AdvaMed Statement on HHS Rescission of Policies on Laboratory Developed Tests During COVID and Beyond

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AdvaMed Statement on HHS Rescission of Policies on Laboratory Developed Tests During COVID and Beyond

August 20, 2020

WASHINGTON, D.C. – AdvaMed President and CEO Scott Whitaker released the following statement:

“AdvaMed fully supports policies that foster innovation and regulatory flexibility to speed quality tests to patients. This principle is core to the industry’s long-standing call for a modernization of the regulatory framework for all diagnostic tests, both commercial in vitro diagnostics (IVDs) developed and manufactured by AdvaMed members, and laboratory developed tests (LDTs).

“During the current public health emergency, the IVD industry has shipped more than 120 million high-quality, molecular COVID tests to laboratories across the country, with capacity to provide 100 million high-quality serology/antibody tests per month, while point-of-care molecular and antigen tests in every state are providing results to patients in minutes, wherever they seek care. And more laboratory and point-of-care tests are coming. Many of our laboratory partners have amplified this with their own tests that have been validated by FDA.

“We encourage the Administration to ensure all diagnostic test developers, of both IVDs and LDTs, are subject to the same standard of test validation during the pandemic and beyond to protect patients and public health. Strategic testing of symptomatic patients and broad screening of asymptomatic individuals are critical to managing the pandemic, and the tests that guide our response should have the confidence of both patients and the public.

“AdvaMed and our partners in the laboratory, health system and patient communities have been working collaboratively to advance legislation that would establish a modernized and right-sized, diagnostics-specific regulatory framework that would embrace innovation so that high-quality diagnostic testing is made rapidly available to patients.

“We will continue to work with the bipartisan cosponsors of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act in both houses, so that all diagnostic tests are subject to the same modernized, risk-based, scientifically rigorous, and efficient regulations in order to ensure quality and patient safety.”

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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.