Lighthouse Lab Services, a laboratory consulting services company, has announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its CovidNow SARS-CoV-2 Assay Kit, an assay designed to detect COVID-19 using PCR instrumentation.
The EUA covers use for both symptomatic and asymptomatic patients with a provider’s order.
“We are excited to have received Emergency Use Authorization for Lighthouse’s CovidNow SARS-CoV-2 Assay Kit,” says Mark Roth, CEO of Lighthouse. “This product will help expand access to low-cost COVID-19 PCR testing through authorized laboratories serving patients across the country. We are very proud of our talented team whose dedication made this happen. This is a great accomplishment that will advance our mission of making quality laboratory testing more accessible.”
The CovidNow SARS-CoV-2 Assay Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) in human upper respiratory specimens (i.e., nasopharyngeal swab, anterior nasal swab, and mid-turbinate nasal swab specimens) from individuals suspected of having COVID-19 by their healthcare provider.
Testing is limited to laboratories designated by Lighthouse Lab Services and certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a that meet requirements to perform high-complexity tests.
For more information, visit Lighthouse Lab Services.