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DIAGNOCURE';S PCA3 PROSTATE CANCER BIOMARKER SUBMITTED BY GEN-PROBE TO THE U.S. FOOD AND DRUG ADMINISTRATION

^{Published on 2010-09-21 13:10:24 - Market Wire}
 

QUEBEC CITY, Sept. 21 /CNW Telbec/ - DiagnoCure, Inc. (TSX: CUR), a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services, announced today that its commercial partner, Gen-Probe Incorporated, has filed a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA) for its PROGENSA(R) PCA3 assay, a new molecular test that may help determine the need for repeat biopsies in men suspected of having prostate cancer. DiagnoCure holds the worldwide rights to the PCA3 biomarker and, in 2003, granted an exclusive sub-license to Gen-Probe for diagnostic applications.

"DiagnoCure and its shareholders have been waiting for this important announcement that represents a key milestone towards the commercialization of the PCA3 biomarker in the United States. Indeed, if and when the PROGENSA(R) PCA3 assay is approved by the FDA, Gen-Probe will be able to launch it in the U.S. with a sales and marketing program that could translate into a notable ramp-up of PCA3 sales," stated Dr. Yves Fradet, President and Chief Medical Officer of DiagnoCure.

Gen-Probe is seeking FDA approval to use the PROGENSA(R) 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. In its second quarter earnings call, Gen-Probe indicated that the results of this study are consistent with those of many other studies conducted to date, and stated that it intends to present the data at a future medical meeting.

The FDA has formally accepted Gen-Probe's PMA filing, and has advised Gen-Probe 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) and the Canadian Cancer Society (CCS), prostate cancer is the second most common type of cancer found in North American men (behind skin cancer), and the second-leading cause of cancer death in men (after lung cancer). One in six North American men will get prostate cancer during his lifetime, and one in 36 will die from it. The ACS and CCS estimate that about 242,000 North Americans will be newly diagnosed with prostate cancer in 2010, and that approximately 36,000 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. Moreover, a recent European study suggested that PCA3 testing also could predict the outcome of initial biopsies in men suspected of having prostate cancer.

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 in Canada using PCA3 analyte specific reagents (ASR) from Gen-Probe, and in Europe as the CE-marked PROGENSA(R) PCA3 in vitro assay. Gen-Probe completed a 500-patient clinical study aimed at securing FDA approval for the commercialization of the PROGENSA(R) PCA3 test in the U.S. and filed a PMA in September 2010. 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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