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June 9, 2020

AdvaMedDx Statement On Serology/Antibody Testing

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today released the following statement from Susan Van Meter, executive director of AdvaMedDx, in response to comments on COVID-19 serology/antibody testing at today’s hearing by the Economic & Consumer Policy Subcommittee of the House Committee on Oversight & Reform:

We support the FDA’s pivot in early May to the requirement of Emergency Use Authorization (EUA) for commercial COVID-19 serology/antibody tests, and our companies are committed to the EUA process. So far, more than a dozen commercial serology/antibody in vitro diagnostic tests have received EUAs. Diagnostic test manufacturers are delivering millions of these high-quality, highly sensitive and specific tests each month, and they are all validated to FDA’s exacting standards.

“Serology/antibody tests, along with two other types of COVID-19 tests – molecular diagnostics and antigen – are essential tools for clinicians and public health experts in maximizing diagnostic information to help prevent, detect, and treat COVID-19, in better understanding this new pathogen, and in protecting public health. What’s more, these serology/antibody tests facilitate the critical work of assessing individual and population-based immune response, while also supporting employer workforce testing programs. They also support the screening of potential patients for clinical testing of vaccines, drug therapies in development, convalescent plasma therapy, and measuring the success of vaccination campaigns. Patients and frontline clinicians alike expect and deserve the high-quality, reliable coronavirus tests provided by America’s innovative diagnostics industry, and we will continue to deliver on that promise.”

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

AdvaMedDx member companies produce innovative, safe and effective in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, promote wellness, enable early detection of disease and reduce overall health care costs. Functioning as an association within AdvaMed, AdvaMedDx is dedicated to the issues facing in vitro diagnostic companies both in the United States and abroad. For more information, click here.