Meals and Drug Administration final week requested that Innova Medical Group cease gross sales of its COVID antigen speedy qualitative take a look at and warned the general public towards utilizing the take a look at, citing issues about its efficiency.
Innova promotes the lateral move immunochromatographic assay, which is designed to detect SARS-CoV-2 nucleocapsid protein antigens in nasal swab specimens, as having demonstrated 97% sensitivity and 99% specificity for detecting infectious sufferers.
In its announcement, nevertheless, the FDA mentioned that it has vital issues concerning the efficiency of the take a look at and the potential for false-negative or false-positive outcomes.
In a warning letter despatched to Pasadena, California-based Innova on Thursday, the FDA wrote that an inspection of the corporate’s facility confirmed that Innova was distributing the take a look at within the US regardless of by no means having obtained advertising and marketing approval, clearance, or authorization. The company additionally mentioned that sure configurations of the take a look at had been labeled with false or deceptive efficiency knowledge.
The FDA requested that Innova instantly stop the sale and distribution of the take a look at and mentioned that every one take a look at customers, healthcare suppliers, and testing program operators ought to both destroy or return Innova exams they’ve.
In April, Innova issued a voluntary recall of sure plenty of the take a look at that had been distributed for non-investigational use solely.
Innova famous in an announcement this week that the FDA acknowledged quite a lot of corrective actions taken by the corporate. “A number of the corrective actions have been accomplished, whereas some are nonetheless underway,” it mentioned, additional noting that “not one of the inspectional observations concern the efficiency of the take a look at.”
“We’re assured that we’re on the pathway to completely adjust to FDA necessities,” Innova added.
In March, Innova CEO Daniel Elliott mentioned that the FDA had rejected two Emergency Use Authorization submissions for an over-the-counter model of the take a look at and that the corporate was getting ready an EUA submission for point-of-care use.
This story first appeared in our sister publication, 360Dx, which gives in-depth protection of in vitro diagnostics and the medical lab market.