BioFire Defense, a bioMérieux company, receives fast-track authorization of FilmArray® Ebola Test

Regulatory News :

bioMérieux (Paris:BIM) :

BioFire Defense, LLC of Salt Lake City, UT announced today that it has received Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) for its commercial FilmArray^® Ebola test (BioThreat-E test^TM).

The test runs on the BioFire FilmArray^® system, a highly accurate, fast, and easy-to-use PCR^* 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.

"This EUA and FilmArray^® test for Ebola are the result of a long collaboration and close working relationship with U.S. Department of Defense. The FDA has been an excellent working partner providing the feedback needed to ensure the efficacy of such an important diagnostic test,” said Kirk Ririe, CEO of BioFire Defense. "It is our mission to help improve public health and the rapid turnaround and ease-of-use of FilmArray^® will certainly be a great help for the healthcare professionals in the context of the Ebola outbreak.”

The commercial BioThreat-E test^TM 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.

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

ABOUT BIOMERIEUX

Pioneering diagnostics

A world leader in the field of in vitro diagnostics for 50 years, bioMérieux is present in more than 150 countries through 41 subsidiaries and a large network of distributors. In 2013, revenues reached €1,588 million with 87% of sales outside of France.

bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

bioMérieux is listed on the NYSE Euronext Paris market.(Symbol: BIM - ISIN: FR0010096479).

Corporate website: www.biomerieux.com - Investor website: www.biomerieux-finance.com.

ABOUT BIOFIRE DEFENSE

BioFire Defense, LLC, formerly Idaho Technology, Inc., is a subsidiary of bioMerieux Inc. (Durham, NC) and is based in Salt Lake City, Utah. BioFire Defense is focused on technology innovation and product development of pathogen identification and the life science applications. It has developed and provided products for defense, food testing, and the life sciences since 1990.

BioFire Diagnostics, LLC, its sister subsidiary, continues delivering and expanding the clinical applications of the FilmArray System to hospital-based clinical laboratories across the world.