Business Wire

BioFire Diagnostics Initiates Clinical Study for the FilmArray™ Meningitis/Encephalitis Panel

SALT LAKE CITY--(BUSINESS WIRE)--BioFire Diagnostics, LLC, bioMérieux’s molecular biology affiliate, announced today that it has commenced clinical and analytical studies to evaluate the company’s ...
FierceBiotech

FDA signs off on BioFire Diagnostics' rapid meningitis test

BioMérieux's BioFire Diagnostics got an FDA OK for its rapid meningitis and encephalitis test, a feather in the company's cap as it diversifies its portfolio and ramps up business in an increasingly ...
Business Wire

BioFire Submits 510(k) Application to FDA for FilmArray® Blood Culture Identification Test

SALT LAKE CITY--(BUSINESS WIRE)--BioFire Diagnostics, Inc. today announced that it has submitted the FilmArray Blood Culture Identification (BCID) Panel to the U.S. Food and Drug Administration (FDA) ...
PE Hub

BioFire Diagnostics Ink $25M

BioFire Diagnostics Inc. has raised $25 million in new funding from New York-based Athyrium Opportunities Fund. The money will be used to help commercialize the company’s “FilmArray” diagnostic ...
Pharmabiz

US FDA grants BioFire Diagnostics to market CSF nucleic acid-based test to detect multiple pathogens

The US Food and Drug Administration (FDA) allowed Salt Lake City, Utah-based BioFire Diagnostics to market the first cerebrospinal fluid (CSF) nucleic acid-based test for simultaneous detection of ...
Medindia

BioFire Diagnostics, Inc. Expands Financing Commitment from Athyrium Opportunities Fund to $45 Million

SALT LAKE CITY, May 2, 2013 /PRNewswire/ -- BioFire Diagnostics, Inc. today announced the expansion of its financing commitment with Athyrium Opportunities Fund to $45 million from $25 million. The ...
Finanznachrichten

bioMérieux submits for FDA Clearance of the BIOFIRE FILMARRAY Pneumonia Panel

bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, announces that BioFire Diagnostics, its molecular biology affiliate, has submitted to the Food and Drug Administration for ...
Nasdaq

bioMérieux: BIOFIRE® Respiratory Panel 2.1 (RP2.1) with SARS-CoV-2 Obtains FDA Emergency Use Authorization

MARCY L’ÉTOILE, France--(BUSINESS WIRE)-- Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, its subsidiary ...
FierceBiotech

BioFire Diagnostics wins FDA clearance for innovative GI panel

BioFire Diagnostics won 510(k) clearance for its gastrointestinal panel for infectious diarrhea, following in the footsteps of the company's acquisition by French diagnostic giant bioMérieux.
Finanznachrichten

BIOFIRE Respiratory Panel 2.1 plus with SARS-CoV-2 is CE marked

bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that the BIOFIRE Respiratory Panel 2.1 plus (RP2.1plus) is CE marked. The BIOFIRE Respiratory Panel 2.1 ...
technologynetworks

BioFire Dx Initiates Clinical Study for the FilmArray™ Meningitis/Encephalitis Panel

Infection of the meninges surrounding the brain and spinal cord (meningitis), or of the brain (encephalitis) can have high mortality and morbidity rates depending on the source of infection. Acute ...