The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Visby Medical’s new Respiratory Health point-of-care test, a rapid polymerase chain reaction (PCR) device, for use in Clinical Laboratory Improvement Amendments (CLIA)-waived settings.
The Visby Medical Respiratory Health Test has been designed for the detection and differentiation of upper respiratory infections caused by Influenza (Flu) A and B as well as SARS-CoV-2.
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It is an ‘instrument-free’ platform that fits in the palm of the user’s hand and provides results in less than 30 minutes in point-of-care settings.
Additionally, the test allows clinicians to accurately diagnose and provide treatment for patients.
Visby stated that the Centers for Disease Control and Prevention (CDC) and the Infectious Disease Society of America recommend clinicians use rapid molecular assays rather than rapid influenza antigen diagnostic tests (RIDTs) to improve detection for outpatients.
Visby Medical chief medical officer Dr Gary Schoolnik said: “Accurate, rapid, point-of-care testing can help physicians prescribe appropriate antiviral medications, minimise viral transmission in waiting rooms and improve patient satisfaction.
“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 new PCR test has been supported in whole or in part with federal funds.
These funds came from the US Administration for Strategic Preparedness and Response, Department of Health and Human Services, and Biomedical Advanced Research and Development Authority (BARDA).
Last March, the company received $25.5m in additional funding from BARDA for the development of the Rapid Flu-COVID PCR Test.
