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, LLC, its molecular biology affiliate, has received clearances from the U.S. Food and Drug Administration (FDA) to market the FilmArray® Torch for use with the FilmArray® Blood Culture Identification (BCID) Panel, Gastrointestinal (GI) Panel, and Meningitis/Encephalitis (ME) Panel. FilmArray® Torch already received FDA clearance for use with the FilmArray® Respiratory Panel (RP) in February 2016. At the same time, FilmArray® Torch gets CE marked. BioFire will introduce FilmArray® Torch at the ECCMID (European Congress of Clinical Microbiology and Infectious Diseases – Amsterdam April 9-12, booth #85 Hall D) and anticipates commercial availability of FilmArray® Torch this summer in the United States and this fall in Europe.
The FilmArray® Torch provides up to six times more sample throughput per square foot of benchtop space. The high throughput system is a fully integrated, random and continuous access multiplex PCR1 system designed to meet the throughput demands of any size clinical laboratory.
“The FilmArray® Torch delivers the size, scalability, access, and sample throughput that our customers demand. With the CE marking of the system, four FDA-cleared panels and more to come, the high throughput FilmArray® Torch is a major step forward in the global shift toward the syndromic diagnosis of infectious diseases and reinforces our leadership in this market”, said Randy Rasmussen, CEO of BioFire Diagnostics and VP Molecular Biology at bioMérieux.
“Most infections present as a syndrome, with signs and symptoms that are common to a multitude of potential pathogens. Unfortunately, traditional diagnostics force clinicians to make a guess and test for only one or two. FilmArray® eliminates this guessing by rapidly targeting several viruses, bacteria, fungi and/or parasites linked to a clinical syndrome”, added Randy Rasmussen.
FilmArray® is a multiplex PCR system that integrates sample preparation, amplification, and detection into one closed system. The FilmArray® requires only two minutes of hands-on time and has a total run time of about an hour.
The FilmArray® RP is a comprehensive panel of 20 respiratory viruses and bacteria that is performed directly on nasopharyngeal swab-associated viral transport media. The FilmArray® BCID Panel is capable of identifying 27 of the most common causes of bloodstream infections and antimicrobial resistance directly from positive blood culture. The FilmArray® GI Panel identifies 22 of the most common causes of infectious diarrhea directly from stool in transport media. The FilmArray® ME Panel is capable of identifying 14 bacterial, viral, and fungal causes of meningitis and encephalitis directly from cerebrospinal fluid.
At the end of December 2015, the number of FilmArray® systems installed globally increased by more than 1,000 to reach about 2,500 and the FilmArray® revenues grew rapidly year on year.
A world leader in the field of in vitro diagnostics for 50 years, bioMérieux is present in more than 150 countries through 42 subsidiaries and a large network of distributors. In 2015, bioMérieux’s revenues reached €1,965 million with 90% of sales outside of France.
bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
For further information, please visit www.biofiredx.com
BioFire Diagnostics will hold an integrated symposium at the ECCMID :
IS14 - From single to syndromic testing: the new paradigm in microbiology
Sunday April 10 – 4.00 - 6.00 pm – Hall G
1 Polymerase Chain Reaction