Investigational Genetic Test May Help Address Common Problems in Prostate Cancer...( - Eight Studies Present...),Health

- Eight Studies Presented at Leading Urology Meeting Show that Simple Urine Test for PCA3 Gene May Improve Accuracy of Prostate Cancer Detection, Reduce Unnecessary Biopsies -

- Gen-Probe to Begin Pivotal Clinical Study in Effort to Gain U.S. Regulatory Approval -

SAN DIEGO, April 29 /PRNewswire-FirstCall/ -- Eight studies presented this week at the annual meeting of the American Urological Association (AUA) suggest that Gen-Probe's (Nasdaq: GPRO) investigational test for the highly specific prostate cancer gene PCA3 may help address some of the well-known challenges that urologists face when diagnosing prostate cancer, such as accurately identifying potentially aggressive cancers while minimizing "false positive" results that can lead to overtreatment.

In response to these studies and other promising data from approximately 17 peer-reviewed publications, Gen-Probe has decided to initiate a pivotal clinical study of its investigational PCA3 assay that could lead to regulatory approval by the U.S. Food and Drug Administration (FDA).

"Based on the results of our extensive clinical research studies and our European commercial experience, we believe that our PCA3 assay, when used in conjunction with other tests, can help predict the risk of a positive follow-up biopsy, thereby aiding in the diagnosis of prostate cancer," said Henry L. Nordhoff, Gen-Probe's chairman and chief executive officer. "We are pleased to be moving ahead with a U.S. clinical trial that could lead to improved patient care."

Gen-Probe's clinical study is expected to begin in the third quarter of 2009 and take about a year to complete. The Company anticipates it will involve more than 500 men, all of whom have had a negative prostate biopsy, at 10 or more clinical trial sites.

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