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.

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