FOR IMMEDIATE RELEASE – Nov. 1, 2021
(Charlotte, NC): FDA Grants Emergency Use Authorization for COVID-19 Assay from Lighthouse Lab Services
Lighthouse Lab Services, a national leader in laboratory consulting services, announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its LMSI, LLC d/b/a Lighthouse Lab Services 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 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.
- Real-time RT-PCR test
- For In Vitro Diagnostic Use. For Emergency Use Authorization Only | Rx Only
- Approved for both symptomatic and asymptomatic patients with a provider’s order.
- Received FDA Emergency Use Authorization on Oct. 14, 2021.
Visit Lighthouse Lab Services’ website to learn more about the CovidNow SARS-CoV-2 Assay Kit.
Dustin Suntheimer, Director of Marketing, Lighthouse Lab Services
About Lighthouse Lab Services:
Lighthouse Lab Services is a healthcare consulting and management firm that offers end-to-end technical and business services to clinical, medical, and industrial laboratories across the country. Service offerings include assistance with licensure and compliance with CLIA, COLA, CAP, and other laboratory quality and accreditation requirements, scientific method development and validation for a variety of applications ranging from toxicology to infectious disease, as well as operational solutions. The Company boasts a deep bench of Ph.D. and masters-level analytical chemists, pharmacologists, toxicologists, and laboratory scientists, as well as experienced teams specializing in executive recruiting and staffing and supply chain and logistics management. Lighthouse is headquartered in Charlotte, NC, learn more at www.lighthouselabservices.com.