NEW YORK – Exact Sciences has received a letter from the US Food and Drug Administration granting it Emergency Use Authorization for an in vitro diagnostic assay for the detection of SARS-CoV-2.
The SARS-CoV-2 RT-PCR assay test, which will be performed at Exact's CLIA-certified lab, is a real-time PCR assay intended for the qualitative detection of the virus' nucleic acids in nasal, nasopharyngeal, and oropharyngeal patient swabs.