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Thermo Fisher Coronavirus Test Gets FDA Emergency Use Authorization

This article has been updated with additional information from Thermo Fisher Scientific.

NEW YORK – The US Food and Drug Administration on March 13 granted Thermo Fisher Scientific Emergency Use Authorization for an assay to detect SARS-CoV-2, the virus that causes coronavirus disease COVID-19. The test can now be used by high-complexity CLIA labs for patient testing.

The test, called the TaqPath COVID-19 Combo Kit, is for the qualitative detection of SARS-CoV-2 nucleic acid in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage specimens from individuals suspected of having COVID-19 by their healthcare provider. It adds to a number of other coronavirus tests that have recently gained EUA.

The test can be run on and is optimized for use on the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument, though it can run on "other authorized instruments," according to the FDA authorization documents. It is designed to provide patient results within four hours of sample receipt by the lab, which includes sample preparation and instrument analysis, Thermo Fisher said.

As of Monday, Thermo Fisher had 1.5 million tests available to ship under the EUA label and expects to increase production to reach 2 million tests per week. Based on available raw materials and the installed instrument base, the firm expects to ramp up production to up to 5 million tests per week in April. Thermo Fisher plans to initially ship those tests to approximately 200 labs in the US and "will continue to work in partnership with government agencies and private partners to expand access," according to a company statement.

The kit contains three primer and probe sets specific to SARS-CoV-2 genomic regions encoding Orf-1ab, N protein, and S protein as well as primers and probes for bacteriophage MS2, and an MS2 phage control reagent. The kit also has an RNA positive control that contains the SARS-CoV-2 genomic regions targeted by the kit.

The test is the second commercial assay to be granted EUA, with a test from Roche receiving authorization earlier on March 13.