Visby Earns FDA OK, CLIA Waiver for PoC Respiratory Health Test

Visby Medical has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance and a CLIA waiver for its point-of-care respiratory test.

The Visby Medical Respiratory Health Test is a PCR test that detects and differentiates between upper respiratory infections caused by Flu A&B, and SARS-CoV-2. The multiplexed molecular device is touted as the first handled test to receive this designation after being awarded emergency use authorization (EUA) in December 2022.

The test fits in the palm of the hand and generates results in under 30 minutes at the point of care. This means clinicians can accurate diagnose and treat patients even in remote care facilities and other healthcare settings where resources are limited and centralized lab services are less accessible, the company 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,” said Dr. Gary Schoolnik, an infectious disease expert, chief medical officer at Visby Medical, and Professor of Medicine at Stanford University. “Fast diagnosis of patients with respiratory symptoms—enabling selection of the most appropriate treatments—is increasingly important to the medical community.”

The project was supported in whole or in part with funding from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA). Further BARDA-funded studies are ongoing to support development of features that would support an at-home respiratory test to further aid in patient care and management decisions.