Healthcare Equipment and Supplies
Company Overview of BioFire Diagnostics, Inc.
BioFire Diagnostics, Inc., a clinical diagnostics company, develops, manufactures, and distributes molecular diagnostic systems to hospital-based clinical laboratories. The company offers high resolution melting instruments, high multiplex polymerase chain reaction (PCR) instrument, real-time PCR instruments, respiratory panels, freeze-dried reagents, food security reagents, reagent pouches, DNA and RNA sample purification kits, master mixes, and melting dyes solutions. Its products and services are used in the areas of bio-surveillance, food and water security testing, hi-resist melting for mutation discovery, and clinical diagnostic industries. In addition, the company provides bio-detecti...
390 Wakara Way
Salt Lake City, UT 84108
Founded in 1990
Key Executives for BioFire Diagnostics, Inc.
Chief Financial Officer and Treasurer
Senior Vice President of Biochemistry
Compensation as of Fiscal Year 2013.
BioFire Diagnostics, Inc. Key Developments
BioFire Diagnostics, LLC Submits 510(K) Application to FDA for FilmArray(R) Gastrointestinal Panel
Feb 18 14
BioFire Diagnostics, LLC announced that it has submitted the FilmArray Gastrointestinal (GI) Panel to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. The comprehensive FilmArray GI Panel tests for over 20 common bacteria, viruses and parasites that cause infectious diarrhea.
The submission of the FilmArray GI Panel comes after the successful completion of a clinical study that included more than 1,500 prospective samples. The study was conducted at several hospital-based clinical laboratories in the U.S. BioFire anticipates commercial release of the FilmArray GI Panel in early summer 2014, pending FDA clearance. Concurrently, the FilmArray GI Panel will receive CE marking. Despite advances in food safety, sanitation and medical treatment, infectious gastroenteritis remains a significant problem in industrialized countries among all age groups. In the United States, around 76 million cases of foodborne disease -- resulting in 325,000 hospitalizations and 5,000 deaths are estimated to occur each year. Current diagnostic practice requires choosing amongst multiple tests that can be laborious to perform and do not cover the breadth of pathogens that cause gastrointestinal illness. These tests are often carried out in a stepwise fashion, and the process can take too long to aid in timely pathogen-specific treatment decisions. Unlike open-platform testing that leaves labs vulnerable to cross-contamination, the FilmArray is a closed-system that integrates sample preparation, amplification and detection. With a run-time of about an hour and only two minutes of hands-on time, the FilmArray GI Panel is a comprehensive 23-target test that is performed directly from stool in transport media. Additionally, BioFire has initiated studies for its Meningitis Panel, with FDA submission expected in 2015.
BioFire Diagnostics, Inc. Presents at Utah Life Science Summit, Nov-06-2013 10:45 AM
Nov 3 13
BioFire Diagnostics, Inc. Presents at Utah Life Science Summit, Nov-06-2013 10:45 AM. Venue: Grand America Hotel, Salt Lake City, Utah, United States. Speakers: Randy Rasmussen, Co-Founder, President, Chief Operating Officer and Director.
BioFire Diagnostics, Inc., bioMérieux SA - M&A Call
Sep 3 13
To discuss bioMérieux SA agreement to acquire BioFire Diagnostics, Inc
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September 3, 2013