Gen-Probe Receives Canadian Regulatory Approval for PROGENSA(R) PCA3 Assay, New Molecular Urine Test to Help Determine Need for Repeat Prostate Biopsies
-- Diagnostic Rights to Biomarker Acquired from Quebec-Based DiagnoCure --
SAN DIEGO, Aug. 17, 2011 /CNW/ - Gen-Probe (NASDAQ: GPRO) announced today that Health Canada has granted the Company a medical device license for the PROGENSA(R) PCA3 assay, a new molecular urine test that helps determine the need for repeat biopsies in men suspected of having prostate cancer.
Gen-Probe acquired exclusive worldwide diagnostic rights to the PCA3 gene from DiagnoCure (CUR: TO) in November of 2003.
"Receiving a Canadian regulatory license for the PROGENSA PCA3 assay is another important milestone in our efforts to help physicians and their patients make better, more informed decisions about whether to conduct repeat prostate biopsies in men at risk of having cancer," said Carl Hull, Gen-Probe's president and chief executive officer.
In Canada, the PROGENSA PCA3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 or older who have had one or more previous negative prostate biopsies. An elevated PCA3 score is associated with an increased likelihood of a positive biopsy. A prostate biopsy is required for the diagnosis of cancer.
"Over-expression of the PCA3 gene is highly specific to cancerous prostate tissue," said Yves Fradet, MD, president, chief medical officer and co-founder of DiagnoCure and professor of surgery/urology at Universite Laval. "When evaluated alongside other risk factors, the additional insight provided by the PROGENSA PCA3 assay fills an important unmet clinical need by helping physicians conduct repeat prostate biopsies on those men who are most likely to have cancer."
Gen-Probe received Health Canada licensure for the PROGENSA PCA3 assay based on 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 submitted a Medical Device License Application to Health Canada in December of 2010.
About Prostate Cancer and PCA3
According to the Canadian Cancer Society, prostate cancer is the most common type of cancer among Canadian men (excluding non-melanoma skin cancer). In 2011, an estimated 25,500 Canadian men will be diagnosed with prostate cancer and 4,100 will die of it. One in seven Canadian men will develop prostate cancer during his lifetime, and one in 28 will die of it.
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 more than 80 peer-reviewed publications suggest that PCA3 testing, when used with other patient information, may help address some of the well-known challenges urologists face, such as identifying prostate cancers while reducing unnecessary repeat biopsies.
Gen-Probe's PROGENSA PCA3 assay is the first urine-based molecular diagnostic assay for prostate cancer. The test has been CE-marked for sale in the European Union. A regulatory application has been submitted to the US Food and Drug Administration, but the test has not been approved for marketing in the United States.
Gen-Probe 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 is headquartered in San Diego and employs approximately 1,400 people. For more information, go to http://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 approval of our PCA3 test; (ii) the risk that our PCA3 test will not be approved for marketing in the United States in the timeframe we expect, if at all; (iii) the possibility that the market for the sale of our PCA3 product in the United States or Canada 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 our financial statements and footnotes, see documents we file with the SEC, including our 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 858-410-8673For further information: Web Site: http://www.gen-probe.com