21st January 2020 Content supplied by: bioMérieux (Clinical Diagnostics)
Enhanced BIOFIRE® Blood Culture Identification 2 (BCID2) Panel Submitted for FDA Clearance
bioMérieux have announced that BioFire Diagnostics, its molecular biology affiliate, has submitted to the FDA for 510(k) clearance of the BIOFIRE® Blood Culture Identification 2 (BCID2) Panel. The BIOFIRE® BCID2 Panel includes several additional pathogens, an expanded list of antimicrobial resistance genes, and many revised targets compared to the existing BIOFIRE® BCID Panel.
The existing BIOFIRE® BCID Panel, available since 2013, along with BIOFIRE®’s portfolio of syndromic tests, have changed lab workflow and patient management across multiple disease states. The new generation of the BIOFIRE® BCID Panel includes 26 bacteria, 7 yeasts, and 10 antimicrobial resistance genes. These comprise emerging pathogens, such as Candida auris, as well as new targets to more accurately identify methicillin-resistantStaphylococcus aureus (MRSA) and other resistant organisms. The improved breadth and performance of BCID2 panel aims at reinforcing BIOFIRE®’s leadership in the diagnosis of bloodstream infections.
The BIOFIRE® BCID2 Panel is compatible with the FILMARRAY® 2.0 and FILMARRAY® TORCH systems. bioMérieux plans on pursuing BIOFIRE® BCID2 Panel registration in other parts of the world as well.
About the BIOFIRE® FILMARRAY® PLATFORM:
The BIOFIRE® FILMARRAY® System is an FDA-cleared and CE-marked multiplex PCR system that integrates sample preparation, amplification, and detection into one closed system. A BIOFIRE® FILMARRAY® test requires only two minutes of hands-on time and has a total run time of about 45 to 75 minutes, depending on the panel.
The BIOFIRE® FILMARRAY® range has the largest infectious disease pathogen menu commercially available, composed of:
- BIOFIRE® Respiratory Panel (RP, RP2 and RP2plus), identifying between 20 and 22 respiratory viruses and bacteria performed directly on nasopharyngeal swabs in transport media.
- BIOFIRE® RP EZ, identifying 11 viral and 3 bacterial pathogens associated with respiratory infections. FDA-cleared and CLIA-waived for use in the US only.
- BIOFIRE® Pneumonia (PN) and Pneumonia plus (PNplus) Panel, identifying 33 to 34 targets (18 bacteria, 8 to 9 viruses, 7 resistant genes to antibiotics) in sputum (including endotracheal aspirate) and bronchoalveolar lavage (including mini-BAL). 15 of the bacterial targets are reported with semi-quantitative information about the abundance of organism in a given sample.
- BIOFIRE® Blood Culture Identification (BCID) Panel, identifying 27 of the most common causes of bloodstream infections and associated antimicrobial resistance directly from positive blood culture.
- BIOFIRE® Gastrointestinal (GI) Panel, identifying 22 of the most common viral, bacterial, and parasitic causes of infectious diarrhoea directly from stool in Cary Blair transport media.
- BIOFIRE® Meningitis/Encephalitis (ME) Panel, identifying 14 bacterial, viral, and fungal causes of meningitis and encephalitis directly from cerebrospinal fluid.
As of September 30, 2019, the number of BIOFIRE® FILMARRAY® systems installed globally reached about 9,800.>
Date Published: 21st January 2020
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