Biofire Diagnostics

Biofire Diagnostics, LLC is a biotechnology company that provides syndromic infectious disease diagnostic services. The Salt Lake City-based company was founded in 1990. In 2013, the company was acquired by France-based biotechnology and health diagnostics company BioMérieux, becoming BioMérieux’s Global Center of Excellence for Molecular Diagnostics.

Biofire produced the BioFire FilmArray System for comprehensive multiplex PCR testing. The FDA-cleared BioFire System panels test for viruses, bacteria, parasites, yeast, and antimicrobial resistance genes. The company has used its extensive patent portfolio to successfully market nearly 200 products to the clinical, research and military markets. For many pathogens, Biofire has both FDA-cleared and CE-IVD marked assays.

In collaboration with the Department of Defense, BioFire Defense has developed a fully-automated, sample-to-result assay for the specific detection of SARS-CoV-2, the causative agent of COVID-19. The test has been authorized by the FDA under Emergency Use Authorization (EUA). This assay is designed to run on both the BioFire FilmArray 2.0 and BioFire FilmArray Torch Systems, delivering results in about 45 minutes. After meeting initial DoD demand, commercial availability under EUA is anticipated in April of 2020.

In parallel, BioFire Diagnostics is developing new SARS-CoV-2-specific assays for addition to the BioFire FilmArray Respiratory 2 (RP2) Panel. This new panel is named the BioFire Respiratory 2.1 (RP2.1) Panel and is being developed for both the BioFire 2.0 and BioFire Torch Systems. In addition to the detection of SARS-CoV-2, the BioFire RP2.1 Panel will detect 21 additional respiratory pathogens to help clinicians quickly rule in and rule out other common causes of respiratory illness in about 45 minutes. Development of the BioFire RP2.1 Panel is occurring on an accelerated timeline, and submission to the FDA for EUA and 510(k) clearance is anticipated in Q3 of 2020.