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Visby Medical Nabs FDA EUA for POC Respiratory Panel Test

NEW YORK – Visby Medical's respiratory panel test has received Emergency Use Authorization from the US Food and Drug Administration, according to a letter from the agency.

The RT-PCR assay simultaneously detects and differentiates between SARS-CoV-2, influenza A, and influenza B viral RNA in nasopharyngeal swab specimens from people suspected of respiratory viral infection consistent with COVID-19. The single-use test is authorized for use at the point of care and in laboratories that meet the requirements to perform high-, moderate-, or waived-complexity tests.

In 2021, the company received $12.3 million from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to develop a handheld diagnostic test for SARS-CoV-2 and influenza. Earlier this year, the company announced it would execute a $25.5 million contract option with the Office of the Assistant Secretary for Preparedness and Response in BARDA to develop an at-home version of the test.