Food and Drug Administration last week requested that Innova Medical Group stop sales of its COVID antigen rapid qualitative test and warned the public against using the test, citing concerns about its performance.
Innova promotes the lateral flow 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 patients.
In its announcement, however, the FDA said that it has significant concerns about the performance of the test and the potential for false-negative or false-positive results.
In a warning letter sent to Pasadena, California-based Innova on Thursday, the FDA wrote that an inspection of the company's facility confirmed that Innova was distributing the test in the US despite never having received marketing approval, clearance, or authorization. The agency also said that certain configurations of the test were labeled with false or misleading performance data.
The FDA requested that Innova immediately cease the sale and distribution of the test and said that all test users, healthcare providers, and testing program operators should either destroy or return Innova tests they have.
In April, Innova issued a voluntary recall of certain lots of the test that had been distributed for non-investigational use only.
Innova noted in a statement this week that the FDA acknowledged a number of corrective actions taken by the company. "Some of the corrective actions have been completed, while some are still underway," it said, further noting that "none of the inspectional observations concern the performance of the test."
"We are confident that we are on the pathway to fully comply with FDA requirements," Innova added.
In March, Innova CEO Daniel Elliott said that the FDA had rejected two Emergency Use Authorization submissions for an over-the-counter version of the test and that the company was preparing an EUA submission for point-of-care use.
This story first appeared in our sister publication, 360Dx, which provides in-depth coverage of in vitro diagnostics and the clinical lab market.