FDA approved test catches novel rheumatoid arthritis markers before it's too late.
Bio-Rad's BioPlex 2200 Anti-CCP test received FDA clearance to launch, according to a press release.
The test is used for the early detection of rheumatoid arthritis and is manufactured by Bio-Rad Laboratories, Inc., a multinational manufacturer and distributor of life science research and clinical diagnostics products, and Axis-Shield plc, an international and innovative in vitro diagnostics (IVD) company.
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, in a press release. “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. It 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.
Bio-Rad Bio-Rad Laboratories, Inc. manufactures and distributes a broad range of products for the life science research and clinical diagnostic markets. 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.
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.
Do you plan on using the new test on your patients? How will earlier testing for rheumatoid arthritis affect treatment options?