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Cepheid, Roche Coronavirus Tests Get FDA Emergency Use Authorization

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for a PCR-based SARS-CoV-2 test developed by Cepheid and a serology test for the virus from Roche.

The FDA also last week reissued an EUA for Quest Diagnostics RC SARS-CoV-2 Assay to permit its use with pooled samples.

Cepheid's Xpert Omni SARS-CoV-2 test is designed to detect the N and E genes of the virus in upper respiratory specimens such as nasopharyngeal swabs, nasal swabs, and nasal wash samples collected by a healthcare provider. Samples are placed in the company's Xpert Omni SARS-CoV-2 cartridge, which run on its automated GeneXpert Omni System.

The test may be used by any lab CLIA-certified to perform moderate- or high-complexity tests, according to the FDA.

In late September, Sunnyvale, California-based Cepheid received FDA EUA for a multiplex SARS-CoV-2, influenza, and respiratory syncytial virus test.

Roche's Elecsys Anti-SARS-CoV-2 S is an electrochemiluminescence immunoassay intended for the qualitative and semiquantitative detection of antibodies to the SARS-CoV-2 spike protein receptor binding domain in serum and plasma. It runs on the Swiss company's line of Cobas E analyzers.

Use of the test is limited to labs CLIA-certified to moderate- or high-complexity tests, the FDA said.

The Quest Diagnostics RC SARS-CoV-2 Assay, which is performed using Roche's authorized Cobas SARS-CoV-2 RT-PCR test, was originally authorized in July for the detection of viral nucleic acid in nasal swab samples self-collected under the observation of a healthcare provider via telemedicine. The next month, the test's EUA was reissued to allow its use with nasal swab specimens self-collected without healthcare provider observation.

Under the latest EUA reissuance, Quest's assay may also be used with pooled samples containing up to six individual upper respiratory swab specimens collected by a healthcare provider or nasal swab specimens self-collected at home.

Use of the assay remains limited to labs designated by Secaucus, New Jersey-based Quest and CLIA-certified to perform high-complexity tests, according to the FDA.

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