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CDC to Withdraw EUA for COVID-19 Test; FDA Revokes Three Other EUAs for Non-Use, Agency Clearance

NEW YORK — The US Centers for Disease Control and Prevention said last week it is withdrawing the Emergency Use Authorization for its test for the detection of SARS-CoV-2 while recommending that clinical labs that had been using its test transition to a test that can differentiate the coronavirus from influenza viruses.

Meanwhile, the US Food and Drug Administration has revoked Emergency Use Authorizations for SARS-CoV-2 tests from three other companies.

In a notice, the CDC said it was withdrawing its CDC 2019 Novel Coronavirus Real-Time-PCR Diagnostic Panel after Dec. 31. The test was the first to receive an EUA for detecting SARS-CoV-2. The agency was providing advanced notice of its plans so that clinical labs would have enough time to choose another test.

Additionally, the CDC encouraged the labs to choose a multiplexed test that can be used to detect and differentiate SARS-CoV-2 from influenza viruses. Such tests began hitting the market last fall but had limited use because of a flu season that was almost nonexistent. With much of the global economy reopened and more lax social distancing practices, however, some experts are expecting a busier upcoming flu season, potentially making such multiplexed tests valuable tools.

In the meantime, the FDA revoked EUAs for SARS-CoV-2 tests developed by Gravity Diagnostics, Curative, and BioFire Diagnostics.

The Gravity COVID-19 Assay, which is designed to detect the SARS-CoV-2 N gene, first received FDA EUA in June 2020. The FDA said last week that Gravity had requested that the EUA be revoked since it is no longer using the assay at its clinical lab after transitioning to another test.

In an email, a spokesperson for Gravity said that the company had retired the test methodology in July 2020 and has been using the Gravity Diagnostics SARS-CoV-2 RT-PCR Assay, which provides better coverage of the SARS-CoV-2 viral RNA and internal workflow efficiencies.

In November, Covington, Kentucky-based Gravity received FDA EUA for a test that detects the SARS-CoV-2 N, ORF1ab, and S genes.

The Curative SARS-Cov-2 Assay — formerly the Curative-Korva SARS-Cov-2 Assay — was authorized by the FDA in April 2020. Early this year, however, the agency issued an alert warning patients and healthcare providers about the risk of false negatives with the test.

At the time, San Dimas, California-based Curative — which acquired the test's codeveloper KorvaLabs in mid-2020 — disagreed that the test had performance issues. However, last week the FDA revoked the test's EUA at the request of the company, which said it was transitioning away from using the test at its lab.

The BioFire Respiratory Panel 2.1 received EUA from the FDA in May 2020. About a year later, the Salt Lake City-based company secured de novo clearance for the test, resulting in the FDA revoking the EUA.

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