Salt Lake City-based BioFire Defense, a division of Paris-based bioMérieux, has received emergency use authorization from the U.S. Food and Drug Administration of its COVID-19 test for use in Centers for Medicare and Medicaid Services-approved, moderate- and high-complexity clinical laboratories to detect the virus. Parent company bioMérieux has ordered the ramping up of production capabilities for the test at multiple production facilities in the Salt Lake City area.
The BioFire COVID-19 test detects the virus in approximately 45 minutes from a nasopharyngeal swab. This test runs on the BioFire’s automated Film-array 2.0 and Film-array Torch platforms already in use at nearly 11,000 laboratories worldwide. BioFire said it is extremely easy to use, therefore requiring minimal training and skills in molecular biology.
The test 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 company said.
“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.
The initial test kits produced in Salt Lake City are committed to the DoD for redistribution. Test kits will be available for commercial distribution in the United States under the emergency use authorization as well as internationally where regulatory approval allows. BioMérieux expects to have maximum production capability within a few weeks.