NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorizations to Wren Laboratories for a direct-to-consumer saliva SARS-CoV-2 test and a companion specimen collection kit.
The Wren Laboratories COVID-19 PCR Test DTC is a nonprescription version of a previously authorized test designed to detect the SARS-CoV-2 N gene using primers and probes developed for the US Centers for Disease Control and Prevention's CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel.
It was first authorized for use with nasal swabs, washes/aspirates, and bronchoalveolar lavage and later authorized for use with self-collected saliva specimens.
The direct-to-consumer test uses saliva samples collected at home using the nonprescription Wren Laboratories COVID-19 Saliva Test Collection Kit DTC, which is now also authorized by the FDA.
The test may only be used by Wren-designated labs that are CLIA-certified to perform high-complexity tests.