The Visby Medical platform offers true PCR technology; PCR is the gold standard for testing Flu A, Flu B, and COVID-19. The Visby Medical Respiratory Health Test, which fits in the palm of your hand, provides accurate results in under 30 minutes at the point of care, enabling clinicians to accurately diagnose and treat patients even in remote care facilities and other resource-limited healthcare settings where centralized laboratory services are less accessible.

“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. He added, “Fast diagnosis of patients with respiratory symptoms ­­­­­­­— enabling selection of the most appropriate treatments — is increasingly important to the medical community.”

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50121C00019. Additional BARDA-funded studies are ongoing to support the advanced development of features that would support an at-home respiratory test to further aid in patient care and management decisions.