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FDA Grants EUAs for SARS-CoV-2 Tests From Clinical Enterprise, Qorvo Biotechnologies

NEW YORK — The US Food and Drug Administration on Tuesday granted separate Emergency Use Authorizations for molecular SARS-CoV-2 tests developed by Clinical Enterprise and an antigen test for the virus from Qorvo Biotechnologies.

The Clinical Enterprise SARS-CoV-2 RT-PCR Assay is designed to detect the virus's N gene in nasopharyngeal, mid-turbinate, oropharyngeal, and anterior nasal swabs, as well as nasopharyngeal wash, nasal wash, and bronchoalveolar lavage from individuals suspected of infection. The firm, which is a subsidiary of Eurofins, is also authorized for use with nasal swab specimens from asymptomatic individuals.

The test runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio5 384-Well Real-Time PCR System and may be performed only by Clinical Enterprise-designated labs CLIA certified to perform high-complexity tests, the FDA said.

The FDA also authorized a direct-to-consumer version of the Clinical Enterprise assay that uses anterior nasal swab specimens self-collected at home using the Framingham, Massachusetts-based company's EmpowerDX At-Home COVID-19 PCR Test Kit, which received FDA EUA in October.

Qorvo Biotechnologies' Omnia SARS-CoV-2 Antigen Test is designed for the qualitative detection of the nucleocapsid antigens from the virus in direct anterior nasal swab specimens without transport media and collected from individuals suspected of having COVID-19.

The test involves placing a specimen that has been processed using a lysis buffer into a test cartridge, which is then inserted into the Greensboro, North Carolina-based company's Qorvo Omnia instrument.

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