Visby Medical, Inc. was awarded a Biomedical Advanced Research and Development Authority (BARDA) this week that will allow it to expand efforts surrounding the Visby Personal PCR Test, a COVID-19 test seeking to add the capability to distinguish between influenza cases.
The test is meant to be able to diagnose and differentiate between Influenza A/B cases and SARS-CoV-2 infections using a single nasal swab sample. Further, it’s intended as a simple tool, handheld and fully disposable, for use at both point-of-care or over-the-counter use at home. This would eliminate sample transport, lab analysis, and result reporting needs since it could provide direct results in less than 30 minutes.
Originally developed with support from the National Institute of Biomedical Imaging and Bioengineering’s RADx program, the test recently was granted emergency use authorization from the Food and Drug Administration as a COVID-19 test. Going forward, BARDA’s support will also allow Visby to pursue 510(k) clearance.
The end goal is a product capable of reducing patient exposure in point of care settings, reducing strain on the medical system, and more readily available information during flu season.