August 20, 2017 4:58 AM ET

Healthcare Equipment and Supplies

Company Overview of BioFire Diagnostics, LLC

Company Overview

BioFire Diagnostics, LLC provides clinical molecular diagnostic solutions for clinics and laboratories. It offers FilmArray, a multiplex PCR system that sets the standard for syndromic infectious disease molecular diagnostics; FilmArray Torch, a random access system that is designed to meet laboratory’s syndromic infectious disease testing needs; and panels. BioFire Diagnostics, LLC was formerly known as Idaho Technology, Inc. and changed its name in August 2012. The company was founded in 1990 and is headquartered in Salt Lake City, Utah. As of January 6, 2014, BioFire Diagnostics, LLC operates as a subsidiary of bioMérieux SA.

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, 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: 63
Senior Vice President of Biochemistry
Compensation as of Fiscal Year 2017.

BioFire Diagnostics, LLC Key Developments

BioFire Diagnostics, LLC Receives Clearances from the U.S. Food and Drug Administration (FDA) to Market the FilmArray® Torch

bioMérieux announced that BioFire Diagnostics, LLC, its molecular biology affiliate, has received clearances from the U.S. Food and Drug Administration (FDA) to market the FilmArray® Torch for use with the FilmArray®Blood Culture Identification (BCID) Panel, Gastrointestinal (GI) Panel, and Meningitis/Encephalitis (ME) Panel. FilmArray® Torch already received FDA clearance for use with the FilmArray®Respiratory Panel (RP) in February 2016. At the same time, FilmArray® Torch gets CE marked. BioFire will introduce FilmArray® Torch at the ECCMID (European Congress of Clinical Microbiology and Infectious Diseases – Amsterdam April 9-12, booth #85 Hall D) and anticipates commercial availability of FilmArray® Torch this summer in the United States and this fall in Europe. The FilmArray® Torch provides up to six times more sample throughput per square foot of benchtop space. The high throughput system is a fully integrated, random and continuous access multiplex PCR1 system designed to meet the throughput demands of any size clinical laboratory. FilmArray® is a multiplex PCR system that integrates sample preparation, amplification, and detection into one closed system. The FilmArray® requires only two minutes of hands-on time and has a total run time of about an hour. The FilmArray® RP is a comprehensive panel of 20 respiratory viruses and bacteria that is performed directly on nasopharyngeal swab-associated viral transport media. The FilmArray®BCID Panel is capable of identifying 27 of the most common causes of bloodstream infections and antimicrobial resistance directly from positive blood culture. The FilmArray®GI Panel identifies 22 of the most common causes of infectious diarrhea directly from stool in transport media. The FilmArray®ME Panel is capable of identifying 14 bacterial, viral, and fungal causes of meningitis and encephalitis directly from cerebrospinal fluid.

BioFire Diagnostics, LLC Receives FDA Clearance for FilmArray Torch with FilmArray Respiratory Panel and Submits Special 510(K) Applications for Use with Additional FilmArray Panels

bioMérieux announced that BioFire Diagnostics, LLC, its molecular biology affiliate, has received Special 510(k)1clearance from the U.S. Food and Drug Administration (FDA) to market the FilmArray Torch for use with the FilmArray Respiratory Panel (RP), and has submitted special 510(k) applications for use with additional FilmArray panels which include Blood Culture Identification, Gastrointestinal and Meningitis/Encephalitis Panels. BioFire anticipates commercial availability of FilmArray Torch this summer in the United States and in the second half of 2016 in Europe. The FilmArray Torch is the latest advancement in syndromic infectious disease testing from BioFire Diagnostics. Providing up to six times more sample throughput compared to the existing system, 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. FilmArray is a multiplex PCR system that integrates sample preparation, amplification, and detection into one closed system. The FilmArray requires only two minutes of hands-on time and has a total run time of about an hour. In 2015, the rapid growth of the revenue and of the installed base reaching about 2,500 instruments, confirmed the success of FilmArray in the molecular syndromic approach of infectious diseases.

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.

Similar Private Companies By Industry

Company Name Region
.decimal, Inc. United States
20/20 GeneSystems Inc. United States
20/20 Imaging LLC United States
21st Century Scientific, Inc. United States
21X Corporation United States

Recent Private Companies Transactions

Type
Date
Target
No transactions available in the past 12 months.
\
 

The information and data displayed in this profile are created and managed by S&P Global Market Intelligence, a division of S&P Global. Bloomberg.com does not create or control the content. For inquiries, please contact S&P Global Market Intelligence directly by clicking here.

Stock Quotes

Market data is delayed at least 15 minutes.

Company Lookup

Most Searched Private Companies

Company Name Geographic Region
Lawyers Committee for Civil Rights Under Law United States
NYC2012, Inc. United States
The Advertising Council, Inc. United States
Bertelsmann AG Europe
Rush University United States

Sponsored Financial Commentaries

Sponsored Links

Request Profile Update

Only a company representative may request an update for the company profile. Documentation will be required.

To contact BioFire Diagnostics, LLC, please visit www.biofiredx.com. Company data is provided by S&P Global Market Intelligence. Please use this form to report any data issues.

Please enter your information in the following field(s):
Update Needed*

All data changes require verification from public sources. Please include the correct value or values and a source where we can verify.

Your requested update has been submitted

Our data partners will research the update request and update the information on this page if necessary. Research and follow-up could take several weeks. If you have questions, you can contact them at bwwebmaster@businessweek.com.