A Pasadena startup got billions selling COVID tests. Then came questions

Innova Medical Group moved into a luxury office building in Pasadena. The nursing home participated in a pilot program relying on the Pasadena startup’s antigen test to screen residents’ family members and friends to permit more “meaningful visits.” Less than three months later he was president of Innova, which in September 2020 secured a vast supply of rapid coronavirus tests from an obscure Chinese manufacturer before established pharmaceutical companies could do so. In June, the U.S. Food and Drug Administration said it had “significant concerns” that Innova’s test could produce false results leading to serious illness or death. In Britain, the FDA action in June inflamed an already intense debate in the media and scientific publications over the accuracy of the tests and a decision by the U.K. government to mail millions to homes for mass screenings — even though the manufacturer’s own instructions say they are intended to be administered to patients with symptoms by “trained clinical laboratory personnel.” It’s not the first time that a group of little-known entrepreneurs has made a fortune selling a coronavirus test that is facing questions from regulators. But if you’re using them to say people haven’t got COVID, they’re not good enough to do that.” Dr. Tim Peto, an Oxford University scientist who led the initial government study, said Innova was chosen after its test “passed the threshold of performance” and it became clear the company could supply the test in large quantities.