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Ticker Symbol: CUR
QUEBEC CITY, Aug. 27 /CNW Telbec/ - DiagnoCure Inc. (TSX: CUR | Quote | Chart | News | PowerRating) announced that Gen-Probe, Inc. (NASDAQ: GPRO), its partner for the development and commercialization of the PCA3 prostate cancer test, has confirmed today the beginning of a U.S. clinical study intended to secure U.S. regulatory approval of the PROGENSA(R) PCA3 assay, a new molecular test that may help determine the need for a repeat prostate biopsy.
Gen-Probe anticipates to enroll 500 men, all of whom have had a negative prostate biopsy, at 10 or more clinical trial sites. The study is expected to take less than a year, after which, Gen-Probe intends to submit a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration.
"We are excited about the announcement made today by our partner as it represents a decisive step towards maximizing the commercial value of the PCA3 test," stated John C. Schafer, President and Chief Executive Officer of DiagnoCure.
To date, more than 20 peer-reviewed publications support the clinical utility of the PROGENSA PCA3 assay in addressing the well-known limitations of the PSA (Prostate Specific Antigen) test, currently used by urologists, and therefore minimizing the unnecessary, costly and invasive biopsies that follow from "false positive" PSA results.
According to the American Cancer Society and the Canadian Cancer Society, 218,000 men in the United States and Canada will be diagnosed with prostate cancer this year, and more than 32,000 men will die from the disease. Prostate cancer is the second-leading cause of cancer death in men (after lung cancer).
About DiagnoCure
DiagnoCure (TSX: CUR | Quote | Chart | News | PowerRating) 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. 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 currently available through laboratories in the U.S. using PCA3 analyte specific reagents (ASR) from Gen-Probe, in Europe as the CE-marked PROGENSA(TM) PCA3 in vitro assay, and in Canada. 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.
%SEDAR: 00003671EF
SOURCE: DIAGNOCURE INC.
Investors: Jean-Francois Bureau, CFA, Sr. Vice President and CFO, DiagnoCure Inc., (418) 527-6100, communications@diagnocure.com; Media: Paule De Blois, Vice President, Corporate Affairs, DiagnoCure Inc., (418) 527-6100, p.deblois@diagnocure.com
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