TMO - FDA streamlines path for emergency use authorization of COVID-19 tests

The FDA today said it has established a streamlined process for companies that want to gain emergency use authorization (EUA) for COVID-19 tests of asymptomatic individuals.The first part is a supplemental template that outlines the data and information that should be submitted to the FDA as part of an EUA request for a molecular or antigen diagnostic test for SARS-CoV-2 used for screening with serial testing.The template is also intended for use by developers of at-home tests.The FDA also said that point-of-care and at-home tests could be authorized for over-the-counter use without the need to validate its use in asymptomatic patients."The FDA believes that evidence of a test's strong performance in symptomatic patients combined with serial testing can mitigate the risk of false results when testing asymptomatic individuals," according to a statement.COVID-19 test manufacturers and developers at close today: Abbott Laboratories (ABT) +0.1; Bio-Rad Laboratories (BIO) -1.6%, Becton, Dickinson (BDX) -0.4%, Thermo Fisher Scientific

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FDA streamlines path for emergency use authorization of COVID-19 tests