The French laboratory bioMérieux announced on Tuesday that it has obtained Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration to market a new Covid-19 rapid detection test.
The test, Biofire Covid-19, detects the Coronavirus in about 45 minutes from a nasopharyngeal swab in transport media, the group said in a press release.
It is very simple to use, it added.
The test was developed with funding from the U.S. Defence Department, which will receive the first test kits. Kits will then be available on the U.S. market, under EUA, as well as internationally, “where regulatory approval allows” it, according to bioMérieux.
The French group said it was increasing its production capacity in the Salt Lake City, Utah (USA) area and “expects to have maximum production capability within a few weeks.”
This is the second Covid-19 test developed by bioMérieux. A “real-time” test, SARS Cov-2 R-Gene, was validated in France by the Centre national de référence pour les virus des infections respiratoires (the national virus referencing centre for respiratory diseases) which, bioMérieux said, had welcomed its “excellent results”.
This test, produced in France, should soon be licensed for commercialisation in the European Union.