Tuesday September 21, 2021

French lab gets US approval for Covid-19 test

March 25, 2020

LYON: French diagnostics firm Biomerieux said Tuesday it had secured emergency approval from US regulators for a coronavirus test that can produce results in 45 minutes, potentially offering a new tool for stemming the outbreak.

The company said its Biofire Covid-19 test was developed with funding from the US Defense Department, which will be distributing the tests while Biomerieux awaits full commercial approval for the US market and elsewhere.

Biomerieux said it is ramping up production at its sites in Salt Lake City, Utah, so that its kits — which rely on easy-to-use nasal swabs — could be widely available in the coming weeks.

Health experts have urged early and widespread testing to find and isolate individuals who are carrying the highly contagious virus as the best way of curbing an outbreak that has already killed nearly 17,000 people since it was first reported in China in December.

But many testing labs have been overwhelmed and require hours if not days to produce results, a bottleneck that can prove deadly as the number of cases increases exponentially once a country reports its first cases.Biomerieux said its coronavirus test is the first of three under development for the virus, whose technical name is SARS-CoV-2.

They include a real-time DNA test for coronavirus that has already been approved by French regulators, which could soon be approved by European and US regulators as well.

“We are making every effort to provide a comprehensive diagnostic approach that meets the highest performance and quality standards to help physicians mount an effective response to the ongoing COVID-19 pandemic,” Mark Miller, chief medical officer at Biomerieux, based in the southeastern French city of Lyon, said in a statement.

On Friday, the FDA said it had issued its first emergency approval for a rapid Covid-19 test to the California-based firm Cepheid, which also said it could produce results within an hour.