On Friday, the Meals and Drug Administration issued an emergency use authorization for over-the-counter sale to Lucira Well being’s mixture COVID-flu disposable at-home take a look at.
The Lucira take a look at is the primary such mixture package to be issued over-the-counter emergency authorization by the FDA, and no prescription is required. Customers take nasal swabs, accumulate samples and in half-hour know whether or not or not they’ve the flu or COVID-19.
A Lucira mixture COVID-flu take a look at for point-of-care use in healthcare settings was licensed in November 2022.
The take a look at precisely recognized 99.3% of negatives and 90.1% for positives of the influenza A pressure, 99.9% of negatives for the influenza B pressure and 100% of negatives and 88.3% of constructive samples for COVID-19.
Measuring the efficacy for influenza B-positive samples was unimaginable because of the low circulation of that pressure; there weren’t sufficient instances to conduct a medical examine.
The FDA urges residents to recollect the opportunity of false positives and negatives and to comply with up on the at-home checks with a healthcare supplier.
“In the present day’s authorization of the primary OTC take a look at that may detect Influenza A and B, together with SARS-CoV-2, is a significant milestone in bringing better client entry to diagnostic checks … The FDA strongly helps innovation in take a look at growth, and we’re desperate to proceed advancing better entry to at-home infectious illness testing,” stated FDA Middle for Gadgets and Radiological Well being Director Jeff Shuren.
The FDA authorization might have come too late for Lucira Well being, nonetheless.
The corporate filed for Chapter 11 chapter and introduced it was seeking to promote its enterprise on Wednesday, partly as a result of they might not accumulate over-the-counter income on the checks throughout flu season.
The corporate had initially anticipated the FDA authorization in August 2022. The gradual erosion of COVID restrictions throughout 2022 additionally decreased demand for the at-home checks, that are presently being offered on the Lucira web site for $99.
