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Diagnostics FDA

 News Release - October 13, 2010

Bio-Rad and Axis-Shield Announce FDA Clearance and U.S. Launch of an Anti-CCP Test for Rheumatoid Arthritis for Bio-Rad's BioPlex 2200 System

HERCULES, CA and DUNDEE, SCOTLAND--(Healthcare Sales & Marketing Network) - Bio-Rad Laboratories, Inc. (NYSE:BIO ) and (NYSE:BIO.B ), a multinational manufacturer and distributor of life science research and clinical diagnostics products, and Axis-Shield plc (LSE:ASD ) (OSE:ASD ), an international and innovative in vitro diagnostics (IVD) company, today announced the U.S. Food and Drug Administration (FDA) clearance and U.S. launch of Bio-Rad's BioPlex® 2200 Anti-CCP test for the early detection of rheumatoid arthritis. The assay, which runs on Bio-Rad's BioPlex® 2200 system, measures anti-CCP (anti-cyclic citrullinated peptide antibodies), a novel marker that has been shown to have superior specificity in the diagnosis of rheumatoid arthritis. The BioPlex 2200 Anti-CCP assay is based on Axis-Shield's proprietary anti-CCP technology and was launched in territories outside the U.S. earlier in 2010.

"We are pleased to receive FDA clearance of our BioPlex 2200 anti-CCP assay as it allows us to expand our presence in the U.S. by offering a more compelling menu for infectious disease serology and autoimmune testing laboratories," said John Goetz, Bio-Rad Vice President and Group Manager of Clinical Diagnostics. "We believe the recent recommendation by the American College of Rheumatology and the European League Against Rheumatism to include anti-CCP in the definitive diagnosis of rheumatoid arthritis will further establish the growth of this important marker in autoimmune diagnostics."

"FDA market clearance for the anti-CCP test on Bio-Rad's novel BioPlex 2200 system represents an important milestone in the commercialization of the anti-CCP marker for rheumatoid arthritis," said Ian Gilham, Axis-Shield's Chief Executive Officer. "Test availability on this versatile analyzer represents the first time that anti-CCP has been offered on a multiplex autoimmune platform, and we believe this will encourage market expansion as the autoimmune nature of many conditions becomes increasingly recognized."

The BioPlex 2200 system is the first and only fully-automated, random access multiplex testing system and provides clinical laboratories with the capability to rapidly process or "multiplex" multiple individual tests that are traditionally processed separately. The BioPlex 2200 system conserves patient sample volume, consolidates workstations, and simplifies workflow.

About Bio-Rad

Bio-Rad Laboratories, Inc. (NYSE:BIO ) and (NYSE:BIO.B ) 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 85,000 research and industry customers worldwide through its global network of operations. The company employs over 6,800 people globally and had revenues of nearly $1.8 billion in 2009. For more information, please visit

About Axis-Shield

Axis-Shield is an international and innovative in vitro diagnostics company, headquartered in Dundee with R&D and manufacturing bases in Dundee and Oslo. The Group specializes in the supply of instruments and tests for the rapidly growing physician's office testing market and the development, manufacture and marketing of innovative proprietary diagnostics kits in areas of clinical need, including cardiovascular and neurological diseases, rheumatoid arthritis, and diabetes. For more information on Axis-Shield, please refer to

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.

Source: Bio-Rad Laboratories

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