« Previous article
Spotlight on Antimic...

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.>


    

Tags:

Date Published: 21st January 2020

Source article link: View


View full company details




bioMérieux (Clinical Diagnostics)

Address:

Marcy L'Etoile

France

Tel: +[33] 4 78 87 20 00

Email Supplier

View full company details


Related news from bioMérieux (Clinical Diagnostics)