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bioMérieux Receives Emergency Use Authorization for BIOFIRE COVID-19 Test

By LabMedica International staff writers
Posted on 26 Mar 2020
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Image: Illustration of a 2019- novel coronavirus (nCoV) virion (Photo courtesy of CDC)
Image: Illustration of a 2019- novel coronavirus (nCoV) virion (Photo courtesy of CDC)
bioMérieux’s (Marcy-l'Étoile, France) subsidiary, BioFire Defense, has received Emergency Use Authorization (EUA) 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.

bioMérieux provides diagnostic solutions (systems, reagents, software and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. The company’s products are mainly used for diagnosing infectious diseases. The BIOFIRE COVID-19 test detects SARS-CoV-2 in approximately 45 minutes from a nasopharyngeal swab in transport media. 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 US 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. bioMérieux has already launched the SARS-COV-2 R-GENE real-time PCR test running on open platforms. It is produced and available in France and is expected to be rapidly CE-marked and submitted to the FDA for EUA as well. bioMérieux is also developing an expanded version of its BIOFIRE FILMARRAY Respiratory Panel 2, which will be called the BIOFIRE Respiratory Panel 2.1 (RP2.1). This new panel will include SARS-CoV-2 in addition to the 21 other common respiratory pathogens and will deliver results in approximately 45 minutes. It will also be available on the FILMARRAY 2.0 and FILMARRAY TORCH platforms. bioMérieux has also received authorization to sell the BIOFIRE COVID-19 test External Control Kit. The positive control material can be used for quality control and laboratory verification of the test.

“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 DoD,” 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.

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