Visby Medical announced today that it received FDA emergency use authorization (EUA) for its Respiratory Health point-of-care test.
San Jose, California–based Visby designed its polymerase chain reaction (PCR) test for the fast detection of respiratory infections. Influenza (flu) A and B, as well as SARS-CoV-2 (COVID-19) can cause these upper respiratory infections. The PCR test differentiates between such cases.
The “instrument-free” platform fits in the palm of a user’s hand. Visby said it provides accurate results in under 30 minutes at the point of care. This enables clinicians to accurately and quickly diagnose and treat patients.
Visby said both the CDC and the Infectious Disease Society of America recommends the use of rapid molecular assays. The company said these improve detection for outpatients compared to rapid influenza diagnostic tests.
“Accurate, rapid, point-of-care testing can help physicians prescribe appropriate antiviral medications, minimize viral transmission in waiting rooms, and improve patient satisfaction,” said Dr. Gary Schoolnik, CMO at Visby Medical. “Use of the Visby Respiratory Health Test at the point of care in urgent care clinics and emergency rooms will transform how patients with respiratory symptoms are diagnosed and treated.”
Visby received federal funds to support the development of its PCR test. These funds came from within the U.S. Department of Health and Human Services (HHS). HHS’ Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) provided the contract.