NEW YORK – Visby Medical said Wednesday that it has gained US Food and Drug Administration 510(k) marketing clearance and CLIA waiver for a point-of-care respiratory infection assay.
The San Jose, California-based company's Visby Medical Respiratory Health Test is a disposable handheld RT-PCR-based assay that is used for the simultaneous qualitative detection and differentiation of SARS-CoV-2 and flu A/B viral RNA in nasopharyngeal and anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection that is consistent with COVID-19, with results within 30 minutes. The firm received FDA Emergency Use Authorization for the test in December 2022.
The CLIA waiver will enable clinicians to diagnose and treat patients even in remote care facilities and other resource-limited healthcare settings where centralized laboratory services are less accessible, Visby said.
"This FDA decision ensures that accurate, rapid testing with the Visby Medical Respiratory Health Test will remain available to help physicians quickly diagnose and treat patients as they face upcoming respiratory seasons," Visby Chief Medical Officer Gary Schoolnik said in a statement.
The company noted that the development of the test was supported by the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority, which awarded the company a $12.3 million contract in 2021.