Meals and Drug Administration final week requested that Innova Medical Group cease gross sales of its COVID antigen fast qualitative check and warned the general public in opposition to utilizing the check, citing issues about its efficiency.
Innova promotes the lateral circulate 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 stated that it has important issues concerning the efficiency of the check 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 check within the US regardless of by no means having obtained advertising and marketing approval, clearance, or authorization. The company additionally stated that sure configurations of the check had been labeled with false or deceptive efficiency information.
The FDA requested that Innova instantly stop the sale and distribution of the check and stated that each one check customers, healthcare suppliers, and testing program operators ought to both destroy or return Innova checks they’ve.
In April, Innova issued a voluntary recall of sure plenty of the check that had been distributed for non-investigational use solely.
Innova famous in a press release this week that the FDA acknowledged a variety of corrective actions taken by the corporate. “A few of the corrective actions have been accomplished, whereas some are nonetheless underway,” it stated, additional noting that “not one of the inspectional observations concern the efficiency of the check.”
“We’re assured that we’re on the pathway to completely adjust to FDA necessities,” Innova added.
In March, Innova CEO Daniel Elliott stated that the FDA had rejected two Emergency Use Authorization submissions for an over-the-counter model of the check 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 supplies in-depth protection of in vitro diagnostics and the medical lab market.