Axis-Shield's anti-CCP kit approved in Japan

Scotland-headquartered in vitro diagnostics company Axis-Shield says that its Japanese partner, MBL, has received Ministry of Health Labor and Welfare approval to market its patented anti-CCP assay for early detection of rheumatoid arthritis in Japan.

As anti-CCP is a novel marker, MBL had to register the product as a "New Item," and it is believed that, in the absence of an existing comparable test, the high diagnostic accuracy of the anti-CCP assay, coupled with its prognostic utility in disease management, helped to persuade the regulators to approve the product, says the Scottish firm. MBL plans to market the kit as an IVD reagent in early 2007 and formal product reimbursement is projected for later in the year.