NEW YORK – Austin, Texas-based testing service provider Discover Labs obtained Emergency Use Authorization from the US Food and Drug Administration last week for a PCR assay to detect SARS-CoV-2.
Called the Discover Labs COVID-19 Assay, the RT-PCR test is for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swab specimens from individuals suspected of COVID-19 infection by their healthcare provider.
Testing is limited to Discover Labs' CLIA facilities, which are authorized to perform high-complexity testing, according to the FDA's letter of authorization.
In addition to the COVID-19 assay, Discover Labs offers a 34-target respiratory pathogen panel, as well as a service that reflexes negative COVID-19 tests to the RPP, according to the lab's website. It also offers a test for urinary tract and sexually transmitted infections that detects 25 pathogens and 20 antibiotic resistance markers, a wound infection test that detects 22 pathogens and 20 antibiotic resistance markers, and a 32-target women's health assay.