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Gen-Probe receives FDA approval for PROGENSA PCA3 assay

PBR Staff Writer Published 16 February 2012

Gen-Probe has received FDA approval for PROGENSA Prostate Cancer gene 3 (PCA3) assay, a urine-based molecular test to help determine need for repeat prostate biopsies.

The assay aids in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies

The test is indicated for whom a repeat biopsy would be recommended by a urologist based on the current standard of care, before consideration of PROGENSA PCA3 assay results.

A negative PROGENSA PCA3 assay result is associated with a decreased likelihood of a positive biopsy.

A prostate biopsy is required to diagnose cancer, the company said.

Gen-Probe chairman and CEO Carl Hull said when used in conjunction with other diagnostic information, PROGENSA PCA3 assay provides clinically important information that helps make better decisions about prostate cancer diagnosis.