BioFire Defense, a bioMérieux Company, Receives Prestigious Frost & Sullivan’s 2014 Global New Product Innovation Award for its FilmArray® Ebola Test

BioFire Defense, LLC is proud to announce that it is the recipient of the Frost & Sullivan’s 2014 Global New Product Innovation Award for its FilmArray® Ebola test. The New Product Innovation Award is given to companies that display strong overall performance in the development and market of an innovative new product, including adherence to U.S. Food and Drug Administration (FDA) criteria for Emergency Use Authorization (EUA)* and design of a product that addresses unmet needs.

The FilmArray® Ebola test (BioThreat-E testTM) runs on the BioFire FilmArray® system, a highly accurate and easy-to-use molecular diagnostic instrument which is currently used in hundreds of hospitals in the United States. The system delivers test results in one-hour, significantly reducing current testing time and allowing health professionals to make treatment decisions faster.

“The FilmArray® Ebola test which is rapid and easy-to-use will certainly be a great help for the healthcare professionals in the context of the Ebola outbreak. Diagnostics are a powerful force in improving patient care and I am honored to see the efforts of our team recognized by Frost & Sullivan,” said Kirk Ririe, CEO of BioFire Defense. “I am particularly proud to be part of bioMérieux whose development during more than 50 years has been driven by a pioneering spirit and unrelenting commitment to improve public health worldwide, backed by an extensive geographic footprint.”

A Frost and Sullivan analyst Srinivas Sashidhar declared: “BioFire Defense works closely with the U.S. Defense Department to proactively develop infectious disease molecular diagnostics for detecting emerging pathogens and biothreat agents, such as those responsible for Ebola virus disease and anthrax. This proactive approach is a key factor placing the company in a superior position to respond to the Ebola crisis in time.”

The Ebola virus epidemic is a global health emergency, and bioMérieux and BioFire are prepared to work with local authorities to ensure that this test is available in all countries that would need to use it for clinical testing.

Created over 20 years ago, BioFire has developed, produced and marketed a number of automated PCR molecular biology systems. More recently, BioFire developed FilmArray®, a unique CE-marked and FDA-cleared multiplex PCR system that integrates all molecular diagnostics steps - sample preparation, amplification, detection and analysis - into one system. As of today, the FilmArray® menu comprises three panels, the Respiratory Panel, the Blood Culture Identification Panel and the Gastro Intestinal Panel, all of which are CE-marked and FDA-cleared. Additionally, BioFire has initiated studies for its Meningitis-Encephalitis Panel, with FDA submission expected in 2015.

* The commercial BioThreat-E testTM is now available to high and moderate complexity clinical laboratories in the U.S. It is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus, unless the authorization is terminated or revoked sooner.”