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FDA approves Gen-Probe Progensa PCA3 assay

The US Food and Drug Administration (FDA) has approved Gen-Probe's Progensa PCA3 assay.

Gen-Probe chairman and CEO Carl Hull said Progensa PCA3 assay when used in conjunction with other diagnostic information provides clinically important information that helps physicians and their patients make better, more informed decisions about one of the most vexing problems in prostate cancer diagnosis.

University of Michigan Health System Urology professor John Wei said over-expression of the PCA3 gene is highly specific to cancerous prostate tissue.

"When evaluated with other risk factors, the Progensa PCA3 assay fills an important unmet clinical need by helping physicians identify which men suspected of having prostate cancer should undergo a repeat prostate biopsy," Wei said.