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BioFire Gets 510(k) Clearance, CLIA Waiver for FilmArray Respiratory Panel EZ

NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted 510(k) clearance and CLIA waiver to a respiratory panel from BioMérieux's molecular biology affiliate BioFire Diagnostics, the firm announced today. The test will be available in the US only and is expected to launch in November of 2016.

The FilmArray Respiratory Panel EZ runs in approximately one hour on the FilmArray platform and detects 11 viruses and three bacterial pathogens from nasopharyngeal swabs, requiring two minutes of hands-on time.

Specifically, the test detects adenovirus, coronavirus, human metapneumovirus, human rhinovirus/enterovirus, influenza A, influenza A/H1, influenza A/H1-2009, influenza A/H3, influenza B, parainfluenza, and respiratory syncytial virus, as well as Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

"Syndromic testing is becoming a standard of care for respiratory infections in hospital laboratories [and] further decentralization of the FilmArray across provider networks moves the benefits of syndromic testing nearer to the patient," Randy Rasmussen, CEO of BioFire Diagnostics and vice president of molecular biology at BioMérieux, said in a statement. "The CLIA waiver will make the high medical value associated with FilmArray even more accessible," he added.

BioFire has been conducting clinical research since 2014 to demonstrate its simplified FilmArray system is accurate and easy-to-use in the CLIA-waived setting, according to a poster presented last year at the Chemical and Biological Defense Science and Technology Conference.

The clinical trials were supported by the US Department of Defense Chemical and Biological Defense program through the Defense Threat Reduction Agency (DTRA), with trial sites that included primary care, pediatric, community, and family practice clinics. Tests performed by operators in these settings had 96.8 percent positive agreement and 99.5 percent negative agreement with an FDA-cleared molecular comparative method, the firm said.

At the end of June 2016, the number of FilmArray units installed globally reached about 3,000, the firm noted in a statement. 

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