Inside the FDA’s Four-Armed COVID-19 Test Response Strategy
What started as the traditional Emergency Use Authorization (EUA) response deployed by the FDA for previous infectious illness outbreaks has rapidly evolved into something altogether different and unprecedented featuring four different and parallel pathways. Until now, those pathways were revealed one at a time on a piecemeal basis. But on March 25, the agency assembled […]
What started as the traditional Emergency Use Authorization (EUA) response deployed by the FDA for previous infectious illness outbreaks has rapidly evolved into something altogether different and unprecedented featuring four different and parallel pathways. Until now, those pathways were revealed one at a time on a piecemeal basis. But on March 25, the agency assembled all of the pieces into a single framework while providing new guidance on how each of them works. The clarification came during a webinar provided by CDRH associate director Elizabeth Hillebrenner. Here’s the lowdown.
The pathway the agency calls “Policy A” is for high-complexity CLIA labs seeking to launch validated SARS-CoV-2 laboratory-developed tests, including molecular tests, or antigen or antibody tests. Breaking from previous practice, the FDA is letting labs perform those tests immediately after internal validation without an EUA as long as they notify the agency and apply for an EUA within 15 days. Hillebrenner says the agency had received 98 notifications from labs running LDTs to date.
First unveiled on March 16, “Policy B” allows states to authorize tests to be performed in high-complexity CLIA labs within their jurisdictions. Again, the tests can be run immediately after internal validation and notification to the FDA with no EUA. But unlike Policy A tests, Policy B tests don’t require a subsequent EUA. According to Hillebrenner, four states—New York, Washington, Nevada and Maryland—have notified the FDA of their intent to follow the Policy B pathway.
Policy C is the Policy A counterpart for commercial manufacturers of COVID-19 tests, allowing test makers to launch tests upon validation with an EUA, provided that they notify the FDA immediately and submit an EUA application within 15 business days. Policy C covers molecular, antigen and antibody tests that can be used in clinical labs and at the point-of-care, but not tests intended to be used at home. Hillebrenner says that four manufacturers have notified the FDA that they’re distributing kits under the Policy C path so far: Becton Dickinson, Qiagen, BGI and Co-Diagnostics.
Policy D covers antibody-based serology tests, whether the source is a commercial manufacturer or a high-complexity lab. These tests can be used on patients immediately after validation without the need to apply for an EUA. Over a dozen test developers are pursuing the Policy D pathway.
As of March 27, the FDA had granted 15 EUAs for COVID-19 tests, including:
|COVID-19 TESTS WITH FDA EMERGENCY USE AUTHORIZATION (as of March 27)|
(in chronological order of approval date)
(See “FDA Watch” for a list of all new tests receiving FDA approval this month)
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