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FDA Issues EUAs for SARS-CoV-2 Tests From Synergy Diagnostic Laboratory, Celltrion

NEW YORK — The US Food and Drug Administration on Friday issued separate Emergency Use Authorizations for two molecular SARS-CoV-2 tests developed by Synergy Diagnostic Laboratory and a point-of-care antigen immunoassay for the virus from Celltrion.

The SynergyDx SARS-CoV-2 RNA Test is designed to detect viral nucleic acid in anterior nasal swab specimens collected from symptomatic or asymptomatic individuals by a healthcare provider. It may also be used with anterior nasal swab specimens self-collected using the SynergyDx Home Collection Kit for COVID-19.

Davie, Florida-based Synergy also received EUA from the FDA for a nonprescription version of the test called the SynergyDx SARS-CoV-2 RNA Test DTC, which uses anterior nasal swab samples self-collected at home using the SynergyDx Home Collection Kit for COVID-19 DTC.

Both tests run on Thermo Fisher Scientific's Applied Biosystems 7500 Real-Time PCR System and may only be performed by Synergy-designated labs that are CLIA certified for high-complexity tests, according to the FDA.

The Celltrion DiaTrust COVID-19 Ag Rapid Test is designed for the qualitative detection of nucleocapsid and receptor binding domains from the SARS-CoV-2 virus in nasopharyngeal swab specimens. It uses samples collected from individuals suspected of SARS-CoV-2 infection within the first seven days of symptom onset or from individuals without suspected infection when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

The lateral flow immunoassay provides results within 10 minutes. It may be used by labs CLIA certified to perform high-, moderate-, or waived-complexity tests, as well as at the point of care.

In October, South Korea-based Celltrion received EUA from the FDA for its Sampinute COVID-19 Antigen MIA test.