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

The US Food and Drug Administration on Friday April 16th 2021 issued separate Emergency Use Authorizations for two molecular SARS-CoV-2 tests developed by Synergy Diagnostic Laboratory.

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.