Product News: Theradiag Receives CE Mark for New anti-CCP IVD Kit in Rheumatoid Arthritis

03 May 2013

Theradiag, a company specializing in theranostic and in vitro diagnostics, has announced it has obtained a CE mark for its proprietary anti-CCP in vitro diagnostic (IVD) kit in rheumatoid arthritis. This test further expands the Fidis portfolio of diagnostic tests for auto-immune diseases, which significantly decreases costs and analysis time, thanks to the Multiplex technology. Fidis is the most complete multiplex range of diagnostics currently marketed.

This new way of detecting anti cyclic citrullinated peptides (anti-CCPs) antibodies allows for highly-reliable detection of severe forms of RA through a more rapid dosing and at a lower cost than existing tests.

“This new CE mark shows our ability to further expand our high-value IVD portfolio. With this new addition to the Fidis range, we position ourselves as testing and monitoring leaders in auto-immune and inflammatory diseases. This anti-CCP test strengthens our in house products portfolio, in line with our development strategy. The new kits will be available internationally, like all our other Fidis products” commented Michel Finance, CEO of Theradiag.

The new anti-CCP test is the third proprietary diagnostic kit of Theradiag to obtain a CE mark this year. The auto-immune diseases segment grew strongly in 2012 (+17% for Fidis products), making-up for 43 percent of company sales in 2012.