Emerging Tests

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 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.

Policy A

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.

Policy B

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

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

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.

EUA Updates

As of March 27, the FDA had granted 15 EUAs for COVID-19 tests, including:

(in chronological order of approval date)
  • US Centers for Disease Control and Prevention: 2019-nCoV Real-Time RT-PCR Diagnostic Panel to detect coronavirus
  • New York State Department of Public Health: New York SARS-CoV-2 RT-PCR Diagnostic Panel for emergency use by public laboratories in the state
  • Roche: Cobas SARS-CoV-2 Test for qualitative detection in nasopharyngeal and oropharyngeal swab samples
  • Thermo Fisher Scientific: TaqPath COVID-19 Combo Kit for qualitative detection of SARS-CoV-2 nucleic acid in nasopharyngeal swab, nasopharyngeal aspirate and bronchoalveolar lavage specimens
  • Hologic: Panther Fusion SARS-CoV-2 assay for use on firm’s Panther Fusion, which can provide results in less than three hours and process up to 1,150 coronavirus tests in 24 hours
  • Quidel: Lyra SARS-CoV-2, RT-qPCR assay for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens
  • Abbott: Abbott RealTime SARS-CoV-2 EUA run on firm’s PCR-based m2000 RealTime System
  • Quest Diagnostics: SARS-CoV-2 rRT PCR test
  • GenMark Diagnostics: ePlex SARS-CoV-2 Test for qualitative detection in nasopharyngeal swab samples used on firm’s sample-to-answer ePlex system
  • DiaSorin Molecular: Simplexa COVID-19 Direct assay run on firm’s sample-to-answer Liason MDX real-time PCR instrument
  • Cepheid: Xpert Xpress SARS-CoV-2 (first point-of-care COVID-19 test receiving EUA)
  • Primerdesign: COVID-19 Genesig Real-Time PCR assay
  • Mesa Biotech: Accula SARS-CoV-2 test
  • BioMérieux: BioFire COVID-19 test
  • PerkinElmer: New Coronavirus Nucleic Acid Detection Kit

(See “FDA Watch” for a list of all new tests receiving FDA approval this month)


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