October 23, 2014 4:45 AM ET

Healthcare Equipment and Supplies

Company Overview of BioFire Diagnostics, Inc.

Company Overview

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

United States

Founded in 1990

Phone:

801-736-6354

Fax:

801-588-0507

Key Executives for BioFire Diagnostics, Inc.

Co-Founder
Co-Founder
Co-Founder and Chairman
Chief Financial Officer and Treasurer
Age: 60
Senior Vice President of Biochemistry
Compensation as of Fiscal Year 2014.

BioFire Diagnostics, Inc. Key Developments

BioFire's FilmArray(R) Gastrointestinal Panel Receives FDA Clearance

bioMérieux announced that BioFire, its new molecular biology affiliate, received U.S. Food and Drug Administration (FDA) 510(k) clearance for the FilmArray(R) Gastrointestinal (GI) Panel. The 22-target FilmArray(R) GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. It is the most comprehensive gastrointestinal test to be cleared by the FDA and contains several pathogens receiving FDA clearance for the first time. Current diagnostic practice requires choosing among 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(R) is a closed-system that integrates sample preparation, amplification and detection. In addition, the FilmArray(R) GI Panel is performed directly from stool in Cary Blair transport media, takes only two minutes to set up, and produces results in about an hour. The FilmArray(R) GI Panel is a user-friendly alternative to the time-consuming, labor intensive, costly and technically complex testing methods used now and improves accuracy, timeliness and diagnostic yield for all 3 pathogen types. 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, between 200 and 375 million episodes of diarrheal illness are estimated to occur each year, resulting in 73 million physician visits, 1.8 million hospitalizations, 3,100 deaths and $6 billion in medical care and lost productivity. Early diagnosis facilitates timely and appropriate therapeutic interventions that can alleviate symptoms and prevent secondary infections. In addition, rapid determination of the exact cause will assist in managing contacts and stopping the transmission of the pathogens which are contagious, thereby contributing to improved Public Health.

BioFire Diagnostics, LLC Submits 510(K) Application to FDA for FilmArray(R) Gastrointestinal Panel

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

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.

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