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February 11, 2016 2:45 AM ET

Healthcare Equipment and Supplies

Company Overview of BioFire Diagnostics, LLC

Company Overview

BioFire Diagnostics, LLC 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-detection training; instrument accessorie...

390 Wakara Way

Salt Lake City, UT 84108

United States

Founded in 1990





Key Executives for BioFire Diagnostics, LLC

Co-Founder, Chief Executive Officer and Director
Co-Founder, President, Chief Operating Officer and Director
Co-Founder and Chairman
Chief Financial Officer and Treasurer
Age: 61
Senior Vice President of Biochemistry
Compensation as of Fiscal Year 2015.

BioFire Diagnostics, LLC Key Developments

BioFire Submits Special 510(k) Application to the FDA for the use of FilmArray® Torch, the New High Throughput FilmArray® System with FilmArray® Respiratory Panel

bioMérieux announced that BioFire Diagnostics, LLC has submitted the FilmArray® Torch to the U.S. Food and Drug Administration (FDA) for special1 510(k) clearance for use with the FilmArray®Respiratory Panel (RP). The FilmArray® Torch is the latest advancement in syndromic infectious disease molecular testing from BioFire Diagnostics. Providing up to six times more sample throughput per square foot of benchtop space, the high throughput FilmArray® Torch is a fully integrated, random and continuous access multiplex PCR2 system, designed to meet the throughput demands of any size hospital laboratory. Scalable by design, the 2-module base configured FilmArray® Torch is capable of testing up to 42 patient samples per day, while the 12-module, fully configured FilmArray® Torch is capable of testing up to 262 patient samples per day3. With intuitive instrument control, an integrated barcode scanner, touchscreen interface, and FilmArray® Link technology, the FilmArray® Torch delivers an optimized user experience and seamless integration into laboratory information systems.

LABSCO Enters an Exclusive Partnership with Biofire Diagnostics

LABSCO, announced that effective May 01, 2015, it will serve BioFire Diagnostics, a molecular biology affiliate of bioMérieux, as an exclusive sales agent partner in specified labs in the 48 contiguous United States. Market segments covered by LABSCO will be small hospital laboratories and physician office laboratories as the FilmArraysystem is certified CLIA moderate complexity. LABSCO will be responsible for selling, account management, local marketing and contract presentation/execution for transition contracts and new contracts. FilmArray’s menu currently comprises three panels – respiratory, blood culture identification and gastrointestinal – all of which are CE-marked and FDA-cleared. Additionally, BioFire has submitted a de novo application to the FDA for its Meningitis-Encephalitis panel. The new partnership between BioFire and LABSCO can offer solutions to help healthcare professionals overcome these challenges.

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.

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