Date: Jul 30, 2013 Source: Business Wire (
click here to go to the source)
Panel will be third diagnostic test to run on the FilmArray system
SALT LAKE CITY--(BUSINESS WIRE)--
BioFire Diagnostics, Inc., recently announced that it has commenced clinical and analytical studies to evaluate the company's FilmArray Gastrointestinal (GI) Panel, with plans to seek both CE IVD marking and FDA clearance.
The comprehensive 23-target panel tests for common bacteria, viruses and protozoa that cause infectious diarrhea. The test is performed in about an hour directly from stool in transport media.
"With the commencement of our GI studies, we continue to expand our FilmArray clinical diagnostic test menu," said Kirk Ririe, CEO of BioFire. "We are expecting very encouraging results, and our continued advancement in diagnostic testing is a reflection of BioFire's passion for creating breakthrough solutions that improve health and advance science."
BioFire plans to launch the GI panel in the second half of 2014 in both the U.S. and Europe. The GI Panel will be the third clinical diagnostic test to run on the company's FilmArray system.
The clinical study is being conducted at several hospital-based clinical laboratories in the U.S. and is funded by an NIH R01 grant.
About BioFire Diagnostics, Inc.
BioFire Diagnostics, Inc., formerly Idaho Technology, Inc., is a privately held clinical diagnostics company based in Salt Lake City, Utah. The company manufactures and distributes the user-friendly FilmArray system to hospital-based clinical laboratories across the U.S. and EU. BioFire currently offers the FilmArray Respiratory (RP) Panel and the Blood Culture Identification (BCID) Panel, both FDA-cleared and CE IVD marked. The FilmArray system is a significant advancement in user-friendliness and multiplex infectious disease testing capability for hospital clinical labs. Requiring only two minutes of hands-on time, the FilmArray system has about a 1-hour turnaround time, and each panel simultaneously tests for 20+ pathogens.
BioFire holds more than 85 patents related to polymerase chain reaction (PCR), and has used its extensive patent portfolio to successfully market nearly 200 products to the clinical, research and military markets. BioFire customers include the Department of Health and Human Services, the Department of Defense, state and local law enforcement, researchers and medical technicians across a spectrum of fields and industries.
For further information, please visit www.BioFireDx.com.
Contact:
BioFire Diagnostics, Inc.
Wade Stevenson, 801-736-6354 x463
