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.
Joshua James Wilson
Nilesh P. Ingle, Ph.D.
Theranos patents at center of lawsuit over startup's COVID-19 tests - Business Insider
March 17, 2020
Documentaries, videos and podcasts
- BiotechnologyBiotechnology can refer to the application of science and technology to living organisms or the use of living organisms, their parts, products or models thereof to solve a problem, produce knowledge or produce goods and services. Biotechnology may involve the alteration of living or non-living materials.
- CompanyA company, abbreviated 'co.', is a legal entity made up of an association of people, be they natural, legal, or a mixture of both, for carrying on a commercial or industrial enterprise.
- Cluster: COVID-19A cluster of topics related to COVID-19. COVID-19 is the abbreviated name for coronavirus disease 2019, a respiratory disease caused by a novel coronavirus strain called SARS-CoV-2. COVID-19 was first detected in Wuhan City, China and the outbreak was declared a pandemic on March 11, 2020 by the WHO.