AdvaMed Statement on Biden Administration Plan to Expand K-8 Testing

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AdvaMed Statement on Biden Administration Plan to Expand K-8 Testing

March 17, 2021

WASHINGTON, D.C. – In response to the Biden administration’s announcement today of its plan to expand COVID-19 testing in our nation’s K-8 schools, AdvaMed — the world’s largest trade association representing medical technology companies — released the following statements from AdvaMed President and CEO Scott Whitaker and Susan Van Meter, executive director of AdvaMedDx, the division within AdvaMed that represents diagnostic testing companies:

Whitaker said: “This is a big step forward for our country. We thank President Biden for his leadership here. Our children, perhaps more than anyone else, really, are in desperate need of a ‘return to normal,’ and we support the President’s commitment to achieving this important goal. Our companies are working 24/7 to manufacture the tests needed to prevail over this pandemic, and I know our diagnostics companies will continue their hard work to ensure that we have the tests we need to get back to normal in our society more broadly.”

The announced program recognizes the value of both laboratory-based and point-of-care molecular and antigen tests for the screening of asymptomatic individuals. The announcement follows yesterday’s FDA release of a new COVID-19 Emergency Use Authorization (EUA) template for molecular and antigen test developers seeking claims for screening with serial testing of asymptomatic individuals.

Van Meter said: “Taken together, these new polices, in combination with the substantial supply of quality COVID-19 tests and augmented manufacturing capacity of the diagnostics industry, will improve our collective efforts to recover and rebound from the pandemic, allowing students, teachers and staff to safely conduct in-person school. COVID-19 testing is fundamental to getting us through this pandemic. The diagnostic industry is grateful to assist schools by providing millions of quality COVID-19 molecular and antigen, lab-based and point-of-care tests to support the widespread screening that is so critical to safe, in-person gatherings. We commend President Biden for his leadership and commitment to supporting the K-8 school community.”

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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.