NEW YORK (GenomeWeb News) – Gen-Probe this week said that it has begun a clinical study of its Progensa PCA3 assay, a molecular test for determining the need for a repeat prostate biopsy. The firm said that the trial would be conducted to support an application to the US Food and Drug Administration for clearance of the assay.
Gen-Probe said that it expects to enroll around 500 men, all of whom have had a negative prostate biopsy, at 10 or more clinical trial sites. It expects the trial to conclude in less than a year, after which it will file the application with FDA.
CardioDx this week said that it had completed a multi-center validation study for its Corus CAD gene expression test for quantifying the likelihood of obstructive coronary artery disease in patients with stable chest pain. The firm said it would publish the result of the study next year. In the meantime, it has made the test available in nine states through its CLIA-certified lab in Palo Alto, Calif., with more states expected to be added in 2010.
A Scripps Florida researcher is collaborating with the West Palm Beach, Fla.-based Hanley Center and the Florida Department of Health on developing a new blood test to predict the risk of relapse in patients with addictions. The researcher, Paul Kenny, will analyze blood samples from patients at the Hanley Center for specific biomarkers that may accurately predict relapse.