USDA Food Safety and Inspection Service Grants No Objection Letter for Bio-Rad’s Method for STEC Detection in Beef

Date: 
2012-12-06

Hercules, CA — December 6, 2012 — Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a multinational manufacturer and distributor of life science research and clinical diagnostic products, today announced that it has been granted a No Objection Letter by the United States Department of Agriculture Food Safety and Inspection Service (USDA FSIS) for its iQ-Check® real-time PCR method for the detection of Shiga toxin–producing Escherichia coli (STEC) bacteria in beef. Starting in June 2012, the USDA FSIS began testing for six new strains of STEC bacteria that were declared to be adulterants in beef trim in addition to the previously regulated E. coli O157:H7.

To substantiate the claims of the No Objection Letter, validation data were generated that demonstrated the equivalency of the Bio-Rad STEC method to the USDA MLG 5B.02 reference method in beef that was artificially inoculated with low levels of STEC bacteria as well as  E. coli O157:H7. As part of the submission to USDA FSIS, sensitivity and specificity evaluations were performed by the USDA Agricultural Research Service (USDA ARS) Eastern Regional Research Center in Wyndmoor, PA. 

“USDA ARS continually looks for opportunities to collaborate in ways that will expedite research to assist regulatory agencies and move technologies into the marketplace,” said Dr. Pina Fratamico, research leader with USDA ARS.

“The Bio-Rad STEC method was designed to be compatible with the USDA method,” said Brad Crutchfield, president of Bio-Rad’s Life Science Group. “We strive to provide fast, reliable, and easy-to-use solutions that enhance our customers’ food safety programs and allow them to feel confident in their decisions regarding food safety.

About iQ-Check
The iQ-Check STEC VirX and SerO kits that make up the STEC solution are based on the fast, sensitive, and proven technology of real-time PCR. They were designed specifically for the detection and identification of STEC bacteria in beef. Due to the sensitivity and specificity of PCR, results can be obtained after as little as 10–12 hours of enrichment. The iQ-Check kit range includes tests for detection of Campylobacter, Cronobacter, E. coli O157:H7, Listeria species, Listeria monocytogenes, Salmonella, and STEC.

About Bio-Rad
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) has remained at the center of scientific discovery for more than 50 years, manufacturing and distributing a broad range of products for the life science research and clinical diagnostic markets. The company is renowned worldwide among hospitals, universities, major research institutions, as well as biotechnology and pharmaceutical companies for its commitment to quality and customer service. Founded in 1952, Bio-Rad is headquartered in Hercules, California, and serves more than 100,000 research and industry customers worldwide through its global network of operations. The company employs over 7,100 people globally and had revenues exceeding $2 billion in 2011. For more information, visit www.bio-rad.com.

This release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally can be identified by the use of forward-looking terminology such as, “believe,” “expect,” “may,” “will,” “intend,” “estimate,” “continue,” or similar expressions or the negative of those terms or expressions. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. For further information regarding the Company's risks and uncertainties, please refer to the “Risk Factors” in the Company’s public reports filed with the Securities and Exchange Commission, including the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. Bio-Rad Laboratories, Inc., disclaims any obligation to update these forward-looking statements.

Press Contacts:

Bio-Rad Laboratories, Inc.
Tina Cuccia
Corporate Communications
510-724-7000
tina_cuccia@bio-rad.com