07:00 , Apr 29, 2013 |  BC Week In Review  |  Clinical News

Anti-CCP IVD kit regulatory update

Theradiag said it received CE Mark approval for its anti- cyclic citrullinated peptide (anti-CCP) antibodies in vitro diagnostic (IVD) kit to detect rheumatoid arthritis (RA). The company said the kit will be available worldwide. Theradiag...
07:00 , Oct 31, 2011 |  BC Week In Review  |  Company News

Axis-Shield, Siemens deal

Axis-Shield granted Siemens' Siemens Healthcare Diagnostics unit a non-exclusive, worldwide license to develop Axis-Shield's anti-CGP test for early detection of rheumatoid arthritis (RA) to run on Siemens' automated Siemens ADVIA Centaur Immunoassay System. Axis-Shield's ELISA...
07:00 , Oct 18, 2010 |  BC Week In Review  |  Clinical News

BioPlex 2200 Anti-CCP test regulatory update

FDA granted 510(k) clearance to Bio-Rad's BioPlex 2200 Anti-CCP test for the early detection of rheumatoid arthritis. Bio-Rad said it also launched the test in the U.S. and already markets it outside the U.S. The...
07:00 , Jul 26, 2010 |  BC Week In Review  |  Clinical News

Adipose-derived stem cells autoimmune data

In a 67-year old female patient with RA, 2 IV infusions totaling 53 million autologous adipose-derived SVF cells led to "considerable" resolution of joint pain and stiffness following the second infusion. Additionally, the patient began...
07:00 , Jun 28, 2010 |  BC Week In Review  |  Company News

Axis-Shield, Bouty Healthcare S.p.A. sales and marketing update

Bouty's Technogenetics s.r.l. division launched an automated anti-CCP test outside the U.S. for the early detection of rheumatoid arthritis (RA). The assay, which measures anti-cyclic citrullinated peptide antibodies, is based on technology from Axis-Shield and...
08:00 , Jan 11, 2010 |  BC Week In Review  |  Company News

Bio-Rad Laboratories sales and marketing update

Bio-Rad launched its BioPlex 2200 Anti-CCP test in Australia, Canada, France, Israel, South Africa and the U.K. to detect rheumatoid arthritis. The assay, which measures anti-cyclic citrullinated peptide antibodies (anti-CCP), will run on Bio-Rad's BioPlex...
07:00 , Oct 26, 2009 |  BC Week In Review  |  Clinical News

Orencia abatacept: Additional Phase IIIb data

The 1-year open-label extension period of the Phase IIIb AGREE trial in 459 patients showed that Orencia plus methotrexate resulted in 55.2% patients with a DAS28-CRP <2.6 at 24 months. ACR50 and ACR70 scores for...
08:00 , Mar 2, 2009 |  BC Week In Review  |  Clinical News

DIASTAT anti-CCP assay regulatory update

The U.K.'s NICE issued guidance on the management of rheumatoid arthritis in adults recommending measurement of anti-cyclic citrullinated peptide (CCP) antibodies in patients with suspected RA who are negative for rheumatoid factor and in whom...
08:00 , Nov 3, 2008 |  BC Week In Review  |  Clinical News

Orencia abatacept: Phase IIIb data

In a double-blind, Phase IIIb trial in 509 patients with early erosive RA, Orencia plus methotrexate met the primary endpoint of a significant improvement in DAS28 remission vs. methotrexate plus placebo (41% vs. 23%, p<0.001)....
07:00 , Jun 23, 2008 |  BC Week In Review  |  Clinical News

Orencia abatacept: Phase II data

Data from 50 evaluable patients with inflammatory arthritis in a double-blind, Phase II trial showed that 12 of 26 patients receiving Orencia developed RA at 1 year vs. 16 of 24 patients receiving placebo. The...