Penn Avenue Law & Policy Evaluates COVID-19 Tests for Healthcare Client

COVID-19 testing is a rapidly evolving domain. Millions of concerned individuals are seeking COVID-19 tests. Meanwhile, testing healthcare providers continues to be essential, and facility-wide testing is becoming necessary for nursing homes and other senior care communities. When a national healthcare organization needed to evaluate the reliability and limitations of suggested COVID-19 testing, it turned to Penn Avenue Law & Policy for a thorough evaluation and review, as well as strategic direction and advice on effective coronavirus test deployment strategies and processes.

Since February 4, 2020, the U.S. Food and Drug Administration (FDA) has been utilizing its authority under Section 564 of the Federal Food, Drug, and Cosmetic Act to grant Emergency Use Authorizations (EUAs) to in vitro diagnostic products that both detect and diagnose the virus that causes COVID-19. These tests include molecular and antigen diagnostic tests that detect parts of the SARS-CoV-2 virus, and serology/antibody tests that detect antibodies to the SARS-CoV-2 virus, such as IgM or IgG. Diagnostic tests are intended to diagnose current infection with COVID-19. Serology/antibody tests are not intended to detect current infection with COVID-19; rather, serology/antibody tests are intended to detect whether an individual has developed antibodies against COVID-19. Antibodies indicate that the individual was likely infected by COVID-19 in the past. However, there is currently a lack of evidence regarding whether antibodies provide immunity, and if so, the level of immunity, or whether the immunity is short- or long-term.

FDA’s EUA review looks at the “totality of the scientific evidence to make an overall risk-benefit determination” and assesses “the quality and quantity of the available evidence, given the current state of scientific knowledge.” Though FDA’s EUA standards are high, the data and evidence supporting EAU submissions generally include a higher concentration of in vitro data, and smaller sample sizes than are required by the FDA in non-emergency circumstances.

For its national healthcare organization client, Penn Avenue Law & Policy evaluated both diagnostic and antibody tests. Christine P. Bump performed diligence on the manufacturers of select tests, the labeling and claims for the tests, FDA registrations and the regulatory history of the manufacturers, and an in-depth analysis and counsel on the most effective business implementations for each test considered for the client’s network.

Penn Avenue Law & Policy brings deep device and diagnostic expertise to today’s coronavirus challenges for national and multi-national organizations. For more information on how Christine P. Bump could help you effectively navigate the COVID-19 testing and operations maze, contact Penn Avenue Law & Policy at

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