BioFire Diagnostics Inc. announced today the FDA clearance of its updated FilmArray Respiratory Panel. The purpose of the updated panel is to improve the detection of Adenovirus. Studies performed to support the clearance of the modified panel demonstrated a 73% increase in the detection of Adenovirus and a 3-fold improvement in the limit of detection when compared to the original panel.
All existing assays for the 20 viral and bacterial targets in the original Respiratory Panel are unchanged. The updated panel includes an additional assay designed to increase sensitivity and reactivity for the detection of Adenovirus. BioFire plans to make the updated panel available to its customers in April.
FilmArray RP is BioFire's first clinical diagnostic test designed to run on the company's novel FilmArray system, which represents an advancement in user-friendliness and multiplex infectious disease testing capability for hospital clinical labs. FilmArray RP rapidly detects nucleic acids in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. Requiring only two minutes of hands-on time, FilmArray RP has about a 1-hour turnaround time, and simultaneously tests for the following panel of respiratory pathogens: adenovirus, coronavirus 229e, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus, influenza A, influenza A subtype H1, influenza A subtype H3, influenza A subtype H1 2009, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, rhinovirus/enterovirus, respiratory syncytial virus, Bordetella pertussis, Chlamydophila pneumoniae, andMycoplasma pneumoniae. FilmArray RP has received FDA clearance for 20 targets and is available for use by hospital and clinical laboratory professionals in the United States. In addition, the FilmArray RP is CE IVD marked. BioFire is continuing to develop a broader test menu for its FilmArray system, including a blood culture id panel, gastrointestinal panel, and a meningitis panel.