in recent studies that she is a paid consultant for Illumina, a DNA sequencing company. But she says its hardand its going to take longerto figure out where to use genetics in primary care in healthy populations, and [for insurers] to pay for it.

The current state of evidence and bleak reimbursement prospects havent deterred early adopters from embracing precision medicine in primary care. For Megan Mahoney, MD, chief of general primary care at Stanford Medicine, precision medicine begins with going after data on key determinants of healthnot just genes, but also environmental factors, social determinants, and health behaviors.

In a yearlong pilot of 50 patientsmore than half of whom were at risk for cardiovascular conditionsStanford Medicine care teams created personalized care plans to prevent and manage chronic illness. The plans leveraged data from several sources, including genetic-risk assessments and genetic testing for the three CDC Tier 1 conditions and remote monitoring devices.

Before the pilot, which ended in 2018, Stanford did not offer routine genetic testing in primary care. So far, that hasnt changed. But Stanford is making the genetic-risk assessment tested in the pilot available to its primary care providers, hoping it can increase screening rates for the Tier 1 conditions, says Mahoney. Studies show that many primary care providers are uncomfortable evaluating and addressing genetic risk. Five patients in the pilot discovered through the genetic risk screening that theyre at high risk for breast cancer, demonstrating that this type of tool can help to identify previously unknown risks.

Post-pilot, Stanford is also offering patients with poorly controlled blood pressure connection to a Bluetooth-enabled blood pressure cuff and health coaching as part of a larger study. Genetic testing has dominated the discussion of precision medicine in primary care, but Stanfords experience shows that it isnt the only way to tailor preventive care to individual patients needs.

Even if clinical utility is ultimately shown, folding precision medicine into primary care will likely follow the path of many new developments in medicine: There will be some early adopters, but most practices will have a wait-and-see and depends-on-the-reimbursement attitude.

Educating doctors on how to interpret, use, and communicate genetic testing results to patients will be one of the biggest hurdles. Theyll be learning on the job, says Susanne Haga, associate professor of internal medicine at Duke Universitys medical school, who leads educational activities in genetics and genomics for the Duke Center for Applied Genomics. An obstacle course of other possible barriers awaits: the limited number of certified genetic counselors, concerns about privacy and genetic discrimination, and the potential for the lack of diversity in genomic data sets to exacerbate disparities in care.

Still, Haga sees the convergence of three factors that will force the health care systems hand and usher in precision medicine in primary care: patients increasing ability to influence decisions about their care, the declining cost of testing, and a critical mass of people, numbering in the millions, who will have had their DNA sequenced in genome programs such as Geisingers or several national genomics research initiatives.

Its coming, she says, one way or another.

Read more:
Precision Medicine in Primary Care: Bespoke. Genetic and Genomic. And Maybe Not Ready. - Managed Care magazine

Precision medicine promises a new paradigm in oncology where every patient receives truly personalized treatment. This approach to disease diagnosis, treatment and prevention utilizes a holistic view of the patientfrom their genes and their environment to their lifestyleto make more accurate decisions.

Growing at a rate of 10.7 percent, the precision medicine market is expected to exceed $96 billion by 2024.1 Bioinformatics represent a significant share of the market, as bioinformatics tools enable the data mining necessary for rapid identification of new drug targets and repurposing of existing treatments for new indications.1 (Reuters) The oncology segment of the precision market is expected to experience an 11.1 percent compounded annual growth rate (CAGR) leading up to 2024 due to the success of recent targeted therapies and subsequent high demand.

Still, precision medicine is in its infancy, and making personalized treatment a reality for all patients requires a transformation in how novel therapies are developed and delivered. New regulatory, technical, clinical and economic frameworks are needed to ensure that the right patients are able to access the right therapy at the right time. In this article, we review the current state of precision medicine in oncology and explore some of the challenges that must be addressed for precision medicine to reach its full potential.

Great strides toward precision medicine are being made in the area of cancer immunotherapy, which is designed to boost a patients own immunity to combat tumor cells. The introduction of immune checkpoint inhibitors (PD-1/PD-L1 and CTLA-4 inhibitors) revolutionized treatment for certain hematologic malignancies and solid tumors. To date, immune checkpoint inhibitors have been approved by the U.S. Food and Drug Administration (FDA) for more than 15 cancer indications, but their widespread use has been hampered by unpredictable response rates and immune-related adverse events.

The approvals of the first chimeric antigen receptor (CAR)-T cell (CAR-T) therapies in 2017 were the next leap forward in precision medicine. These immunotherapies demonstrated that it was possible to take out a patients own T-cells, genetically modify them, and then put them back in to target cancer cells. With complete remission rates as high as 83 percent within three months of treatment, CAR-T therapies represent a seismic shift in our approach to cancer, bringing the elusive possibility of a cure one step closer. However, longer-term follow-up has shown that these remissions may not be durable2 and prevention of relapse must still be studied.

Ultimately, the goal of cancer immunotherapy is to stimulate the suppressed immune system of a patient with cancer so that it can launch a sustained attack against tumor cells.3 This is complicated, as the interactions between tumors and immune systemsometimes called the Cancer-Immunity Cycle (see Figure 1 in the slider above)4are complex and dynamic. The Cancer-Immunity Cycle manages the delicate balance between the immune systems ability to recognize non-self and the development of autoimmunity.

In some cases, the immune system may fail to recognize tumor cells as non-self and may develop a tolerance to them. Moreover, tumors have an armamentarium of methods for evading the immune system. Given this elaborate interplay between cancer and immunity, there is a wide range of potential cancer immunotherapy approaches:

The immune response to cancer involves a series of carefully regulated events that are optimally addressed as a group, rather than individually.4 The complexity of the immune response to cancer provides a strong rationale for combination therapies, for instance:

Increasingly, the development and deployment of immunotherapy relies on harnessing genomic data to identify the patients most likely to respond to immunotherapy and to customize immunotherapy for a given patient.6 Thus, molecular profiling technologies, such as next-generation sequencing, have become integral to drug development and patient selection. At the same time, researchers are focusing on identifying molecular alterations in tumors that may be linked to response.7 The molecular fingerprints of a tumor can be quite complex and heterogeneous, not only across tumors, but also within a single patient. Consequently, molecular tumor characterization requires both multidimensional data from laboratory and imaging tests and advanced software and computational methods for analyzing these data.8 This emergence of computational precision oncology is associated with both opportunities and challenges, from validation and translation to regulatory oversight and reimbursement.

The regulatory landscape is evolving to keep pace with technological advances in cell engineering and gene editing. Since 2013, the FDA has published four guidance documents on cellular and gene therapy products, as well as two guidance documents providing recommendations on regenerative medicine advanced therapies (RMATs). Specifically, their Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, published in November 2017, provides guidance on the expedited development and review of regenerative medicine therapies for serious or life-threatening diseases and conditions. This document also provides information on the use of the accelerated approval pathway for therapies that have been granted the RMAT designation.9

In the EU, the European Medicines Agency (EMA) published a draft revision of its Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells in July 2018.10 This draft revision includes current thinking on the requirements for nonclinical and clinical studies, as well as specific sections on the scientific principles and clinical aspects of CAR-T products.

Precision medicines such as CAR-T therapies require manufacturers to transform a complex, individualized treatment into a commercial product. In conventional manufacturing, the entire manufacturing process occurs within the confines of the manufacturing facility. With cell therapies, however, the process begins with the collection of cells from the patient and ends with administration of the final product (see Figure 2 in the slider above). In between, the cells are handed off multiple times for the process of genetic modification, creating a complex supply chain that blends manufacturing and administration.11

Moreover, in contrast to traditional manufacturing where the starting materials are standardized or well-defined, the starting materials for cell therapies are derived from patients and, thus, highly variable.

As evidenced by the manufacturing challenges that plagued the launch of Kymriah (tisagenlecleucel), even pharmaceutical giants have struggled with meeting label specifications for commercial use.13 To help address its manufacturing hurdles, Novartis acquired CellforCure, a contract development manufacturing organization, and plans to transform by focusing on data and digital technologies.14,15 What this means for sponsors is that robust, scalable manufacturing must be incorporated into clinical developing planning at its earliest stages.

The high price tags associated with CAR-T therapies illustrate how expensive targeted therapies are in comparison to their traditional counterparts.16 Existing health insurance models have not been structured to reimburse for costly treatments that offer the potential for long-term benefit or even cure. The pricing model for CAR-T therapies may be especially challenging for private insurance companies, which have higher turnover and shorter coverage windows than national health insurance programs. For sponsors of precision medicine therapies, one way to address the challenge of reimbursement is to create innovative, value- or outcomes-based pricing models, rather than focusing on sales volume. The success of these new pricing models will rely on patient selection. To demonstrate value and optimizing outcomes, sponsors will need to develop profiles of patients who are most likely to respond and provide tools for identifying these patients.8

Of note, on August 7, 2019, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover FDA-approved CAR-T therapies when provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications. Medicare will also cover FDA-approved CAR-T treatments for off-label uses that are recommended by CMS-approved compendia.17

Beyond the pharmaceutical companies that are working to develop personalized treatments, the precision medicine ecosystem has a number of other key stakeholdersregulators, payers, diagnostic companies, healthcare technology companies, healthcare providers and, of course, patients. Pharmaceutical companies need to engage with each of these stakeholders by providing education or developing partnerships that help demonstrate the need for high-quality data collection, the value of precision medicine, and the process for identifying the right patients.

Sponsors may also benefit from engaging with patient advocacy groups as these groups play a critical role in connecting patients and caregivers with scientific and healthcare experts to learn about how new immunotherapy breakthroughs are changing the standard of care.

Empowered patients pushing for the latest innovations are propelling precision medicine forward, but we still have a way to go before the full potential of precision medicine is realized. In its maturity, precision medicine will not only enable the personalization of treatments for individual patients, but also inform public health at a population level as insights from the genetic and molecular data collected are used to advance our understanding of disease. Robust data collection and analysis, along with standardization, are required for building this foundation of precision medicine, and multi-stakeholder buy-in is necessary for addressing issues around data integration and privacy.

While significant challenges remain, the opportunity to transform patient outcomes and population health with precision medicine is tantalizing. Increasingly, we are seeing advanced technologiessuch as artificial intelligence and machine learningbeing incorporated into the drug discovery and development process. This underscores the critical need for a multidisciplinary approach to precision medicine, from discovery at the bench all the way through to delivery at the bedside, to help ensure that more patients can access the right therapy at the right time, and the right price.

References

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Realizing The Full Potential Of Precision Medicine In Oncology - Contract Pharma

Precision medicine, or personalized medicine as it is sometimes referred to, is a most significant and promising healthcare trend. The National Institutes of Health (NIH) defines precision medicine as an individualized plan that uses a patient's genetic makeup and their environment and lifestyle to deliver the right preventative advice or targeted disease treatment.

For example, precision medicine as it applies to cancer treatment might encompass:

The NIH has also started an ambitious research program designed to advance the study and applications involved in precision medicine, which can have positive ramifications for the future of medicine as a whole. The Precision Medicine Initiative is geared toward learning how genetics, environment, and lifestyle can help determine the best approach to prevent or treat disease.

Through the initiative, for example, scientists at the National Cancer Institute hope that further study of the disease's genetics and biology will lead to better life-extending treatments. The initiative's All of Us Research Program is also using the health data of approximately 1 million volunteers to study many other diseases, and improve prevention, diagnosis, and treatment stats.

Precision medicine has such a huge range of potential applications that the sky is literally the limit in terms of how it may help doctors treat virtually any disease in the future.

But right now, there are several exciting developments that you, as a physician or hospital administrator, should know about and investigate further to see if they may be appropriate for your patients' needs. These developments include:

The Centers for Disease Control has highlighted the fact that that a new small molecule drug, ivacaftor, is improving the outcomes of cystic fibrosis (CF) patients by closely targeting the specifics of why an individual patient has CF, as opposed to treating its symptoms.

Early administration of this therapy has greatly reduced the need for inpatient hospital stays and allowed patients to improve.

The CDC has also highlighted cascade screening, which means a healthcare team contacts the family members of patients with a range of conditions to interview them about and inform them about the hereditary implications of the illness they may all eventually deal with.

Then, patients who wish to be screened for genetic markers or a disease itself can do so. The information that doctors learn from a patient's relative can then be applied to treating the original patient. It's extremely important to take issues of consent and privacy into account in terms of this approach, but if done right, the benefits to patients and their families can be invaluable.

MD Anderson has set up a personalized care therapy resource website, through which any doctor can look up information on a diagnosed genetic marker and find cutting-edge info on clinical trials, disease mutations, and tumor profiling. Patients working with their doctors to better understand their conditions can use the website, too.

It's vitally important to keep up with precision medicine developments in your specialty fields and apply what is available for you as a physician or administrator right now. With precision medicine, you lengthen a patient's odds for a better outcome in so many potential ways. Just as important is that precision medicine can change the way your patients view their disease(s).

Lisa Mulcahy is an internationally established health writer whose credits include the Los Angeles Times, Redbook, Glamour, Elle, Cosmopolitan, Health, Good Housekeeping, Parade, Woman's Day, Family Circle and Seventeen. She is the author of eight best-selling books, including "The Essentials of Theater," an Amazon No. 1 new release.

Her Contemporary Authors biography is available here.

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New resources in precision medicine that every doctor should know about - MultiBriefs Exclusive

LEIPZIG, Germany and EMERYVILLE, Calif., Jan. 30, 2020 /PRNewswire/ --Profusa, a digital health company that is pioneering the next generation of personalized medicine, today announced research findings that suggest the company's Lumee Oxygen Platform may help improve the clinical management of patients with critical limb ischemia (CLI) who are undergoing endovascular revascularization treatment (EVT). The data, from a recent post-market clinical study called OMNIA (Oxygen Monitoring Near Ischemic Areas), were detailed in a series of presentations at the Leipzig Interventional Course (LINC) in Leipzig, Germany.

The Lumee Oxygen Platform is a tiny, injectable tissue-integrated biosensor with an intelligent data platform intended for continuous, real-time monitoring of tissue oxygen levels.

"Performing revascularization in patients with critical limb ischemia is standard practice, but the tools surgeons and interventionalists typically use to gauge effectiveness of the procedure are not ideal," said Marianne Brodmann, M.D., interim head of the Clinical Division of Angiology, Department of Internal Medicine, at Medical University inGraz, Austria. "These research findings from OMNIA suggest that continuously measuring tissue oxygen may result in better outcomes for these patients."

CLI is a serious form of peripheral artery disease (PAD), a condition that affects more than 200 million people worldwide and results in the narrowing of blood vessels and reduced blood flow to the lower limbs. Decreased tissue oxygen levels in the lower limbs of PAD patients can lead to disabled walking, or in more advanced cases, gangrene and amputation. CLI can result in severe pain in the feet or toes, even while resting.

OMNIA, a multicenter trial of the Lumee Oxygen Platform, monitored tissue oxygen levels in the affected limbs of 35 CLI patients who underwent EVT procedures, which are designed to clear obstructed arteries. Study participants were injected with four Lumee biosensors, three in the foot and one as a reference sensor in the arm. OMNIA collected measurements of oxygen throughout the revascularization process (with measurements performed before, during, and one, three, six, and twelve months post-procedure). OMNIA also recorded traditional hemodynamic metrics, including ankle-brachial index and toe-brachial index, and clinical assessments of wound healing at each follow-up visit.

The OMNIA data presented by Brodmann showed that increases in tissue oxygen during EVT were significantly higher in patients who experienced wound healing than in those who did not (p<0.01). In addition, tissue oxygen levels during revascularization were a better predictor of wound healing than traditional clinical measures, such as ankle-brachial index or toe-brachial index (p=0.59 and p=0.14, respectively).

"These findings show the importance of further investigating how continuous tissue oxygen measurements may satisfy an unmet clinical need to objectively evaluate how the increases in blood flow offered by EVT actually translate into nutritive oxygen delivery to the injured tissue," added Brodmann.

Martin Werner, M.D., an angiologist at Hanusch Hospital in Vienna, noted that traditional angiography during EVT does not sufficiently measure microvascular blood flow, a special concern for people with diabetes who may have microvascular impairment. He presented results of a retrospective classification analysis from OMNIA in which continuous oxygen traces measured by the Lumee Oxygen Platform were analyzed throughout EVT. Findings showed that oxygen changes between discrete time points, specifically start and end of EVT, may not be predictive of wound healing, but dynamic changes continually assessed throughout the procedure were.

"These results indicate that continuous measurements of blood flow in the foot during EVT may reveal factors that provide clues to treatment outcome that would have been missed if only measured at the start and end of the procedure," said Werner.

Stephen Kanick, Ph.D.,data science lead for Profusa, presented data from OMNIA that evaluated how Lumee biosensors assess long-term tissue viability following EVT treatments in patients with CLI. Results showed that patients who improved showed larger oxygen increases after EVT and maintained larger oxygen values at a three-month follow-up compared to patients who did not improve.

Miguel Montero-Baker, M.D., vascular surgeon and associate professor in the Division of Vascular Surgery and Endovascular Therapy at Baylor College of Medicine in Houston, discussed how tissue oxygen measured before, during and after EVT can be combined to provide a more accurate predictor of patient healing. According to Montero-Baker, "The Lumee Oxygen Platform gives us insights we have not had before about how CLI patients are responding to treatment."

"These findings from OMNIA affirm the emerging role of injectable biosensors in informing the treatment of patients with limb-threatening ischemia," said Ben Hwang, Ph.D.,chairman and CEO of Profusa. "Being able to monitor biochemical data such as tissue oxygen on a real-time basis may mean the difference between effective interventions and a catastrophic worsening of the condition."

Profusa's LumeeOxygen Platform and second-generation product, the Wireless LumeeOxygen Platform, are CE (Conformit Europenne) marked for use in the European Union. In the U.S., the Wireless Lumee Oxygen Platform is an Investigational Device limited by federal law to Investigational Use.

About ProfusaBased in Emeryville, Calif., Profusa is a digital health company led by visionary scientific founders, an experienced management team and a world-class board of directors who share the long-term goal of improving health and well-being for patients worldwide. With its long-lasting, injectable and affordable biosensors and its intelligent data platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians trust and rely upon. These data may allow people to act as an active and educated participant alongside their care team and understand how their choices and decisions impact health and well-being, day-in and day-out.

"LUMEE", "PROFUSA" and the PROFUSA logo are registered trademarks of Profusa Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia.

For more, visithttps://profusa.com.

AbouttheLumeeOxygen PlatformProfusa's first clinical offering, the LumeeOxygen Platform, and the next-generation Wireless LumeeOxygen Platform, which are CE marked for use in the European Union, are indicated for use in patients with potential acute and/or chronic changes in tissue oxygen levels who may benefit from monitoring. The Lumee Oxygen sensor provides an opportunity for continuous and long-term monitoring of oxygen changes in subcutaneous tissue. After a single injection, measurement thereafter is obtained non-invasively using an optical reader. In contrast to external pulse oximeters, which measure oxygen bound to the hemoglobin in larger blood vessels, the LumeeOxygen Platform measures dissolved oxygen at the tissue level in the fluid that bathes our cells.

Contact: Sylvia ArandaW2O pure424-201-9464saranda@purecommunications.com

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DUBLIN--(BUSINESS WIRE)--Jan 30, 2020--

The Molecular Diagnostics Market Share & Global Forecast, By Application, Technology, End User, Regions, Companies report has been added to ResearchAndMarkets.coms offering.

Increasing prevalence of Infectious diseases such as Influenza, HPV, Hepatitis, HIV and Tuberculosis despite rise in sanitation practices globally. In the past, antimicrobials medicines were used to fight powerful infectious disease but slowly in todays time antimicrobial agent is not able to give the desired results because the problem of drug resistant occurs in many people across the world.

Nowadays, a new diagnostic procedure is being followed to fight infectious disease like molecular diagnostic test is very effective which is quite fast and precise. The number of cancer patients is increasing very fast, so it is believed that in the coming time the molecular diagnostic test market will be growing at rapid pace. Global Molecular Diagnostics Market is likely to surpass US$ 22.5 Billion by the end of year 2025.

There are various reasons that will propel the market growth in forecast year; rising incidence rate of infectious disease, increasing incidence rate of cancer of all type, increasing people awareness regarding molecular diagnostic, rapid technological growth, widely acceptance of personalized medicine, rising healthcare infrastructure, increasing healthcare per capita expenditure across the developed and developing nation, accuracy of diagnosis, growing population of cardiovascular and neurological disorder etc. In addition, increasing prevalence of genetic disorder will further boost the market in forecast period of time.

The report titled Molecular Diagnostics Market Share & Forecast, By Application (Infectious Diseases, Blood Screening, Oncology, Genetic Testing, HLA (Tissue Typing), Microbiology, Cardiovascular Diseases, Neurological Diseases, Pharmacogenomics and Others), By Technology (PCR, Transcription-Mediated Amplification (TMA), Hybridiazation (In-situ Hybridiazation & FISH), DNA Sequencing & NGS, Microarray and Others), By End User (Hospitals & Academic Laboratories, Clinics and Commercial Laboratories, Others), By Regions [United States, Europe (Expect Russia), India, China, Japan, Brazil, South Korea, Mexico, Russia and ROW], Companies (Roche, Abbott, Myriad Genetics, Qiagen, BioMrieux and Others) provides a complete analysis of Molecular Diagnostics Market.

Market Insight by Application

The report provides comprehensive analysis of molecular diagnostic test market by application into ten parts: Infectious Diseases, Genetic Testing, Blood Screening, Oncology, HLA (Tissue Typing), Microbiology, Neurological Diseases, Pharmacogenomics, Cardiovascular Diseases, and Others. This report also provides key opportunities market and specific factors are given by each application market.

Market Insight by Technology

Here the market is fragmented into six parts; PCR, Transcription-Mediated Amplification (TMA), Hybridiazation (In-situ Hybridiazation & FISH), DNA Sequencing & NGS, Microarray and Others. Besides, many factors are analyzed that influence the growth, challenges and opportunities of market in technological context.

Market Insight by End User

The report provides complete insight of market by End User segments: Hospitals & Academic Laboratories, Clinics & Commercial Laboratories and Others. According to the publisher, Hospitals & Academic Laboratories will hold the largest market in global molecular diagnostic test market in forecast period of time.

Market Insight by Regions

This report covers the complete regional profile by 10 geographical market; United States, Europe, India, China, Japan, Brazil, South Korea, Mexico, Russia and Rest of World (ROW).

Key Topics Covered:

1. Executive Summary

2. Global Molecular Diagnostic Market

3. Market Share - Global Molecular Diagnostics

3.1 By Application

3.2 By Technology

3.3 By Countries

3.4 By Companies

4. Application - Molecular Diagnostics Market

4.1 Infectious Diseases

4.1.1 Hospital Acquired Infections (HAI)

4.1.2 HIV / HCV Testing

4.1.3 STD Testing

4.1.4 HPV Testing

4.2 Blood Screening

4.3 Oncology / Cancer

4.3.1 Breast

4.3.2 Colorectal

4.3.3 Prostate

4.3.4 Others

4.4 Genetic Testing

4.5 HLA (Tissue Typing)

4.6 Microbiology

4.7 Cardiovascular Diseases

4.8 Neurological Diseases

4.9 Pharmacogenomics

4.10 Others

5. Technology - Molecular Diagnostics Market

5.1 PCR

5.2 Transcription-Mediated Amplification (TMA)

5.3 Hybridiazation (In-situ Hybridiazation & FISH)

5.4 DNA Sequencing & NGS

5.5 Microarray

5.6 Others

6. Region - Molecular Diagnostics Market

6.1 United States

6.2 Europe

6.3 India

6.4 China

6.5 Japan

6.6 Brazil

6.7 South Korea

6.8 Mexico

6.9 Russia

6.10 Rest of World (ROW)

7. End Users - Molecular Diagnostics Market

7.1 Hospitals & Academic Laboratories

7.2 Clinics and Commercial Laboratories

7.3 Others

8. Roche Diagnostics - Company Analysis

8.1 Merger & Acquisitions

8.2 Sales Analysis

9. Abbott Laboratories - Company Analysis

9.1 Merger & Acquisitions

9.2 Sales Analysis

10. Myriad Genetics - Company Analysis

10.1 Merger & Acquisitions

10.2 Sales Analysis

11. Qiagen - Company Analysis

11.1 Merger & Acquisitions

11.2 Sales Analysis

12. BioMrieuxs Inc - Company Analysis

12.1 Merger & Acquisitions

12.2 Sales Analysis

13. Market Drivers

13.1 Various Developments in the Molecular Diagnostics Landscape

13.2 Integral to Traditional Labs

13.3 Improved Assay / Test Efficiencies

13.4 Targeting Antibiotic Resistance

13.5 Next Generation Ultrasensitive Molecular Diagnostics

13.6 Increasing Investment in Genomics & Proteomics Research

13.7 Technological Advances in Molecular Diagnostics

13.8 Increasing Acceptance of the Personalized Medicine

13.9 Growing Molecular Diagnostics for Food Safety

14. Challenges

14.1 Dearth of Trained Professionals

14.2 Regulatory Issues

14.3 Various Factors Slowing Growth of Molecular Diagnostics

14.4 Reimbursement Capabilities

14.5 Quality Checkpoints, Awareness & Acceptance

For more information about this report visit https://www.researchandmarkets.com/r/j3on5s

View source version on businesswire.com:https://www.businesswire.com/news/home/20200130005474/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager

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Global Molecular Diagnostics Market is Likely to Surpass US$ 22.5 Billion by the End of Year 2025 - ResearchAndMarkets.com - Associated Press

As we herald in the new decadeone that will be entirely driven by digital transformation and the agile integration of innovative technology at a rapid paceenterprises across the board are re-evaluating their internal and external operations from the ground up. In the past decade, we have witnessed new technologies come to lifefrom cloud and edge capabilities, blockchain, to 5G connectivity and beyond. Industries are fighting tooth and nail to bring these technologies first-to-market, and oftentimes expand upon the previously-determined boundaries of what purposes these technologies were built to serve.

Were at a vital turning point as we enter 2020, where organizations across all industries must not only continue to integrate innovative technology into their internal and external operationsthey must reimagine their businesses entirely and rebuild their foundational infrastructure to adopt agility and the ability to pivot on a dime, for when the next big technological advancement undoubtedly rises to the surface.

The healthcare industry is no different.

To date, the healthcare industry has been actively digitizing at a rapid pace. In fact, a recent study shows that a whopping 84 percent of U.S. based healthcare organizations utilize digital health records.

The benefits of this investment alone have been far-reaching. Those healthcare organizations that have switched to digital health records deliver better patient care, provide patients with better outcomes on an individual basis, improve the workplace experience for staff members, and even are able to offer cost-efficient healthcare servicesall in comparison to their non-digital counterparts.

Over the next decade, these organizations will not only continue to reap the benefits of their pre-existing digital transformation efforts but will begin to significantly invest in other next-gen technologies and capabilities to continue to bring new, innovative patient care solutions to the reshaping and hyperconnected healthcare ecosystem.

Digital Capabilities will BlossomThere have already been significant advancements in digital capabilities, beyond simply digitizing records. Healthcare leaders have successfully implemented other capabilities, such as remote and self-monitoring medical chatbots, smart pills, implants and more. Such innovation is a direct reflection of the highly-advanced levels of digitalization throughout the industry.

That being said, wider adoption of AI and automation has yet to be fully realized. In fact, only a mere 33 percent of U.S. healthcare organizations have adopted AI technology. Thats not to say that the ambition for adoption isnt there. Back in 2018, over half of healthcare professionals believed that by 2023 there would be widespread AI adoption throughout the industry.

Going into 2020, we expect to see these ambitions become fully realized. AI is becoming increasingly mainstream in all aspects of patient carefrom the overhaul of triage and administrative capabilities to diagnostics and beyond. It can then help doctors understand more about a patient, through the strategic analysis and activation of pre-existing patient data.

Personalized Medicine will ThriveOur experience is that more than two-thirds (75%) of life sciences and healthcare organizations can customize products and services to almost every single interaction. This is an amazing feat for the industry at largeespecially when considering the lack of AI investment to-date.

We will see these capabilities continue to grow in 2020, as personalized medicine becomes increasingly high-tech and data-driven. As AI becomes increasingly ingrained in the process of personalized and precise medicine, the personalized solutions that are developed will become smarter, more specific and more custom-tailored than ever previously imaginable.

Furthermore, in 2020 medical implants will become increasingly agile and be able to perform more functions to minimize patient input for treatment. Bioprinting tech will bring prosthetics and stent technology to new heights as wellas new materials and build processes become fully-realized. The aforementioned bio- and precision-tech will make medical implants significantly less invasive and safer than ever before.

While these personalized capabilities are certainly not new to the industry, a majority of Americans are not familiar with what personalized medicine even is. Additionally, those who are familiar express tend to express concern over the cost of personalized care, and increasingly other elements such as privacy and data concerns. As medical-tech and digital transformation further push personalized care to new heights, there will also be a significant effort to inform the public about what these solutions are, how they are beneficial to patients and how they can remain affordable as well.

The healthcare industry is at a significant turning point. While digitizing records has been a focal point for industry players in the past, investment in next-gen technology will become bolder and more widespread. AI will play an integral role in helping healthcare organizations take a leap of faith toward becoming fully-digital, hyper-connected and mass-personalized. Its an exciting time to work within the healthcare industry, and a hopeful time for patients who will have access to smarter, better and more personalized patient services at lower cost.

Photo: Andreus, Getty Images

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Transforming healthcare practices and patient care in the digital era - MedCity News

1. Siloed Data Is an Opportunity Lost

Data of all types clinical, financial and operational remain siloed for reasons that range from interoperability issues to legacy systems. This becomes further complicated when redundancies are created through mergers (such as multiple electronic health record systems, enterprise resource planning solutions and enterprise imaging systems).

In addition, payers and providers alike continue to struggle with mining unstructured data for clinical and business insights. For example, the Centers for Medicare and Medicaid Services (CMS) calibrates payments to Medicare Advantage plans based on plan population health as determined through diagnosis codes that identify chronic conditions.

Patient conditions, however, are often not included in the codes captured on claims. As such, payers must conduct a tedious exercise each year to retrieve additional data, sometimes from printed medical charts, to fill in the gaps.

The bottom line: Unused data is an opportunity missed in an industry where resources are stretched increasingly thin, especially when it comes to advancing quality of care and establishing new revenue streams.

Precision medicine has been an extraordinarily important quest for the healthcare community. We are now, at long last, making steady and measurable progress in leveraging genomics to improve outcomes.

In cancer care, for example, it is becoming routine to analyze tumors for known gene mutations or expressions to select treatments likely to be most effective. Yet, despite its tangible benefits, the application of precision medicine, specifically in cancer care, still presents significant challenges. This approach can be expensive, invasive and time-intensive as tumors are analyzed through traditional pathology and genomics.

Increasingly, AI-enabled imaging presents a powerful opportunity to accelerate the identification and application of personalized treatments in ways that are often less invasive, faster and potentially more cost-effective. In the past few years, weve started to see several promising applications of AI in imaging to support precision medicine initiatives.

A study published in the Journal of Neuro-Oncology in April 2019 shows strong potential for using machine learning algorithms to reveal multimodal MRI patterns to accurately and rapidly predict the presence of genotypes and mutations in glioma specifically, isocitrate dehydrogenase (IDH) and 1p19q codeletion status which are good predictors of treatment efficacy.

There has also been substantial progress in AI screening for breast cancer, as shown in this recent study published by Nature in January 2020. These are just a few examples, and the potential for others is limitless.

There are a number of factors at play. First, in our daily lives, weve all come to expect unlimited access to information and services whether online or from our mobile phones. These expectations are now carrying over to our healthcare experience.

At last years HIMSS conference, Dr. Donald Rucker, national coordinator for health IT told attendees, Its long overdue for the healthcare industry to be a part of the smartphone economy and enable patients to access their health data through an app of their choice, at no additional cost.

Giving patients access to their data through mobile devices and apps can drive increased levels of patient engagement and better empower their decision-making. In line with expanding expectations for sharing data with patients, CMS has finalized a rule focused on streamlining patient access to health data.

It is also possible that patients expanded access to their health information might help to fuel nascent interest in crowdsourcing of chronic disease data, which could someday present a wealth of information that clinicians and researchers have struggled to access easily.

HIMSS20: Follow us on Twitter as we gear up for the biggest health IT conference of the year in March.

Even as progress accelerates, the industry continues to face challenges as it works to unlock the greatest value from healthcare data. These include hurdles associated with interoperability, security and privacy as technologies advance faster than policy can keep pace.

Healthcare organizations and payers cannot afford to wait for perfection. Instead, they can make solid advances today that will enable them to accelerate at pace with patient expectations, regulations and technology. It all starts with a data foundation that can support the modern data experience that healthcare organizations and consumers crave.

Creating this new type of data experience requires a new type of data hub one that allows organizations to consolidate their systems on a single platform to unify and share data across applications for better insight. Rather than acting as merely a data repository, the data hub must be able to share and deliver data within an organization for modern analytics and AI so patients and clinicians can benefit from the analysis.

As we enter this data decade, the future is bright for healthcare organizations and the patients they serve. By embracing a modern data experience and building a foundation that ensures its success researchers, providers and payers will be well positioned to improve patient outcomes and elevate operational proficiency in the years to come.

Read more:
It's All About the Data in 2020 and Beyond - HealthTech Magazine

A few days ago, I predicted that there would be few if any surprises with Illumina's (NASDAQ:ILMN) fourth-quarter results. This was an easy prediction to make: Illumina CEO Francis deSouza's presentation at the J.P. Morgan Healthcare Conference earlier this month included some sneak peeks at the company's Q4 performance.

Illumina announced its Q4 results after the market closed on Wednesday. I was right that there wouldn't be many surprises. But there was one twist. Here are the three most important things to know about Illumina's Q4 results.

Image source: Getty Images.

Illumina reported Q4 revenue of $953 million, up 10% year over year. This figure was well above the consensus analysts' revenue estimate of $942.9 million. However, Wall Street analysts made their Q4 projections prior to deSouza's presentation at the J.P. Morgan conference.

DeSouza told conference attendees that Illumina expected to report Q4 revenue of around $950 million. The company's actual revenue total came in slightly higher than that level.

Product revenue increased by 10% year over year to $812 million, with solid sales for NovaSeq and NextSeq. Services and other revenue rose by 9.3% year over year to $141 million. As anticipated, headwinds in the direct-to-consumer market weighed on Illumina's overall growth.

DeSouza didn't provide a hint about what Illumina's Q4 earnings would be. The average analysts' estimate projected that the company would generate adjusted earnings per share (EPS) of $1.58. Illumina handily beat that estimate, though, announcing Q4 adjusted EPS of $1.70 -- up nearly 29% year over year.

I wrote earlier this week, "If there's anything unexpected in Illumina's Q4 results, it will probably be related to expenses that impact the bottom line." And that's exactly where the one surprise in the company's quarterly update occurred.

Illumina's total operating costs were basically flat year over year thanks largely to an 8.5% decline in research and development expenses. This, combined with a $15 million reduction in cost of service and other revenue, helped boost the company's bottom line.

Illumina projects full-year 2020 revenue growth of between 9% and 11%. The company expects earnings per diluted share between $6.45 and $6.65 based on generally accepted accounting principles (GAAP), with non-GAAP EPS between $6.80 and $7.00.

The company's guidance didn't contain any surprises. DeSouza said at the J.P. Morgan conference that Illumina expected to deliver revenue growth in the 9% to 11% range for full-year 2020. Wall Street analysts were expecting full-year adjusted EPS to come in between $6.80 and $7.00, with the average analysts' estimate slightly above the midpoint of the range.

Francis deSouza said that Illumina's management believes "that this is the decade that genomics becomes available to cancer and genetic disease patients on a mass scale and integrates into standard of care." That view could very well be right.Genomic sequencing is a critical part of personalized medicine. Increasingly more new drugs are being developed that target specific types of cancer and that rely on sequencing.

Illumina's dominant position in the genomic sequencing market and its decades of leadership make it the player to beat in capitalizing on the growth that should be on the way. However, the company has some vulnerabilities, notably including its lack of expertise in long-read sequencing. The planned acquisition of Pacific Biosciences of Californiawould have addressed this issue, but it's now off the table.

Perhaps the biggest challenge for Illumina is that, as a growth stock, investors expect higher revenue and earnings growth than the company will be able to deliver over the short term. This could put a damper on the stock at least temporarily. But if deSouza's optimistic view of the future proves to be accurate and Illumina can deliver on its potential, the one-time high-flying stock should take off yet again.

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The 3 Most Important Things to Know About Illumina's Q4 Results - Motley Fool

This interview is a translation of a video discussion posted on Medscape France. It has been edited for clarity.

Michel Zeitouni, MD, MSc: Hello. I am Michel Zeitouni, a cardiologist at the Piti-Salptrire Hospital and a researcher with the organization ACTION Cur (Allies in Cardiovascular Trials, Initiatives and Organized Networks). Today I have the pleasure of welcoming Prof Jean-Claude Tardif to Medscape; we are speaking from the American Heart Association (AHA) 2019 meeting in Philadelphia, Pennsylvania.

Prof Tardif is the research director at the Montreal Heart Institute. He presented a study that made a lot of noise at the AHA, the COLCOT study. COLCOT included more than 4000 patients with myocardial infarction (MI) and found a reduction in cardiovascular events in those who received colchicine compared with the placebo group. Prof Tardif, tell us about the results.

Jean-Claude Tardif, MD: Colchicine is a potent anti-inflammatory drug, and there is an accumulation of data suggesting that inflammation is relevant to the progression of atherosclerosis. The COLCOT study included 4745 patients who were recruited within 30 days of their MI. They all received two antiplatelet agents and a statin, and they underwent angioplasty if necessary. Then they were assigned colchicine at a low dose of 0.5 mg/day or placebo. The average follow-up was 23 months, and we found a 23% reduction in the primary efficacy outcome, which was the combination of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring revascularization.

Zeitouni: The inflammation pathway has been in the spotlight ever since the CANTOS study, which used canakinumab, a drug that we have known well for decades and with which we found some benefits for patients with MI. You also looked at tolerability, since it's a question we ask about colchicine; ultimately, it was tolerated rather well.

Tardif: Perhaps it's in part because we used a low dose of 0.5 mg/day, but we saw no difference in the incidence of adverse effects of any cause or severity, and no difference in the occurrence of diarrhea compared with placebo. There was a very slight increase in nausea, with 1.8% in the active group vs 1.0% in the placebo group. There also was a little more pneumonia in the colchicine group (0.9% vs 0.4%).

Zeitouni: You used a rather broad composite endpoint and saw a consistent effect on each component. One thing that struck those who saw your presentation was colchicines effect on stroke. How do you explain the reduction in stroke? Do you anticipate a COLCOT STROKE study?

Tardif: I'm not sure I have all the answers, but we were not the first to see this. There was a meta-analysis of very small, previously published studies that also suggested a benefit for stroke. Now, is this an anti-atherosclerotic effect related to the anti-inflammatory effect of colchicine? Is it an effect that has something to do specifically with the cerebral arteries? Could there be unsuspected effects on central blood pressure? This remains to be seen. It opens up questions that have yet to be answered but deserve to be tested in clinical trials. So, yes, there will be clinical studies on colchicine in stroke.

Zeitouni: Someone mentioned COLCOT-2 in one of the late-breaking trials. Would you tell us about this trial? Colchicine will be used in primary prevention for diabetics.

Tardif: Exactly. Now that COLCOT-1 has been conducted in patients with a recent MI, there is another study called LoDoCo2, in patients with stable coronary disease, that will be presented in 2020. The next frontier will be the high-risk, primary-prevention patients in what we call COLCOT-T2D. This study will involve 10,000 patients with type 2 diabetes who do not have known coronary heart disease. We will assess cardiovascular efficacy, but we will also look at the occurrence of cancer, cognitive disorders, and dementia, because we will be following these patients for 4 years; the COLCOT-1 patients were followed for an average of 23 months.

Zeitouni: So, colchicine may be the new aspirin in these high-risk patients. You saw a reduction in infarct size in the acute phase or the time of remodeling, and a reduction, perhaps, in rhythm disorders. How do you explain the effectiveness?

Tardif: I believe that it is an anti-atherosclerotic effect via the anti-inflammatory effect. I say this because patients were, on average, 13 days post-MI. And when we look at the time at which the events occurthe effect on the stroke, the effect on urgent hospitalizations for anginait seems more related to the anti-atherosclerotic effect than to an effect on ventricular remodeling.

Zeitouni: Another study that was presented at AHA was COLCHICINE-PCI. Those investigators studied patients undergoing angioplasty, to learn whether the administration of colchicine reduced the rate of infarction or periprocedural myocardial damage. The outcomes assessed were biomarkers of myocardial injury. They did not find any difference in these markers, but they did find that inflammation decreased in the colchicine arm as measured by interleukin-6 levels. What are your thoughts on this? Is there a role for colchicine in angioplasty to reduce periprocedural events?

Tardif: The concept was interesting. I think there were, unfortunately, significant methodologic problems in COLCHICINE-PCI. First, the study included only about 400 patients, so the power was extremely limited. Second, the investigators chose to give only one dose of colchicine before angioplasty and not to repeat it afterwards. It was unlikely that we would see any significant longer-term effects. In contrast, COLCOT had not 400 but 4700 patients, and we treated the patients for 23 months. I am struggling to learn from COLCHICINE-PCI. If we want to repeat the experiment, we should do it with longer treatment duration. The finding of a reduction in periprocedural inflammation is the interesting part for me.

Zeitouni: With all of these results from COLCOT, are we a step further in the fight against the residual risk of our coronary patients. Which postinfarction patients would you treat and for how long?

Tardif: First, which patients? If you remember, at the trial presentation people were saying, "Oh, my goodness, are we now going to add another drug on top of the two antiplatelet agents, the statin, and maybe even an ACE inhibitor?" My answer is, really, is this the most intelligent way to practice medicine?

Zeitouni: It should be personalized.

Tardif: Exactly. Instead of saying, "We will give all medicines to everyone," why not try to tailor them by clinical characteristics? We will obviously do subgroup analyses in COLCOT. It is important to understand that not all the data were analyzed because it became available only a few weeks before the conference. We had put a manuscript together for the New England Journal of Medicine and for the AHA presentation. However, we have work to do in the coming months, analyzing the subgroups as well as others, looking at biomarkersis there a particular genetic profile that could show us the patients who would benefit from colchicine?

Personally, I think it's a bad idea to say that we will give six drugs to everyone. In some patients the disease will be mediated by inflammation, whereas in others it will be mediated by diabetes. So I believe it will be necessary to move toward personalized medicine.

Zeitouni: Precisely, with patients who have inflammation and progressive atherothrombotic disease, and occasionally with some young people, who also relapse despite optimal medical treatment. We have a drug now that is well tolerated, accessible, and with strong evidence.

Tardif: I think we could give it to everyone, but with any medications we give, we should make an effort to understand who in particular benefits.

As to your question about duration of treatment, the average follow-up was 23 months, so perhaps we should treat these patients for 2 years. As I noted, COLCOT-T2D will follow patients for 4 years, but for now I would recommend at least 2 years of treatment.

Zeitouni: Prof Tardif, thank you very much for your explanations and for this study, which will improve the prognosis of our patients. We now know more about inflammation and atherothrombosis, thanks to this type of research.

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Could Colchicine Be the New Aspirin? - Medscape

Believe it or not, here we are: already just a month-plus away from the biggest and best health IT show in the world. It's time to formulate a plan of action.

The HIMSS Global Health Conference & Exhibition, which takes place March 9-13 at the Orange County Convention Center in Orlando, Florida.

HIMSS20, as veteran conference-goers know, offers a unique opportunity to spend a week hobnobbing with some 45,000 or so of your closest friends. It plays host to health IT professionals of all stripes: vendors, clinicians, health system executives, policymakers, military health leaders, patient advocates and other healthcare professionals from across the globe.

Its 300-plus education sessions offer not just continuing ed credits but invaluable perspectives and best practices from industry experts tackling the biggest challenges in healthcare. Its slate of well-known keynote speakers bring galvanizing words to spark inspiration. It social and networking opportunities are terrific opportunities to share and learn from innovative new ideas.

As veteran conference-goers also know, careful planning of one's time in Orlando is key to getting the most out of all that activity. With so much going on at once across the sprawling convention center, having a flexible but well-considered to-do list is essential.

Beyond some of the obvious points that are repeated each year wear comfortable shoes, as they will log many miles! here's some other advice and information to get the most from your conference experience.

For those heading to HIMSS20 for the first time, its guide for first time attendees is a must-read.

Among its key tips: Book hotels early! (HIMSS suggests making reservations through OnPeak, its official housing company.) HIMSS also offers an orientation webinar that will take place a week to 10 days before the show.

The HIMSS20 guide also offers other key advice: badge pickup, education certification, onsite information desk and complimentary shuttle service to hotels and the airport.

Full conference registration includes entry to the Monday night opening reception, all keynote and Views from the Top sessions, all general education sessions between March 10 and March 12, as well as access to the exhibition floor for those days.

But an extra fee gains access to a jam-packed day of preconference education and networking on Monday, March 9.

There are stalwarts such as the CHIME-HIMSS CIO Forum, the AMDIS/HIMSS Physicians Executive Symposium and the Nursing Informatics Symposium, of course.

But there are plenty of other daylong sessions to pique the interest of professionals from all corners of the healthcare space: aging technology and AI, big data and blockchain, cloud and consumerism and much, much more.

HIMSS20 gets started in earnest on Tuesday, March 10, with the opening keynote and discussion: Dr. Gianrico Farrugia, president and CEO of Mayo Clinic, George Halvorson, chair and CEO of the Institute for InterGroup Understanding and Dr. Rod Hochman, president & CEO, Providence St. Joseph Health will talk "Digital Health Transformation: The Path Forward."

Throughout the week, other big names scheduled to give keynotes include National Coordinator for Health IT Dr. Donald Rucker, CMS Administrator Seema Verma, former Governors Chris Christie and Terry McAuliffe and baseball great Alex Rodriguez.

When it comes to education sessions, there's no shortage of them. High-level View from the Top presentations will offer industry leaders discussing everything from AI to APIs, value-based care to virtual reality.

And the hundreds of other education session taking place during the week use this handy search function to find the ones most relevant for you cover nearly every topic imaginable: cybersecurity, interoperability, organizational change management, personalized medicine, population health, quality improvement, user experience, venture investment, and much more.

The beating heart of HIMSS20 will be the Exhibition Floor, with more than 1,300 vendors showing the latest in technology innovation, hundreds more targeted education sessions and more pedestrian traffic than some mid-sized cities. Plan your perambulation with this interactive map.

Attendees should also be sure to stop by any or all of the many Specialty Pavilions, such as the Career Expo, Cybersecurity Command Center, Debut Square, Innovation Live, University Row and, of course, the venerable Intelligent Health Pavilion and Interoperability Showcase.

Throughout the week, be sure to keep an eye on social media, too. HIMSS and Healthcare IT News will be offering a stream on new updates via Facebook and Twitter, so follow the hashtag #HIMSS20 for all the latest. Following the feeds of HIMSS' newest class of Digital Influencers is another great way to stay in the loop with all the latest buzz.

The official HIMSS Global Health Conference Mobile App expected to be made available in February is another must-download, with all the info on educational sessions, exhibitor listings, floor maps, news, networking opportunities and more.

And speaking of networking events there's a ton of them on tap for Orlando in March: an array of receptions, meet-ups, community events, HIMSS chapter confabs, the annual awards gala, and many more. See a full listing here.

HIMSS20 takes place March 9-13 at the Orange County Convention Center in Orlando.

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Some helpful tips to survive and thrive at HIMSS20 - Healthcare IT News

MINNEAPOLIS, Jan. 24, 2020 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ:POAI) ("Predictive Oncology" or "the Company"), a knowledge-driven company focused on applying artificial intelligence ("AI") to personalized medicine and drug discovery, today announces it has signed a letter of intent to acquire Quantitative Medicine (QM).

Dr. Carl Schwartz, president and CEO of Predictive Oncology, believes the synergies created by the acquisition, if completed, will help the Company accelerate the commercialization of its AI-driven technology and services, "By coupling QM's CoRE predictive modeling platform with our tumor profiling expertise and data we believe we can revolutionize the way precision therapies are developed, said Dr. Schwartz."

QM is a biomedical analytics and computational biology company, founded by Dr. Robert Murphy and Dr. Joshua Kangas, both of Carnegie Mellon University, that has developed a novel, computational drug discovery platform called CoRE. CoRE is designed to dramatically reduce the time, cost and financial risk of discovering new therapeutic drugs by predicting the main effects of drugs on target molecules that mediate disease.

Predictive Oncology's Helomics division has built an AI knowledgebase of drug response profiles from over 150,000 cancer cases, Using AI to leverage that data the information can now be integrated with CoRE to build robust predictive models of how specific types of tumors will react to cancer drug therapies.

"Our goal is to provide researchers in pharma, biopharma and diagnostic companies' with actionable insights that will not only drive the development of new precision therapies, companion diagnostics, and biomarkers, but will also help them design better targeted trials," concluded Schwartz. "Working together, we have the potential to dramatically improve patient outcomes." The transaction is expected to complete in Q1-2020.

Completion of the transaction, which is expected to be completed in the first two quarters of 2020, is subject to the negotiation of a definitive agreement and other terms and conditions.

About Predictive Oncology Inc.

Predictive Oncology (NASDAQ:POAI) operates through five segments (Domestic, International, Clinical, CRO and DCHIP), which contain four subsidiaries; Helomics, TumorGenesis, Skyline Medical and Skyline Europe. Helomics applies artificial intelligence to its rich data gathered from patient tumors to both personalize cancer therapies for patients and drive the development of new targeted therapies in collaborations with pharmaceutical companies. Helomics' CLIA-certified lab provides clinical testing that assists oncologists in individualizing patient treatment decisions, by providing an evidence-based roadmap for therapy. In addition to its proprietary precision oncology platform, Helomics offers boutique CRO services that leverage its TruTumor, patient-derived tumor models coupled to a wide range of multi-omics assays (genomics, proteomics and biochemical), and an AI-powered proprietary bioinformatics platform (D- CHIP) to provide a tailored solution to its clients' specific needs. Predictive Oncology's TumorGenesis subsidiary is developing a new rapid approach to growing tumors in the laboratory, which essentially "fools" cancer cells into thinking they are still growing inside a patient. Its proprietary Oncology Discovery Technology Platform kits will assist researchers and clinicians to identify which cancer cells bind to specific biomarkers. Once the biomarkers are identified they can be used in TumorGenesis' Oncology Capture Technology Platforms which isolate and help categorize an individual patient's heterogeneous tumor samples to enable the development of patient specific treatment options. Helomics and TumorGenesis are focused on ovarian cancer. Predictive Oncology's Skyline Medical division markets its patented and FDA cleared STREAMWAY System, which automates the collection, measurement and disposal of waste fluid, including blood, irrigation fluid and others, within a medical facility, through both domestic and international divisions. The company has achieved sales in five of the seven continents through both direct sales and distributor partners. For more information, please visit http://www.predictive-oncology.com.

About Quantitative Medicine Inc.

Quantitative Medicine is a biomedical analytics and computational biology company offering a novel drug discovery platform which dramatically reduces the time, cost and financial risk of discovering new therapeutic drugs by predicting: the main effects of drugs on target molecules that mediate disease; the effects of drugs on other molecules or pathways in the body that could mediate adverse effects; as well as the interaction of these with underlying genetic variations. The platform identifies similarities in relationships of drug candidates screened against a diverse matrix of pathogenic, cellular, molecular and/or systems biology targets. By iteratively adding new data from other existing research or additional experiments, the predictive model is improved. More accurate predictions can be made for previously unobserved effects of putative compounds on target molecules. "Because of the complexity of biological systems, cutting-edge machine-learning methods will be critical for future drug discovery and development."www.qtmed.com

Forward-looking Statements

Certain of the matters discussed in the press release contain forward-looking statements that involve material risks to and uncertainties in the Company's business that may cause actual results to differ materially from those anticipated by the statements made herein. Risks and uncertainties relating to a transaction with Quantitative Medicine include no assurance that a transaction will be completed or, if completed, no assurance that the acquisition of Quantitative Medicine would result in anticipated benefits. Further, the acquisition could involve unanticipated costs, distractions to Company management or other risks or adverse effects, and any issuance of equity securities in the transaction would result in dilution to the Company's stockholders, which may be significant. Other risks and uncertainties regarding the Company's securities include (i) risks related to the recent merger with Helomics, including the fact that the combined company will not be able to continue operating without additional financing; possible failure to realize anticipated benefits of the merger; costs associated with the merger may be higher than expected; the merger may result in disruption of the Company's and Helomics' existing businesses, distraction of management and diversion of resources; and the market price of the Company's common stock may decline as a result of the merger; (ii) risks related to our partnerships with other companies, including the need to negotiate the definitive agreements; possible failure to realize anticipated benefits of these partnerships; and costs of providing funding to our partner companies, which may never be repaid or provide anticipated returns; and (iii) other risks and uncertainties relating to the Company that include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; sales cycles that can be longer than expected, resulting in delays in projected sales or failure to make such sales; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance, if our product is not accepted by our potential customers, it is unlikely that we will ever become profitable; adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; Predictive's ability to implement its long range business plan for various applications of its technology; Predictive's ability to enter into agreements with any necessary marketing and/or distribution partners and with any strategic or joint venture partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of Predictive's technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company's reports filed with the SEC, which are available for review at http://www.sec.gov. This is not a solicitation to buy or sell securities and does not purport to be an analysis of Predictive's financial position. See Predictive's most recent Annual Report on Form 10-K, and subsequent reports and other filings at http://www.sec.gov.

Contact:

Bob Myers651-389-4800bmyers@skylinemedical.com

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Predictive Oncology Inc. Signs Letter of Intent to Acquire Quantitative Medicine (qtmed.com) and an AI Engine (CoRE) that Facilitates Accelerated Drug...

LUND, Sweden, January 28, 2020 / B3C newswire / -- SAGA Diagnostics AB, a cancer liquid biopsy and genomic testing company focused on precision oncology and non-invasive ultrasensitive monitoring of cancer patients, today announces it has entered service agreements with the international pharmaceutical company Servier, based in Paris, France.

These deals exemplify the increased demand we are experiencing for our offerings of ultrasensitive cancer analysis services and analysis kits. We are excited to be working with Servier, who continues to choose us for important translational oncology projects. Lao Saal, CEO of SAGA Diagnostics.

The collaboration will be covering a total of three preclinical/clinical studies and is scheduled to run for approximately two years. In the course of these projects, SAGA Diagnostics will be developing assays and performing liquid biopsy tests on patients from multiple Servier clinical studies using the SAGAsafe technology (formerly known as IBSAFE) to identify and quantify circulating tumor DNA (ctDNA).

SAGAsafe technology is a patented improvement of digital PCR that enables approximately 100-fold increased sensitivity compared to competitor methods, and can be used to quantify mutations in tissue samples as well as liquid biopsies such as blood plasma with unprecedented performance to a limit of detection of ~0.001% mutant allele frequency. The analyses will be run in the SAGA Diagnostics central laboratory in Lund, Sweden.

We have been impressed by the service and ultra-sensitivity performance of SAGAsafes analyses and are looking forward to continue working together. Involving the SAGAsafe technology in these studies means that Servier will now be able to monitor effects at an earlier stage ensuring that we do not miss out on any insights. Brian Lockhart, Director of CentEx-Biotechnology, Servier.

SAGAsafe is part of a portfolio of ultrasensitive technologies, which also includes SAGAsign (formerly known as KROMA) for monitoring chromosomal rearrangements, as well as novel technologies in development. SAGA offers both off-the-shelf analysis services and kits as well as custom-tailored solutions to fit customers needs. SAGAs molecular tools are being used in clinical trials and hospitals for detecting actionable mutations, monitoring treatment response, measuring minimal residual disease, and identifying resistance mechanisms to help direct therapy.

About SAGA Diagnostics ABSAGA Diagnostics AB is a personalized cancer genomics and disease monitoring company that offers molecular genetic testing of tissue biopsies and non-invasive liquid biopsies such as blood samples. With SAGAsafe and SAGAsign services and kits, SAGA helps pharmaceutical companies, scientists, and healthcare providers to detect actionable mutations, stratify patient groups, and monitor treatment response more accurately and to an industry-leading lower limit of detection of 0.001%. Analysis of circulating tumor DNA using these proprietary technologies gives SAGA unique ultrasensitivity, and gives patients peace of mind.Follow us on Twitter@SAGAdiagnosticsandLinkedIn.

Contact

ke Nilsson, BD Director This email address is being protected from spambots. You need JavaScript enabled to view it.+46 733 01 72 42

Keywords: Circulating Tumor DNA; Neoplasm, Residual; Limit of Detection; Precision Medicine; Liquid Biopsy; Medical Oncology; Genetic Testing; Pharmaceutical Preparations

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SAGA Diagnostics Extends its Collaboration with Servier to Use Ultrasensitive SAGAsafe Technology in Cancer Clinical Trials - b3c newswire

This collaboration is helping us accelerate our search for precision biomarkers to prognosticate disease course and to guide early and effective personalized treatment decisions in Crohns disease patients.

BASEL, Switzerland (PRWEB) January 30, 2020

Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced the successful completion of a Data Science Services project in support of the Crohns & Colitis Foundations mission to advance precision medicines for Crohns disease and to improve patients quality of life. Researchers and clinicians collaborated with Genedata data scientists to integrate and analyze multi-omic and clinical data collected from large cohorts of patients with Crohns disease, to identify the most informative biomarkers that can be used to assess the risk to develop serious complications requiring surgery within five years after diagnosis. The combination of certain clinical parameters and specific omic biomarkers has the potential to lead to significant improvement in Crohns disease patient care.

The Crohns & Colitis Foundation, the leading non-profit organization focused on research and patient care in inflammatory bowel diseases (IBD) for over 50 years, serves as a hub for Crohns disease research with the largest collection of IBD patient data from institutions around the world. To achieve the goal of accelerating treatments and cures, the Crohns & Colitis Foundation looked for a partner to leverage the multitude of longitudinal clinical and molecular data from different omic technologies from large Crohns disease cohorts. In choosing Genedata as its partner to integrate and analyze their vast collection of clinical and high-dimensional molecular data, the Crohns & Colitis Foundation recognized the firms extensive domain expertise gleaned over more than 20 years, along with the benefits offered by its unique precision medicine software platform for translational and clinical research, Genedata Profiler. The Genedata team of expert bioinformaticians leveraged these resources to deliver actionable results that could be used to develop a diagnostic product.

Crohns disease is a chronic, often debilitating disease, for which there is currently no cure. Despite several treatment options, currently we lack predictive tests to determine the optimal treatment strategy early in the disease process, when the opportunity to improve outcomes is greatest. There is a significant unmet need to advance new diagnostic tools to enable precision medicine approaches and to optimize patient care according to the severity of the disease course, said Andrs Hurtado-Lorenzo, Ph.D., Senior Director of Translational Research at the Crohns & Colitis Foundation. We decided to implement cutting-edge data analysis methods to integrate clinical and genomic data from patients, as a strategy to advance our biomarker research efforts. We are pleased to have found in Genedata a trusted and reliable partner who provided us with expert knowledge in big multi-omic data analysis. This collaboration is helping us accelerate our search for precision biomarkers to prognosticate disease course and to guide early and effective personalized treatment decisions in Crohns disease patients.

Commenting on the successful completion of the recent project, the CEO of Genedata, Othmar Pfannes, Ph.D., said, The volume and complexity of multi-omic data together with clinical data is growingly rapidly and is challenging to analyze. Our Data Science Services together with our Genedata Profiler platform is set up to address this challenge and to enable our partners to make data-informed decisions on a per-project basis without having to build their own data infrastructure or hire data scientists. Dr. Pfannes continued, We are proud that our expertise has been helpful to the Crohns & Colitis Foundation.

About the Crohns & Colitis FoundationThe Crohn's & Colitis Foundation is the leading non-profit organization focused on both research and patient support for inflammatory bowel diseases (IBD). The Foundations mission is to cure Crohn's disease and ulcerative colitis, and to improve the quality of life for the more than 3 million Americans living with IBD. Its work is dramatically accelerating the research process through its database and investment initiatives; the Foundation also provides extensive educational resources for patients and their families, medical professionals, and the public. For more information, visit http://www.crohnscolitisfoundation.org, call +1-888-694-8872, or email info@crohnscolitisfoundation.org.

About GenedataGenedata transforms data into intelligence with innovative software solutions and domain-specific consulting services that automate complex, large-scale experimental processes and enable organizations to maximize the ROI in their R&D, spanning early discovery all the way to the clinic. Founded in 1997, Genedata is headquartered in Switzerland with additional offices in Germany, Japan, Singapore, the UK, and the US. http://www.genedata.comLinkedIn | Twitter | YouTube

ContactMiles Fisher-PollardGenedataPublic RelationsPhone: +41 61 511 85 61pr@genedata.com

DisclaimerThe statements in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties, including risks associated with uncertainties related to contract cancellations, developing risks, competitive factors, uncertainties pertaining to customer orders, demand for products and services, development of markets for the Company's products and services. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to release publicly the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

All product and service names mentioned are the trademarks of their respective companies.

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Genedata and the Crohn's & Colitis Foundation Collaborate to Improve Patient Care in Crohn's Disease - PR Web

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Salt Lake City, UT -- (ReleaseWire) -- 01/29/2020 -- Intermountain Precision Genomics continues to expand cancer testing through advancements to TheraMap, a test for advanced-stage cancer patients. The new TheraMap test expands the ability to examine a tumor's DNA to provide individualized treatment options.

Cancer is caused by changes in DNA that can make a normal cell become cancerous. Utilizing state-of-the-art genomic technology, TheraMap analyzes and interprets what changes, or gene mutations are present in a patient's tumor DNA.

With the ability to detect important mutation types across more than 500 genes relevant to cancer treatment, relevant gene fusion events including NTRK fusions, and important microsatellite instability (MSI) and tumor mutational burden (TMB) biomarkers, TheraMap results can be used to personalize treatment for each patient.

In addition to its significant gene panel, another feature that sets TheraMap aside from other cancer tests is the molecular tumor board, a multi-institutional group of clinical experts and precision medicine leaders who review the solid tumor results and provide oncologists with recommendations for specific therapies and treatments.

"Our unique process analyzes the genetic makeup of a patient's cancer and employs a team of skilled Molecular Tumor Specialists to review each solid tumor test and determine how to most effectively treat that cancer case," said Lincoln Nadauld, MD, PhD, oncologist and chief of Precision Health and Genomics at Intermountain Healthcare. "Our team approach gives oncologists confidence, information, and support they need to prepare a customized, targeted treatment plan for each patient."

When compared to traditional diagnostic tests and treatment, TheraMap's methods provide significantly better results for patients at lower overall healthcare costs something patient Jeffery Layne appreciates.

In January 2018, Layne was diagnosed with stage four kidney cancer that had spread to other parts of his body and was told that he would have six months to two years to live. Layne's oncologist, Derrick Haslem, MD, associate medical director for the Intermountain Healthcare Oncology Clinical Program, recommended that he try TheraMap.

"The TheraMap test helped to determine exactly what gene mutations were causing Mr. Layne's cancer, allowing us to create an individualized plan for him," said Dr. Haslem.

Utilizing TheraMap's results, Dr. Haslem discovered Layne would be a good candidate for immunotherapy treatment, a personalized infusion that boosts the body's own immune system to fight cancer.

Layne showed a quick response to the treatment with masses under his arms shrinking almost immediately. After just two months of immunotherapy, the masses disappeared and tumors on his lungs were significantly smaller.

"They've come so far in being able to diagnose the problems related to cancer, it's just amazing," said Layne. "As a cancer patient, watching all the progress in precision medicine and cancer research is really encouraging."

Two years later, Layne continues to improve while painting and spending time with his grandkids. View more about Jeffrey Layne's story.

"Intermountain Precision Genomics is pleased with the advances in TheraMap that will continue to help our advanced-cancer patients see better results, which are longer lives and overall improved quality of life," said Dr. Nadauld.

Visit intermountainhealthcare.org/abouttheramap for more information about TheraMap testing.

About Intermountain Precision GenomicsIntermountain Precision Genomics is transforming healthcare by targeting treatment to deliver the highest quality care at some of the lowest costs in the nation, all while helping people live the healthiest lives possible. Intermountain Precision Genomics is a service of Intermountain Healthcare, a system widely recognized as a leader in clinical quality improvement and efficient healthcare delivery. For more information about Intermountain Precision Genomics, please visit intermountainhealthcare.org/genomics.

For more information on this press release visit: http://www.releasewire.com/press-releases/intermountain-precision-genomics-announces-advancements-in-personalized-cancer-care-with-expanded-theramap-test-1273295.htm

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Intermountain Precision Genomics Announces Advancements in Personalized Cancer Care with Expanded TheraMap Test - Press Release - Digital Journal

Fifteen additional U.S. airports will begin screening for travelers who may carry the 2019 Novel Coronavirus (2019-nCoV),the U.S. Department of Health and Human Services (HHS) announced today (Jan. 28).

As the total number of confirmed cases in China continues to climb, U.S. health officials aim to prevent an outbreak at home while studying the newfound disease and developing treatments. "At this point, Americans should not worry for their own safety," HHS Secretary Alex Azar said during a news briefing today. For "the individual American, this should not [have] impact on their day-to-day life."

The purpose of expanding screenings from five airports to 20 is to identify ill passengers returning from China, and to educate travelers about symptoms of the coronavirus so that individuals can seek medical attention if they suspect they may be infected, added Dr. Nancy Messonnier, Director of the National Center for Immunization and Respiratory Diseases.

Local and state health officials, directed by the Centers for Disease Control and Prevention (CDC), remain on the lookout for travelers with signs of respiratory illness or fever who either traveled to China recently or could have made contact with an infected person. In addition, close contacts of infected individuals are being monitored for signs of developing illness; this precaution will help the CDC to catch additional cases and understand how the disease progresses through time, Messonnier said.

"The coming days and weeks are likely to bring more confirmed cases," as well as potential reports of human-to-human transmission within the U.S., said CDC Director Dr. Robert Redfield. But as of yet, "there is no spread of this virus in our communities here at home," he said.

Related: 10 Deadly Diseases That Hopped Across Species

Besides preventing a potential outbreak, CDC officials are developing diagnostic, therapeutic and preventative measures to take down the new virus. Chinese health officials have made the genetic sequence of the virus available online, and using that information, the CDC developed a "rapid" diagnostic test. The agency plans to share the test with domestic and international partners after verifying its accuracy.

As far as treating the viral infection goes, currently, "there is no proven therapy for coronavirus infection," said Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases. In China, a select number of patients are being treated with antiviral drugs, including Remdesivir, which was initially developed as an Ebola treatment, and a drug called Kaletra, made of two separate antiviral medications.

"There's no proven efficacy of these" against the new coronavirus, Fauci said. "That is why it's so important that we get isolates of the virus."

By gathering these isolates, or samples, of the virus from infected people, CDC officials hope to design a therapy that will train patients immune cells to detect and destroy the virus, Facui said. Similar treatments, known as monoclonal antibody therapies, were developed for the coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), but were only tested in petri dishes and animal models, he said. These in-development treatments also could potentially treat the new virus, but likely wouldn't target the bug specifically enough to be particularly effective, Fauci said.

The more isolates of the new virus the CDC can procure, the more "robust" and specific its treatment solutions will be, Azar added. The agency hopes to deploy representatives on the ground in China to study isolates from infected people at the epicenter of the outbreak. The Chinese government will allow international experts from the World Health Organization to work on "increasing understanding of the outbreak to guide global response efforts," according to a statement published Jan. 28. The extent of U.S. involvement has not been clarified yet.

Related: Top 10 Mysterious Diseases

In the meantime, CDC officials are already in the midst of developing a candidate vaccine to innoculate individuals against the new virus. Using the data shared by Chinese health officials, the agency identified a "glycoprotein spike" on the virus' surface that enables the bug to enter host cells. The spike shall serve as an "immunogen" for the vaccine, meaning that the medicine will recognize the virus by binding to the structure, Fauci said.

Fauci said that he predicts, "with some cautious optimism," that the CDC could launch aPhase 1 clinical trial of a potential vaccine within the next three months. This initial trial would test the safety of the vaccine; assuming that the results are positive, the agency would then evaluate the state of the outbreak before proceeding to a larger safety and efficacy trial.

"We are proceeding as if we have to deploy a vaccine we are looking at the worst scenario, that this becomes a bigger outbreak," Fauci said.

As compared to their secretive stance during the 2003 SARS epidemic, Chinese health officials have been "cooperative" in meetings with the CDC and other international partners, and forthright with sharing information, Azar noted. Thanks to this transparency, "within one week, the CDC had invented a rapid diagnostic test. Within two weeks, we have a candidate vaccine that we're working on," he said.

That said, the virus continues to spread rapidly in China, and until the U.S. can deploy researchers to the scene, health officials can only work with the data they have at home. Continued transparency is needed to answer important questions about 2019-nCoV, including where the virus came from, whether asymptomatic people can transmit the infection, and how many cases have truly occurred so far, Azar said.

Originally published on Live Science.

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Coronavirus screening expands to 20 US airports; researchers start work on a new vaccine - Livescience.com

Dr. McKibbens first-hand knowledge and experience in pediatric therapies, pediatric trials, preventative medicine, and clinical regulatory strategy, both at the FDA and in the Industry, make her an excellent addition to our team of Expert Consultants.

ROCHELLE, Va. (PRWEB) January 29, 2020

NDA Partners Chairman Carl Peck, MD, announced today that Dr. Linda McKibben, a former Pediatric Medical Officer/Clinical Reviewer in the Division of Vaccines and Related Products at the FDA Center for Biologics Evaluation and Research (CBER), has joined the firm as an Expert Consultant. Dr. McKibbens expertise includes pediatric therapies, pediatric trials, preventative medicine, public health, health policy, and clinical regulatory strategy.

Prior to joining the FDA, Dr. McKibben served in multiple roles at the US Centers for Disease Control and Prevention as Senior Advisor for Health Services Research at the National Center for Infectious Diseases (NCID), Senior Medical Officer in the Office of HealthCare Partnerships (OHP), and Medical Epidemiologist at the National Center for Prevention of Injuries (NCIPC). She has also served as a Senior Policy Analyst/Medical Director of Altarum Institute (Alexandria, Virginia), and Vice President of Health Policy at The Lewin Group (Falls Church, Virginia).

Most recently, she served as a Clinical Trials Medical Consultant for Ripple Effect Communications, where she supported the Deputy Director of Extramural Research at NIHs National Institute for Child Health and Human Development, and as a Medical Consultant in the Integrated Product Development Division of PAREXEL Consulting.

According to Dr. Carl Peck, Dr. McKibbens first-hand knowledge and experience in pediatric therapies, pediatric trials, preventative medicine, and clinical regulatory strategy, both at the FDA and in the Industry, make her an excellent addition to our team of Expert Consultants. We are very pleased to welcome her to NDA Partners.

Dr. McKibben earned her medical degree from the Medical College of Georgia, Doctor of Public Health degree in Health Policy from the University of Michigan, Master of Public Health degree from Harvard University, School of Public Health, and bachelors degree in microbiology/pre-medicine from the University of Georgia. She is a fellow of the American Academy of Pediatrics and board certified in preventative medicine.

About NDA PartnersNDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.

ContactEarle Martin, Chief Executive OfficerOffice: 540-738-2550MartinEarle@ndapartners.com

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Dr. Linda McKibben, Former FDA Pediatric Medical Officer, Division of Vaccines and Related Products, Joins NDA Partners - PR Web

January 28, 2020

By: Nigel Coke, Inter-American Division News, and Adventist Review

We are doing a fabulous job of not moving enough, Jason Aragon said as he started his presentation dubbed, Stand Up, Stand Up.

Aragon was referring to a global survey done on levels of inactivity for 2001 to 2016, which showed that 8 out of 10 adults and children do not engage in enough physical activities on a weekly basis and that this was a leading risk factor for non-communicable diseases, mental health challenges, and lower quality of life.

Highlighting figures from the survey, Aragon pointed out that inactivity was no different in all demographics, regardless of whether people are rich or poor.

Doing enough exercise, instead of sitting down daily, will help the oxygen flow to our bodies and in the brain, which will help to give us clarity of thoughts and make better decisions, said Aragon, who is the director of the graduate program in public health and preventative medicine at Montemorelos University in Mexico.

If you want to be rich in terms of your physical fitness, you are the master of your destiny, Aragon said. No other health behavior is as dependent on will power as is exercise, he added. You can be rich when it comes to physical fitness if you put in the work. You can deposit daily to that account.

The Power of Sedentary Behavior

In the Dallas Bed Rest Study of 1966, five individuals were tested for oxygen output and workload (strength) capability after three weeks of total inactivity on bed rest and then after eight weeks of intense physical training. Forty years later, those same five individuals were tested again. The individuals had maintained some regular physical activity over the 40 years. Researchers found that their oxygen output and workload capability had declined over the 40 years (because of aging) about the same amount as it had declined when the five individuals were put on total bed rest for three weeks in 1966. Muscle loss and lowered lung capacity had happened very quickly whenever they stopped physical activity altogether.

Muscle wasting is more accelerated when we are lying down or sitting for long periods than if we were doing physical activities thats the power of moving, Aragon emphasized after describing the Dallas study.

Aragon was presenting on the second day of a health summit hosted by the Inter-American Division (IAD) in Punta Cana, Dominican Republic, January 22-26, 2020. Attendees included church leaders and health ministry directors from across IAD.

During the presentation, the university professor engaged the attendees in physical exercises to illustrate and reinforce the need for physical activities.

In redefining retirement, Aragon posited that retirement is not about finding a place to sit but about being able to move and enjoy life and do things for yourself, not the sedentary lifestyle that was often the case during working life.

In concluding, he warned the audience that if they want to outwalk death, they would have to walk at a quicker pace than they were currently moving.

The muscles grow weaker as we get older. The stronger our muscles, the better we can combat aging. Move as if your life depends on it, because it does.

The original version of this story was posted on the Inter-American Division news site.

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Health Leaders Are Challenged To 'Get Up, Move, and Live Longer' - Adventist Review