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Gen-Probe to File PMA for PCA3 Assay; Possible Alternative to PSA

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By Turna Ray

By mid-2010 Gen-Probe plans to submit a premarket approval application to the US Food and Drug Administration for a new molecular diagnostic that may help doctors identify men at increased risk of prostate cancer.

Gen-Probe announced last week that it has begun a clinical trial for its Progensa PCA3 assay, enrolling 500 men who have had a negative prostate biopsy. The clinical trial will be run at 10 or more sites. The study is slated to complete in less than a year, at which point the company expects to submit its PMA to the FDA.

According to the company, data from more than 20 peer-reviewed publications suggest that the Progensa PCA3 assay, when used in conjunction with other clinical information, "may help address some of the well-known challenges urologists face when identifying prostate cancer, such as minimizing unnecessary biopsies."

The Progensa PCA3 assay is CE-marked in the European Union, and according to Gen-Probe it is the first urine-based molecular diagnostic assay for prostate cancer.

"Based on the results of our extensive clinical research studies and our European commercial experience, we believe that our Progensa PCA3 assay can help predict the risk of a positive follow-up biopsy, thereby improving patient care," said Eric Lai, Gen-Probe's senior VP of research and development, in a statement.

In a study by Chun et al. published earlier this year in European Urology, researchers concluded that PCA3 is "a novel marker capable of increasing predictive accuracy of multivariate biopsy models," and developed a nomogram that "better identifies men at risk of harboring prostate cancer and assists in deciding whether further evaluation is necessary." The study was conducted by researchers at the University Hospital Hamburg-Eppendorf in Germany.

Researchers have previously identified PCA3 as a gene that is over-expressed in more than 90 percent of prostate cancers. The gene expression can be quantified in urine specimens following a digital rectal examination.

"Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen testing," the company said in a statement.

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