June 2023—BioMérieux has launched BioFire Fireworks, an integrated software solution for BioFire systems that is part of the company’s Vision Suite data-management product line. Fireworks provides access to a centralized data-management Web portal, giving users insights and analytics into BioFire system performance, utilization, pathogen surveillance, and workflow management. The software was designed, developed, and implemented following industry standards and regulations and gives customers complete control over their data.
Read More »GI panel submitted for 510(k) clearance, 5/14
May 2014—BioFire Diagnostics submitted the FilmÂArray Gastrointestinal Panel to the FDA for 510(k) clearance.
Read More »Clinical study for GI panel, 9/13
BioFire Diagnostics has begun clinical and analytical studies at several hospital-based laboratories in the U.S. to evaluate the company’s FilmArray gastrointestinal panel. BioFire plans to seek CE IVD marking and FDA clearance for the test.
Read More »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.
Read More »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.
Read More »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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