Quantum Materials Corp. (fka QTMM)

[BigE1960]

About a month old but I don't recall reading that the FDA turned down Innova twice previously:

Diagnostic developers hedge on coronavirus rapid antigen tests, citing conflicting FDA messages

The experience of Pasadena, California-based Innova Medical Group suggests that test vendors were perhaps prudent in not taking FDA's offers of flexibility at face value. The company has produced the kind of cheap (around $5), scalable, but lower performing SARS-CoV-2 rapid antigen tests for which proponents of serial testing have advocated but have not yet been able to get them through FDA.

Daniel Elliott, president and CEO of Innova, said that FDA turned down the company's first two EUA submissions for OTC at-home use of the test. He said it is now preparing an EUA submission for point-of-care use and will then add on submissions for prescription home use and OTC home use.

Elliot said that he believed Innova had run up against the fact that a serial testing model didn't fit well within FDA's traditional approach to evaluating tests in which it is mainly concerned about the performance of a test when used in a single individual at a single time point.

"On the one side, we are advocating to do [serial testing], but on the other side, we have to fit into the very narrow cracks that FDA has defined as how you go through the approval process," he said.

https://www.modernhealthcare.com/safety-quality/diagnostic-developers-hedge-coronavirus-rapid-antigen-tests-citing-conflicting-fda