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Visby Medical Wins $12.3M BARDA Contract for Coronavirus, Flu Combo Test

NEW YORK — The US Department of Health and Human Services said on Tuesday that Visby Medical has been awarded a Biomedical Advanced Research and Development Authority contract worth $12.3 million to develop a handheld diagnostic for SARS-CoV-2 and influenza.

According to the HHS, the PCR-based test will be a version of Visby's single-use, fully integrated COVID-19 test, which provides results within 30 minutes and received Emergency Use Authorization in September, multiplexed to include the influenza A and B viruses.

While the SARS-CoV-2 test uses respiratory specimens collected by a healthcare provider or self-collected in a healthcare setting, the new test will be designed for both point-of-care and at-home use as an over-the-counter product, the HHS said.

San Jose, California-based Visby, which was awarded $19 million from the National Institutes of Health last year to develop a single-use gonorrhea test, said that the BARDA contract could be extended to run for a total of 38 months with up to $48.7 million in funding. The company is expected to first seek FDA EUA for the multiplex test, followed by a submission for 510(k) clearance.