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FDA approves Gen-Probe's prostate cancer diagnostic test

FDA approves Gen-Probe's prostate cancer diagnostic test

Gen-Probe (NASDAQ:GPRO) said Wednesday U.S. health regulators approved its diagnostic test Progensa PAC3 which is used to verify the need for repeat biopsies in men at risk of getting prostate cancer.

The company, founded in 1983 and with about 1,363 employees, makes molecular diagnostic products and services to diagnose diseases and screen donated blood.

Gen-Probe acquired worldwide diagnostics rights to the biomarker Prostate Cancer Antigen 3 (PAC3) gene from DiagnoCure (TSE:CUR) in 2003.

The FDA approval was backed by a clinical study launched in August 2009 and finished in May 2010. The study enrolled 495 men at 14 clinical sites. Gen-Probe submitted their premarket approval application to the FDA in August 2010.

In the clinical study, the PAC3 assay had a negative predictive value of 90 percent, meaning a negative PCA3 assay result predicted a negative prostate biopsy 90 percent of the time.

The PCA3 gene test – carried out through urine samples taken after a digital rectal examination – is highly over-expressed in more than 90 percent of prostate cancers.  The test is the first urine-based molecular diagnostic test for prostate cancer.

"Over-expression of the PCA3 gene is highly specific to cancerous prostate tissue," said John Wei professor of urology at the
University of Michigan Health System. 

"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."

Prostate cancer usually consists of several primary tumours located in the prostate. If left untreated, prostate cancer cells may
continue to grow and could spread to other parts of the body and produce secondary tumours.

San Diego, California-based Gen-Probe noted that the Progensa PCA3 assay is indicated for use along with other patient information to assist in the decision for repeat biopsy in men aged 50 or older who have had one or more previous negative prostate biopsy.

A negative PCA3 assay result is associated with a decreased likelihood of a positive biopsy. A prostate biopsy is needed to diagnose cancer, the company said.

The company said that the Progensa PCA3 assay should not be used for men with atypical small acinar proliferation on their most recent biopsy.

According to the American Cancer Society, prostate cancer is the second most common type of cancer found in American men.

About 241,000 cases were newly diagnosed in 2011, of which roughly 34,000 med died from the disease.

Shares were down 0.13 percent to $69.69 apiece Wednesday on the Nasdaq.

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