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Tag Archives: BioFire Diagnostics—

BioFire POC respiratory panel waived, cleared

Oct. 19, 2016—BioFire Diagnostics has received Food and Drug Administration 510(k) clearance and CLIA waiver for the FilmArray Respiratory Panel EZ. The panel detects 11 viral and three bacterial pathogens associated with respiratory infections from a single patient sample and is a simplified version of the previously FDA-cleared FilmArray Respiratory Panel, which can detect 20 respiratory pathogens. The RP EZ ...

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Higher-throughput FilmArray system cleared

March 8, 2016—The FDA has given 510(k) clearance to BioFire Diagnostics’ new FilmArray platform, which has a smaller footprint and provides six times more sample throughput compared with the existing system. The new system, called FilmArray Torch, has been cleared for use with the FilmArray Respiratory Panel. BioFire, a molecular biology affiliate of BioMerieux, has submitted 510(k) applications for Torch ...

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FDA clears BioFire meningitis/encephalitis panel

Oct. 13, 2015—The FDA has given BioFire Diagnostics a de novo clearance for the FilmArray Meningitis/Encephalitis Panel. This panel is designed to address the need for quick and accurate identification of central nervous system infectious agents by using a comprehensive panel to test cerebrospinal fluid for the 14 most common pathogens responsible for community-acquired meningitis or encephalitis in about an ...

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BioFire submits de novo application for fourth panel

April 30, 2015—BioFire, a bioMerieux molecular biology affiliate, has submitted a de novo classification request to the FDA for the FilmArray meningitis/encephalitis panel. The submission of the panel comes after the completion of a clinical study that included more than 1,500 prospective samples analyzed at 11 different sites across the United States. The panel will be the fourth clinical diagnostic ...

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Blood culture ID test, 6/13:96

BioFire Diagnostics has submitted to the FDA its FilmArray blood culture identification (BCID) panel. The panel received the CE Mark earlier this month. The submission comes after completion of clinical trials for the FilmArray BCID panel, which provides automatic results for common infectious causes of sepsis. BioFire anticipates commercial release of the panel this summer, pending FDA clearance.

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Sample prep patent for multiplex PCR system, 5/13:88

BioFire Diagnostics announced that the U.S. Patent and Trademark Office has issued U.S. patent No. 8,394,608 covering the company’s FilmArray system. This is the first U.S. patent issued to cover the FilmArray system, and BioFire has exclusive rights to the patented technology. The patent specifically covers methods for sample preparation and two-step multiplex polymerase chain reaction in a sealed container.

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Improved adenovirus detection for panel, 4/13:85

BioFire Diagnostics has received FDA clearance for its updated Film-Array 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 percent increase in the detection of adenovirus and a threefold improvement in the limit of detection when compared with the original panel.

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