DiagnoCure's PCA3 test at the forefront of the management of prostate cancer
- New study showing good performance before the initial prostate biopsy
QUEBEC CITY, April 22 /CNW Telbec/ - DiagnoCure, Inc. (TSX: CUR), a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services, announced that its proprietary prostate cancer biomarker PCA3 was the topic of over 13 presentations at the 2010 European Association of Urology (EAU) meeting, the world largest urology event, held in Barcelona, Spain, with 14,000 registrants. PCA3 was discussed by prominent researchers who presented reviews and data on the clinical value of the test in the management of prostate cancer, including a new multi-center study which suggested that PCA3 could be useful for predicting the outcome of an initial prostate biopsy, thereby reducing prostate biopsies by 40%, while missing only 5% of the high grade cancers on the initial biopsy.
This new European study of 516 men, which was presented at the meeting, demonstrated that PCA3 could improve the prediction of the outcome of initial prostate biopsies while being indicative of cancer aggressiveness. In the study, patients with a PCA3 score over 35 were almost 3 times more likely to have a positive initial prostate biopsy than patients with a score under 35. The principal investigator, Pr. Alexandre de la Taille from the urology service of Henri Mondor hospital, Creteil, France, explained: "When the results of this study are combined with the results of another study we did on patients with a first negative biopsy, the PCA3 test proved to have a high predictive value as prostate cancer could be detected, at the initial or subsequent biopsy, in about 75% of men with a PCA3 score over 35. Moreover, our new study showed that with a cut-off of 20, 40% of patients could have avoided undergoing a prostate biopsy, while only 5% of the high grade cancers (all grade 7) would have been missed on the initial biopsy."
In addition, during a plenary session of the EAU, Jack A. Schalken, Professor of experimental urology at the Radboud University Nijmegen Medical Center, The Nederlands, reviewed the prostate cancer molecular markers currently being researched, and concluded that PCA3 was by far the most advanced and most promising to answer the currently unmet clinical needs in the management of prostate cancer.
"We are very pleased to see PCA3 advancing at the forefront of the management of prostate cancer. With the growing number of conclusive studies, more and more physicians, patients and governments are convinced of the clinical value the marker. Some pharmaceutical companies are also considering the PCA3 test in their clinical drug trials," stated Dr. Yves Fradet, President and Chief Medical Officer of DiagnoCure, who attended the EAU meeting.
About DiagnoCure
DiagnoCure (TSX: CUR) is a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services that increase clinician and patient confidence in making critical treatment decisions. DiagnoCure Oncology Laboratories, a subsidiary of DiagnoCure Inc., launched in 2008 the Previstage(TM) GCC Colorectal Cancer Staging Test, the first GCC-based molecular test for the management of colorectal cancer. A major study published in the February 18, 2009, edition of the Journal of the American Medical Association demonstrated that GCC, to which DiagnoCure owns exclusive worldwide diagnostic rights, is the strongest independent predictor of colorectal cancer recurrence. More clinical studies are underway to confirm the clinical utility of the Previstage(TM) GCC test. The Company 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 marker. This test is available through laboratories in the U.S. and Canada using PCA3 analyte specific reagents (ASR) from Gen-Probe, and in Europe as the CE-marked PROGENSA(R) PCA3 assay. A clinical study aimed at securing FDA approval for the commercialization of PROGENSA(R) PCA3 test in the U.S. is underway. 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.
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For further information: For further information: Investors: Frédéric Boivin, Sr. Director, Finance and Administration, DiagnoCure Inc., (418) 527-6100, [email protected]; Media: Paule De Blois, Sr. Vice President, Operations, DiagnoCure Inc., (418) 527-6100
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