Bio-Rad Laboratories and and Axis-Shield, an international in-vitro diagnostics (IVD) company, announced the launch of Bio-Rad’s BioPlex® 2200 Anti-CCP test for the early detection of rheumatoid arthritis.

The assay, which will run 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 kit is based on Axis-Shield’s proprietary anti-CCP technology. The assay is available for sale in certain countries outside the US.

"The anti-CCP testing market is one of the fastest growing markets in autoimmune diagnostics," said John Goetz, Bio-Rad Vice President and Group Manager of Clinical Diagnostics. "The addition of this assay will add significantly to our growing menu of autoimmune tests on the BioPlex 2200 system."

"We are very pleased that Bio-Rad has reached this important commercial milestone in our agreement and believe that availability on the BioPlex system will help expand the market for this important early marker for this debilitating condition," said Ian Gilham, Axis-Shield CEO. "The measurement of these antibodies has recently been cited as a key parameter in the definitive diagnosis of rheumatoid arthritis by the influential American College of Rheumatology."

The BioPlex 2200 system is a fully automated, random-access multiplex testing platform with an assay menu targeting autoimmune diagnostics and infectious diseases. In the US, the BioPlex 2200 Anti-CCP kit is pending clearance by the FDA.
Source: Axis-Shield and Bio-Rad Laboratories Inc