08:00 , Nov 9, 2015 |  BC Week In Review  |  Clinical News

FilmArray Meningitis/Encephalitis Panel regulatory update

FDA granted 510(k) clearance to bioMerieux’s FilmArray Meningitis/Encephalitis Panel for simultaneous detection of multiple pathogens that can cause CNS infections. The panel is an in vitro multiplex PCR platform that detects 14 bacterial, viral and...
07:00 , Apr 23, 2015 |  BC Innovations  |  Translation in Brief

Funding faster diagnostics

Just two weeks after the White House released its National Action Plan for Combating Antibiotic Resistant Bacteria on March 27, NIH's National Institute of Allergy and Infectious Diseases (NIAID) announced it is awarding more than...
08:00 , Nov 3, 2014 |  BC Week In Review  |  Clinical News

FilmArray BioThreat-E Test regulatory update

FDA granted emergency use authorization (EUA) for the FilmArray BioThreat-E Test from bioMerieux's BioFire Defense LLC subsidiary to diagnose Ebola Zaire virus in patients with signs and symptoms of the disease from whole blood and...
07:00 , Aug 18, 2014 |  BC Week In Review  |  Clinical News

FilmArray Meningitis/Encephalitis Panel: Clinical trial started

bioMerieux’s BioFire Diagnostics LLC subsidiary began a U.S. clinical trial to evaluate the FilmArray Meningitis/Encephalitis Panel. BioFire expects to submit a 510(k) application in the U.S. next year and will seek CE Mark approval of...
08:00 , Feb 24, 2014 |  BC Week In Review  |  Clinical News

FilmArray Gastrointestinal Panel regulatory update

bioMerieux's BioFire Diagnostics LLC subsidiary submitted a 510(k) application to FDA for its FilmArray Gastrointestinal Panel, an in vitro multiplex PCR platform that detects 23 common gastrointestinal bacteria, viruses and protozoa that cause infectious diarrhea....
08:00 , Jan 27, 2014 |  BC Week In Review  |  Company News

BioFire, bioMerieux deal

Diagnostics company bioMerieux completed its acquisition of BioFire for $450 million in cash. bioMerieux also assumed about $35 million of BioFire's net debt (see BioCentury, Sept. 9, 2013). BioFire Diagnostics Inc. , Salt Lake City,...
07:00 , Sep 9, 2013 |  BC Week In Review  |  Company News

BioFire, bioMerieux deal

Diagnostics company bioMerieux will acquire BioFire for $450 million in cash. bioMerieux also will assume an undisclosed amount of BioFire's net debt. BioFire develops and markets in vitro tests for its multiplex PCR FilmArray system....
07:00 , Sep 9, 2013 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory milestones ALK-Abello A/S (CSE:ALK-B) gained DKK8.50 to DKK482 last week after reporting that FDA's Allergenic Products Advisory Committee will meet on Nov. 6 to discuss a BLA from partner Merck & Co. Inc. (NYSE:MRK)...
00:05 , Sep 5, 2013 |  BC Extra  |  Company News

bioMerieux to acquire BioFire

Diagnostics company bioMerieux S.A. (Euronext:BIM) will acquire BioFire Diagnostics Inc. (Salt Lake City, Utah) for $450 million in cash. bioMerieux also will assume an undisclosed amount of BioFire's net debt. BioFire develops and markets in...
07:00 , Aug 12, 2013 |  BC Week In Review  |  Clinical News

FilmArray Gastrointestinal Panel: Pivotal trial started

BioFire began a U.S. pivotal trial to evaluate the FilmArray Gastrointestinal Panel vs. stool culture and PCR testing followed by bi-directional sequencing in 1,500 stool specimens from patients with signs and/or symptoms of gastrointestinal illness....