Gen-Probe Begins U.S. Clinical Study of PROGENSA(R) PCA3 Assay, New Molecular Test to Help Assess Prostate Cancer Risk
SAN DIEGO, Aug. 27 /PRNewswire-FirstCall/ — Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the Company has begun a clinical trial intended to secure U.S. regulatory approval of its PROGENSA(R) 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 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(R) 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 (TSX: CUR) in November of 2003.
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has more than 25 years of NAT expertise, and received the 2004 National Medal of Technology, America’s highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 1,200 people. For more information, go to www.gen-probe.com.
Caution Regarding Forward-Looking Statements
Any statements in this press release about Gen-Probe’s expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning new products, potential regulatory approvals, customer adoption, and results of future clinical studies are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections contained in the forward-looking statements include but are not limited to: (i) the risk that clinical trial results for our PCA3 test will not be favorable; (ii) the risk that our PCA3 test will not be approved for marketing in the timeframes we expect, if at all; (iii) the possibility that the market for the sale of our PCA3 product may not develop as expected; (iv) the risk that we may not be able to compete effectively; (v) the risk that we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts; and (vi) the risk that third parties may not distribute our products effectively. The foregoing describes some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. For additional information about risks and uncertainties Gen-Probe faces and a discussion of the Company’s financial statements and footnotes, see documents filed with the SEC, including the most recent annual report on Form 10-K and all subsequent periodic reports. We assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.
Contact: Michael Watts Vice president, investor relations and corporate communications 858-410-8673
SOURCE Gen-Probe Incorporated