Visby Medical receives FDA Emergency Use Authorization for respiratory test in CLIA-waived settings

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The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Visby Medical for use of its instrument-free respiratory health test in CLIA-waived settings, such as urgent care clinics and emergency departments, the firm said on Tuesday.

The Respiratory Health Test is a rapid polymerase chain reaction (PCR) device that detects and differentiates upper respiratory infections caused by influenza A, influenza B, and SARS-CoV-2. The test fits in the palm of the hand and provides results in less than 30 minutes at the point of care.

Citing peer-reviewed publications, Visby Medical noted that the Centers for Disease Control and Prevention (CDC) and the Infectious Disease Society of America recommend that clinicians use rapid molecular assays over rapid influenza antigen diagnostic tests (RIDTs) in outpatient settings to improve detection. However, PCR testing has not been widely adopted in these settings, in part because of the expense required to adopt and maintain PCR instrumentation.

Visby Medical said its instrument-free test helps solve this challenge. "Accurate, rapid, point-of-care testing can help physicians prescribe appropriate antiviral medications, minimize viral transmission in waiting rooms, and improve patient satisfaction," Dr. Gary Schoolnik, chief medical officer at Visby Medical, said in a statement. "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."

The project to develop the test and obtain EUA has been supported in whole or in part with a federal contract valued at up to $53.5 million. The Department of Health and Human Services' Administration for Strategic Preparedness and Response Biomedical Advanced Research and Development Authority (BARDA) awarded the contract.

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