, Sept. 21
/PRNewswire-FirstCall/ -- Gen-Probe (Nasdaq: GPRO) announced today that the Company has submitted a Premarket Approval Application (PMA) to the US Food and Drug Administration (FDA) for its PROGENSA® PCA3 assay, a new molecular test that may help determine the need for repeat biopsies in men suspected of having prostate cancer.
"Based on the results of our US clinical study, data from numerous peer-reviewed publications, and our European commercial experience, we believe the PROGENSA PCA3 assay can help determine the need for repeat prostate biopsies, thereby improving patient care," said Carl Hull, Gen-Probe's president and chief executive officer. "In addition, this regulatory submission represents the second of four that we expect to complete in the United States this year. Together, these new products will start an important new sales growth cycle for the Company."
Gen-Probe is seeking FDA approval to use the PROGENSA PCA3 assay to test urine samples from men who previously have had a negative prostate biopsy. In support of this objective, the Company conducted a prospective, multicenter clinical study of the assay that enrolled 507 men. The trial began in August of 2009 and concluded in May of 2010. Gen-Probe intends to present the results of the study at a future medical meeting.
The FDA has formally filed Gen-Probe's PMA, and has advised the Company that a meeting of the Medical Devices Advisory Committee's Immunology Panel will be required to support approval of the PMA. No date for this meeting has been set.
About Prostate Cancer and PCA3
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 36 will die from it. The ACS estimates that about 218,000 Americans will be newly diagnosed with prostate cancer in 2010, and that approximately 32,000 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.
Data from approximately 30 peer-reviewed publications suggest that PCA3 testing, when used with other patient information, may help address some of the well-known challenges urologists face when identifying prostate cancer, such as identifying clinically relevant cancers that need to be treated while minimizing unnecessary biopsies.
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.
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective molecular diagnostic products and services that are used primarily to diagnose human diseases, screen donated human blood, and ensure transplant compatibility. Gen-Probe has approximately 27 years of expertise in nucleic acid testing (NAT), 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 1,300 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, 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 an FDA advisory panel will not recommend our PCA3 test; (ii) the risk that our PCA3 test will not be approved for marketing in the timeframe 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.
Vice president, investor relations and corporate communications