A week after the FDA urged anyone who had Innova Medical Group’s COVID-19 antigen test to stop using it and toss it in the trash, regulators across the pond have cleared the rapid diagnostic's use and extended its authorization.
The U.K. Medicines and Healthcare products Regulatory Agency said it found no problems in its own assessment of the test, which it carried out after the FDA delivered a warning letter to the company for pre-emptively delivering unreviewed products to a number of customers and making accuracy claims that did not match up with clinical data.
The lateral flow diagnostic is a cornerstone of the U.K. government’s Test and Trace program—with more than a billion units delivered to the country from factories in China, under contracts worth more than £3 billion, according to a previous report from the Financial Times.
The country aims to screen people nationwide multiple times per week, regardless of whether or not they are showing symptoms, in an effort to catch and quell any new outbreaks. Meanwhile, Innova aims to establish a new manufacturing site in Wales to produce over a million tests per day.
“We have now concluded our review of the risk assessment and are satisfied that no further action is necessary or advisable at this time,” said Graeme Tunbridge, director of devices for the MHRA, which extended its authorization of the test through the end of August.
The FDA’s blunt warning to the public, however, to stop using the tests followed a Class I recall, the agency’s most serious category, voluntarily launched by Innova in late April.
The company had applied for a regulatory green light, but before its review was completed, FDA investigators found that the test had already been distributed to users in a number of states, through inspections of Innova’s California facilities.
And while the FDA did not say it was worried about the performance of the test itself, the agency also found that the labeling of the diagnostic, which comes in different versions, included claims that did not align with results seen in clinical studies—including an analysis conducted last November by researchers at the University of Oxford in the run-up to the U.K. Test and Trace efforts.
Innova previously said it has completed some corrective actions following the FDA’s letter, while others are still underway, and plans to continue its pursuit of a U.S. authorization.
Innova’s kit includes a nasal swab and a test strip, which produces colored lines to display a positive reading in less than a half-hour, similar to a pregnancy test. Oxford’s analysis found the rapid diagnostic had an overall low failure rate as well as a low rate of showing false positives but noted that its accuracy could vary depending on who performed the test—ranging from trained lab professionals to healthcare workers and down to the lay public.