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ARTICLE | Clinical News

CPAPP-A* test: Pivotal trial data

August 20, 2012 7:00 AM UTC

Beckman Coulter Inc. reported data from an analysis of 3,782 patients with non-ST-segment-elevation myocardial infarction (NSTEMI) ACS in the double-blind, placebo-controlled, international Phase III MERLIN-TIMI 36 trial of Ranexa ranolazine to treat ACS showing that patients with PAPPA levels of >=6 µIU/mL at baseline (n=644) as measured by the company's cPAPP-A* test had significantly higher rates of cardiovascular death or MI at 30 days (7.4% vs. 3.7%, p<0.001) and at 1 year (14.9% vs. 9.7%, p<0.001) compared to patients with baseline PAPPA levels of <6 µIU/mL. Data were published in the Journal of the American College of Cardiology. Beckman, which was acquired by Danaher in 2011, said it plans to seek regulatory approval of the cPAPP-A* assay in the U.S. and EU, but did not disclose a time frame. ...