US-based clinical diagnostics company BioFire Diagnostics has filed a 510(k) pre-market notification with the US Food and Drug Administration (FDA), for approval of its blood culture identification (BCID) test.
The application included positive results of FilmArray BCID panel, which was studied in various clinical trials.
Requiring only two to three minutes of hands-on time, the panel simultaneously tests positive blood cultures for 90% of gram-positive bacteria, gram-negative bacteria and yeast microbes that cause bloodstream infections.
The test also detects common antimicrobial resistance genes associated with methicillin-resistant staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE) and the newly emerging carbapenem-resistant enterobacteriaceae (CRE).
In addition, the platform helps hospitals to identify infectious causes of sepsis quickly compared to the conventional methods in use.
Mortality rates, duration of hospital stays and overall costs due to sepsis can be reduced with the timely diagnosis and administration of effective treatments, according to the company.
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 expects commercial release of the panel in summer 2013, pending FDA clearance.