DC Dispatch: FDA Cracks Down on Antibody Tests

The FDA is pulling COVID-19 antibody tests off the market after enacting a policy in March that allowed diagnostic companies to sell their tests without FDA approval, so long as they are marked as not having been approved. The policy was meant to allow for flexibility while under extreme pressure to ramp up testing availability, but the agency has now found sellers that have made false claims about their test and its accuracy. As of May 4th, sellers have 10 days to submit FDA Emergency Use Authorizations for their active products. So far, of the 180 antibody blood tests sold and distributed in the U.S. without federal review, 28 have withdrawn their tests or neglected to file for review.

Twelve antibody tests have passed the FDA’s emergency authorization process, and the agency is continuing to work with the NIH and CDC to validate more of these serology tests.

These blood tests, like the antibody tests you’ve been hearing about, differ from the COVID nasal swab test because they use a blood sample (most requiring a finger prick) to detect blood proteins called antibodies that are created in response to the virus to counteract it in the body. Experts say COVID-19 antibodies can develop days or weeks after contracting and fighting the virus.

The FDA was aware that their policy would open the door to abusers that would not follow guidelines, and is now thoroughly checking those sellers who have claimed their tests can be used at home (which is not permitted), made unsubstantiated claims about accuracy, or were outright fraudulent.

The 12 FDA approved antibody tests include those made by Vita Testing, Diazyme Laboratories, and Pharmatech.

Doctor Docs: COVID-19 Case Studies for Clinics

Medtrix has developed a machine learning chatbot that gives healthcare professionals quick answers regarding COVID-19 patients, based on information from peer-reviewed literature about patients who tested positive for SARS-CoV2 (viral name for COVID-19). Information about patients treated in accordance to WHO/CDC guidelines is consolidated in this one platform, free for any HCP to use. The Case Player presents actual patient case studies along with data and research on important guidelines for diagnosis and treatment.

The easy-to-use and highly responsive chatbot supports quick decision making based on specific questions from doctors as well as downloadable content for doctors to review. Find the chatbot here: www.medtrixhealthcare.com/chatbot/covidcases.

Patient Pages: Survey Reveals Emotional Pandemic Reaction Across U.S.

The “Flatten the Curve” survey, developed by Sharecare and Dr. Sandro Galea, dean of the Boston University School of Public Health, and Publicis Health Media, shows that 98% of Americans feel they did their part to slow the spread of coronavirus, but a large portion are experiencing anxiety due to pandemic conditions. Results came from 115,000 Americans in April, revealing nine in 10 individuals are impacted by feelings of worry about the novel coronavirus and one in five report severe levels of stress and anxiety.

Financial concerns are dominant, with 65% of respondents across the country indicating worry about their retirement funds and 22% noting they are “very worried” that the country will enter an extended recession. Respondents in Hawaii seem to be the most worried about retirement funds, with 72% of the state indicating their concern, as opposed to 58% in Mississippi, the state with the lowest concern about retirement funds.

Dr. Galea explains, “Our initial analysis of responses to Flatten the Curve confirms many of our fears—in particular, that our stress and mental well-being is being challenged in a myriad of ways—but also bears some glimmers of hope in terms of many people’s chosen health behaviors. In the weeks and months ahead, we must not only continue to do our respective parts to mitigate the spread of the virus, but also urge organizations to seek innovative solutions to proactively support their populations and the communities they serve to make the healthier choice the easier choice throughout this pandemic and beyond.”

Despite the varied financial stressors reported, 23% report pay decreases, 12% indicate job loss, and 27% are somewhat or very likely to have trouble paying their bills, 50% of respondents indicate they are engaging in at least one healthier behavior change since shelter-in-place began. Across the nation, 70% of respondents are exercising more or maintaining their previous routine, 77% indicate they are sleeping the same amount or more, and 78% indicate their drinking has stayed the same or lessened.

Dr. Galea added, “While it may feel like we, as individual Americans, have little control over what happens in our lives right now, it is our personal choices that can be the difference-maker for our communities and our country—especially during this pandemic. While it’s far too early to predict the ‘end’ of COVID-19, one thing that will be critical to our resiliency and recovery throughout this global health crisis is within our own control—making the healthiest, safest choices we can each day for ourselves, and supporting our friends and family in doing the same for themselves.”

Discoveries/Innovations: Breakthrough in Repairing MS Damage

A new therapeutic approach to trns]eating Multiple Sclerosis has been proven able to reverse damage done to the nervous system in mice modeling the disease, and will soon be entering human trials. The research, conducted by a team at the University of Rochester Medical Center (URMC), focuses on glial cells, which play many roles in helping our nervous system function, like forming myelin. Myelin is a fatty substance that surrounds and protects our nerves’ axons, which is the part of our nerves that sends and receives signals from one another. With MS, glial cells called oligodendrocytes are attacked by the individual’s own immune system, essentially breaking down myelin. This leads to an interruption in the signals between nerve cells and results in the motor and sensory function loss seen in MS patients.

This therapeutic method repairs myelin using progenitor glial cells. When the researchers transplanted these progenitor glial cells into mice with MS, they transformed into new oligodendrocytes and restored myelin. Steve Goldman, MD, PhD, of URMC led 15 years’ worth of research to transform stem cells into glial cells. He and his team hoped to use this approach to treat progressive MS, the stage of the disease during which oligodendrocytes have been depleted and can no longer make myelin. They were successful in doing so in their MS model mice, where myelin was restored along with the motor function of the mouse.

Now the university’s startup, Oscine Therapeutics, is preparing the cell therapy for human clinical trials in MS and other glial diseases.

Trend Setting: Health Starts at the Farm

Farm technician transplants new seedlings onto Living Greens Farm’s vertical grow systems. Extra care is taken during this crucial step of growing to ensure plants are kept safe and healthy.

Greens grown aeroponically, or as the revolutionary Living Greens Farm in Minnesota call it, Air-Grown, are now perhaps the safest veggies to buy as well as the healthiest. Living Greens Farm grows its romaine, baby spinach, and other greens in a soilless scaffolding along nine-foot walls in a completely biosecure environment, with limited employees. The roots of these greens are misted automatically with the exact balance of nutrients, pH, and water necessary for them to grow without any outside chemicals, which means they grow with maximum amounts of vitamins and nutrients with the least amount of human contact.

Greens grown in these conditions are not only healthier than outdoor farm-grown veggies, but keep employees safer than labor intensive food producers, namely meat processing facilities. While vertical, indoor farming is gaining notoriety for producing healthier greens with less space and resources, Living Greens Farm is the largest producer, providing produce to multiple states with more facilities to be opened in the coming year. With their Air Grown model, more vitamin-rich, fresher vegetables could become widely available, increasing overall health just from our daily diets. It’s an especially exciting prospect as meat processing factories become havens for COVID-19, leading to possible shortages in the near future.

FDA Update

Drug Approvals

The FDA approves a therapy to treat three types of cancer—non-small cell lung cancer (NSCLC), medullary thyroid cancer, and other types of thyroid cancers. Retevmo (selpercatinib) capsules from Eli Lilly following its acquisition of Loxo Oncology, is the first therapy approved specifically for cancer patients with the RET gene alterations.

Novartis receives accelerated approval of Tabrecta (capmatinib), a kinase inhibitor, for the treatment of adult patients with NSCLC that has spread to other parts of the body. It is the first therapy approved for NSCLC, a disease that causes malignant cancer cells to form in the tissues of the lung, with specific mutations. The FDA also approved FoundationOne CDx assay, by Foundation Medicine, as a diagnostic companion to the drug.

Farxiga (dapagliflozin) oral tablets, from AstraZeneca, are now approved to treat adults with heart failure that show reduced ejection fraction. Farxiga is the first sodium-glucose co-transporter 2 (SGLT2) inhibitor drug to be approved to treat adults with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.

The FDA grants accelerated approval to Incyte’s Pemazyre (pemigatinib) for adults with previously treated unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by FoundationOne CDx.

Med Device Approval

Philips receives FDA approval for their HeartStart FRx Defibrillator, a new, battery-powered, automated, external defibrillator to detect abnormal heartbeat and deliver controlled shocks to those with sudden cardiac arrest.

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