New Molecular Test to Help Assess Prostate Cancer Risk

Gen-Probe Incorporated (San Diego, CA), a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs), announced late last week that the Company has begun a clinical trial intended to secure U.S. regulatory approval of its PROGENSA PCA3 assay, a new molecular test that may help determine the need for a repeat prostate biopsy.

"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, PhD, Gen-Probe's senior vice president of research and development. "In addition, this is an important step forward in our efforts to maximize the economic value of our oncology strategy."

The clinical study of the PROGENSA PCA3 assay is expected to conclude in less than a year, after which Gen-Probe intends to submit a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration. The Company anticipates the trial will enroll approximately 500 men, all of whom have had a negative prostate biopsy, at 10 or more clinical trial sites.

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

According to the American Cancer Society (ACS), prostate cancer is the second most common type of cancer found in American men (behind skin cancer), and the second-leading cause of cancer death in men (after lung cancer). One in six American men will get prostate cancer during his lifetime, and one in 35 will die from it. The ACS estimates that more than 192,000 Americans will be newly diagnosed with prostate cancer in 2009, and that more than 27,000 men will die from the disease.

PCA3, over-expressed in prostate cancer
PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that 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 (PSA) testing.

Gen-Probe's PROGENSA PCA3 assay, which has been CE-marked for sale in the European Union, is the first urine-based molecular diagnostic assay for prostate cancer. The test has not been approved for marketing in the United States.

Gen-Probe acquired exclusive worldwide diagnostic rights to the PCA3 gene from DiagnoCure in November of 2003.

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