QUEBEC CITY, Aug. 17, 2011 /CNW Telbec/ - DiagnoCure, Inc. (TSX: CUR), a life sciences company that develops and commercializes high-value cancer diagnostic tests, today announced that Health Canada has granted Gen-Probe (NASDAQ: GPRO), the Company’s commercial partner for the PCA3 biomarker, a medical device license for the PROGENSA® PCA3 assay, a new molecular urine test that helps determine the need for repeat biopsies in men suspected of having prostate cancer.
“DiagnoCure is very proud of this Canadian approval. Thanks to a successful partnership with Gen-Probe, Canadian patients will now have access to a much more accurate test to help determine the need for a repeat prostate biopsy. This test that was first developed in Quebec City by DiagnoCure. Gen-Probe further developed a second version of the test and now ensures its commercialization,” said Dr. Yves Fradet, President, Chairman and Co-founder of DiagnoCure.
“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 years 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.
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.
The PROGENSA PCA3 assay is currently under review by the Food and Drug Administration (FDA) of the United States. On October 14, 2011, the test will be reviewed by an FDA Immunology Devices Panel, which is responsible for providing advice and recommendations to the FDA on the premarket approval application of the PROGENSA PCA3 assay.
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 biomarker 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 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.
The 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 yet been approved for marketing in the United States.
About DiagnoCure
DiagnoCure (TSX: CUR) is a life sciences company that develops and commercializes high-value cancer diagnostic tests that increase clinician and patient confidence in making critical treatment decisions. In 2008, the Company launched the PrevistageTM GCC Colorectal Cancer Staging Test through its U.S. CLIA laboratory, and granted the worldwide exclusive rights to this test to Signal Genetics in June 2011. The Company also has a strategic alliance with Gen-Probe (NASDAQ: GPRO) for the development and commercialization of a second-generation prostate cancer test using PCA3, DiagnoCure’s proprietary molecular biomarker. For more information, visit www.diagnocure.com.
Forward-looking statements
This release contains forward-looking statements that involve known and unknown risks, uncertainties and assumptions that may cause actual results to differ materially from those expected. By their very nature, forward-looking statements are based on expectations and hypotheses and also involve risks and uncertainties, known and unknown, many of which are beyond DiagnoCure’s control. As a result, investors are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements regarding the outcome of research and development projects, clinical studies and future revenues are based on management expectations. In addition, the reader is referred to the applicable general risks and uncertainties described in DiagnoCure’s most recent Annual Information Form under the heading “Risk Factors”. DiagnoCure undertakes no obligation to publicly update or revise any forward-looking statements contained herein unless required by the applicable securities laws and regulations.
