NEW YORK – Lighthouse Lab Services received Emergency Use Authorization from the US Food and Drug Administration this week for a lab-based molecular saliva test for SARS-CoV-2.
Lighthouse received EUA for its SalivaNow SARS-CoV-2 assay, which is intended for detection in saliva of SARS-CoV-2 nucleic acid in individuals suspected by their healthcare provider of being infected with the virus.
The test is a real-time PCR assay. It can be run in laboratories that meet CLIA requirements for high-complexity testing.