BioFire Diagnostics has submitted 510(k) pre-market notification application to the US Food and Drug Administration (FDA) seeking approval for its FilmArray blood culture identification (BCID) test.
The application included positive results of BCID panel, which was studied in various clinical trials.
The test, which requires only 2-3 minutes of hands-on time, has the ability to simultaneously detect positive blood cultures for 90% of the gram-positive bacteria, gram-negative bacteria and yeast microbes that cause bloodstream infections.
In addition, the diagnostic test detects common antimicrobial resistance genes associated with methicillin-resistant staphylococcus aureus, vancomycin-resistant enterococci and the newly emerging carbapenem-resistant enterobacteriaceae.
The US-based clinical diagnostics company claimed that mortality rates, duration of hospital stays and overall costs due to sepsis can be reduced with the timely diagnosis and administration of effective treatments.
BioFire Diagnostics CEO Kirk Ririe said the submission of the BCID panel to the FDA marks another milestone in the company's efforts to expand the menu of tests for its FilmArray platform.
"We believe the availability of the BCID Panel, the FDA-cleared Respiratory Panel, and our future Gastrointestinal and Meningitis Panels will continue to increase the utility of the FilmArray in the hospital clinical laboratory," Ririe added.
BioFire anticipates commercial release of the panel in summer 2013, pending FDA clearance.
