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The startup says its compact, point-of-care test can deliver rapid results, compared with hours or days at centralized labs. Mesa Biotech, a privately held San Diego startup that designs point-of-care flu tests, has received emergency authorization from federal authorities to provide a molecular test for the COVID-19 coronavirus. The company, which employs 50 workers, said its palm-size COVID-19 tests deliver results in as little as 30 minutes. That is significantly faster than the hours or days it can take to get results from centralized labs. The U.S. Food and Drug Administration authorized Mesa’s test for use in moderate to highly complex medical labs, as well as other health settings with trained professionals such as emergency rooms or clinics, said Steven Sepulveda, a vice president of global business development. “What they wanted to do was really broaden where (testing) is done,” said Sepulveda. “Now it is done in central labs. This gets it closer to the patient, in the ER, etc.”
Mesa is the second point-of-care test provider to receive FDA emergency authorization for COVID-19. Cepheid, a Bay Area subsidiary of global life sciences firm Danaher, gained approval for its a 45-minute test last week. Delays in testing have hindered the fight against the coronavirus pandemic in the U.S. Efforts to break the bottleneck include bringing more coronavirus tests from private companies to the fight. Several diagnostic companies with operations in the San Diego region, including GenMark Diagnostics, Quidel Corp., Hologic and Thermo Fisher, recently received emergency approval to provide coronavirus tests to labs. Mesa designed its rapid test with the help of a $561,000 contract from the U.S. Department of Health and Human Services. The company already has approved point-of-care tests for Flu A/B available in the U.S. through a distribution partnership with Sekisui Diagnostics. Mesa said it is ready to ship coronavirus tests immediately under the Accula brand name, though the volume of available tests was not disclosed....
Company's Press Release (March 24, 2020):
https://www.mesabiotech.com/news/euacoronavirus
FDA Approval Letter (March 23, 2020):
