bioMérieux receives emergency-use consent for COVID-19 test production in Salt Lake City
(KUTV) — bioMérieux has received Emergency Use Authorization by the U.S. Food and Drug Administration of its BIOFIRE COVID-19 test for use in CLIA moderate and high complexity clinical laboratories to detect SARS-CoV-2.
bioMérieux, a world leader in the field of in-vitro diagnostics, announced that its subsidiary, BioFire Defense, is currently making every effort to scale up the supply of the BIOFIRE COVID-19 test at multiple production facilities in Salt Lake City, Utah.
Dr. Mark Miller, executive vice president and chief medical officer of bioMérieux, said in a prepared statement:
In the face of this unprecedented global health crisis, bioMérieux is now launching a second diagnostic test for the detection of SARS-CoV2. True to our commitment to public health 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.
The BIOFIRE COVID-19 test detects SARS-CoV-2 in approximately 45 minutes from a nasal swab.
According to a news release, the test runs on the fully automated FILMARRAY 2.0 and FILMARRAY TORCH platforms and is extremely easy to use, therefore requiring minimal training and skills in molecular biology.
BIOFIRE COVID-19 was developed with funding from the U.S. Department of Defense (DoD) by leveraging an existing contract agreement with BioFire Defense. This is the second of three tests being developed for diagnostic use as part of bioMérieux’s strategic response to the COVID-19 pandemic.
“The rapid development of this test is a combined result of the extensive effort and dedication of our employees, the assistance of our partner Midwest Research Institute Global, and the confidence entrusted to us by the U.S. Department of Defense,” said Bob Lollini, CEO of BioFire Defense, in a news release.
The initial test kits are committed to the DoD for redistribution. bioMérieux has also received authorization to sell the BIOFIRE COVID-19 test External Control Kit.
