BioCentury
ARTICLE | Product Development

New U.S. policies complicate regulatory calculus for COVID-19 antibody tests

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April 14, 2020 8:20 PM UTC
Updated on Apr 18, 2020 at 7:18 AM UTC

Guidelines released by CMS, HHS and FDA over the past week raise further questions about the flood of antibody tests that have come on the U.S. market without FDA review. At issue is whether the new policies cancel out the benefits of the speedy path to market for serological tests opened by FDA’s March 16 guidance.

At the time the guidelines were released, only one serological test had received Emergency Use Authorization (EUA) from FDA; 94 others had come on the market without review. That balance may shift if regulatory authorization is required for mandatory insurance coverage and permission to run tests at the point of care. ...