bioMérieux receives emergency use authorisation for Biofire COVID-19 test
Monday 30/March/2020 17:52 PM
By: Times News Service
Muscat: Al Hashar Pharmacy’s Aquila Division will play a lead role in providing the automated Filmarray 2.0 and Filmarray Torch equipment to hospitals in Oman for diagnostic testing using the Biofire COVID 19 test kits.
Al Hashar Pharmacy is a leading distributor of pharmaceuticals, healthcare and diagnostics in Oman looking forward to serving the community at large in its fight against the Covid 19 pandemic.
bioMérieux, a world leader in the field of in-vitro diagnostics, announced that its subsidiary, Biofire Defense, has received emergency use authorisation by the US 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.
The Biofire COVID-19 test detects SARS-CoV-2 in approximately 45 minutes from a nasopharyngeal swab in transport media. This 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 US Department of Defense,” said Bob Lollini, CEO of BioFire Defense.
“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,” said Dr Mark Miller, Executive Vice President and Chief Medical Officer of bioMérieux.
bioMérieux has also received authorisation to sell the Biofire COVID-19 test external control kit. This positive control material may be used for quality control and laboratory verification of the test.