BioFire Awarded Next Generation Diagnostics System Contract
BioFire Diagnostics, Inc. today announced that it has signed a competitive prototyping contract with the Department of the Army
SALT LAKE CITY, Utah (March 26, 2013) – BioFire Diagnostics, Inc. today announced that it has signed a competitive prototyping contract with the Department of the Army for Increment 1 of the Next Generation Diagnostics System (NGDS) Program. NGDS is being developed by the Chemical Biological Medical Systems Biosurveillance (CBMS-BSV) Joint Product Management Office of the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) to provide an FDA-cleared diagnostic system for the analysis of clinical and environmental biological warfare (BW) agent samples. The system will provide military healthcare providers with timely and accurate information to guide individual patient treatment as well as provide battlefield commanders with BW threat information for situational awareness to support Force Protection.
Kirk Ririe, Chief Executive Officer of BioFire Diagnostics, stated, “BioFire has a history of successful developmental efforts with the United States Department of Defense, most notably with the JBAIDS program, and we are excited for this opportunity to demonstrate the capabilities of the FilmArray®. The FilmArray System, along with its comprehensive syndromic panels, is capable of supporting the Department of Defense’s efforts to protect the Warfighter from environmental BW agent threats as well as clinical threats, especially since the FilmArray Instrument and Respiratory Panel have previously received FDA clearance.”
For Increment 1, BioFire will develop a FilmArray panel that will be optimized to detect BW agents in blood or environmental samples. The FilmArray System will be evaluated during the Competitive Prototyping Phase and if selected, BioFire will receive a final contract to be awarded later in the year for further system development and obtaining FDA clearance for the BW agent panel.
The FilmArray is a user-friendly, FDA-cleared multiplex PCR System that integrates sample preparation, amplification, detection and analysis into a single instrument. Only two minutes of hands-on time is required to test a sample against a comprehensive panel of pathogen targets. Currently available is an FDA-cleared Respiratory Panel that tests for 17 viral and 3 bacterial disease agents. Also available is a research use only (RUO) BioThreat panel that tests environmental samples for 17 CDC-defined Category A and B bioterrorism agents. BioFire continues to develop a broad test menu for the system, including a Blood Culture ID Panel, Gastrointestinal Panel and a Meningitis Panel.
About The Chemical Biological Medical Systems Joint Project Management Office
The CBMS-Joint Project Management Office is part of the DoD’s Joint Program Executive Office for Chemical and Biological Defense. Chartered in 2003, CBMS provides the Warfighter with safe, robust, affordable medical countermeasures against a broad spectrum of Chemical Biological Radiological and Nuclear (CBRN) threats. The CBMS-JPMO uses government and commercial best practices to acquire FDA-approved CBRN medical countermeasures and diagnostics. The CBMS-JPMO is comprised of a headquarters and support element and three Joint Product Management Offices: the Joint Vaccine Acquisition Program, Medical Identification and Treatment Systems, and Biosurveillance.
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 FilmArray RP, which operates on the user-friendly, patented FilmArray system, to hospital-based clinical laboratories across the U.S. and EU. With the FilmArray RP, BioFire provides the only FDA-cleared clinical diagnostic test for eight of the 20 organisms in its panel.
BioFire holds more than 85 patents related to polymerase chain reaction (PCR), and it 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, clinical laboratories, and research institutions across a spectrum of fields and industries around the world.
For further information, please visit www.BioFireDx.com.
BioFire Diagnostics, Inc.
BioSurveillance Marketing Manager