BioCentury
ARTICLE | Product Development

As FDA tightens reins on COVID-19 antibody testing, Roche unveils test specs via EUA

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May 5, 2020 2:06 AM UTC
Updated on May 8, 2020 at 9:44 PM UTC

FDA’s reversal of its hands-off policy on antibody tests for the novel coronavirus, coupled with its authorization of a highly anticipated test from Roche, is raising the bar for COVID-19 serology. Yet accessing enough patient samples to minimize uncertainty in test sensitivity remains a challenge, even for the Swiss diagnostic company.

The agency’s updated guidance on COVID-19 tests, published Monday, forces commercial manufacturers to seek Emergency Use Authorization (EUA) for tests detecting patient antibodies against SARS-CoV-2. ...