- Taking Steps to Preserve Liquidity -
QUEBEC CITY, Feb. 15 /PRNewswire-FirstCall/ - DiagnoCure, Inc. (TSX: CUR), a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services, today announced changes to its enterprise structure to optimize its growth potential. Henceforth, the Company will be comprised of two business segments: (1) administrative headquarters in Quebec City, holder of the PCA3, GCC and Shc patents, and (2) DiagnoCure Oncology Laboratories (DOL), DiagnoCure's U.S. wholly-owned sales, marketing and service laboratory operations. The Company will focus its product development efforts on the pivotal clinical study, called VITAR, designed to confirm the clinical value of the Previstage(TM) GCC Colorectal Cancer Staging Test on lymph nodes. As part of the realignment of activities, John Schafer, President and CEO of DiagnoCure, will relocate to the U.S., where he will lead the commercialization activities related to Previstage(TM) GCC, and the effort to grow the DOL franchise into a profitable full service specialty laboratory featuring diagnostic tests for colorectal cancer. Dr. Yves Fradet, currently Chairman of the Board, will also become President of DiagnoCure, Inc. effective today.
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This realignment, coupled with a selective reduction in personnel that maintains all of the Company's core competencies, is expected to allow DiagnoCure to preserve all the liquidity necessary to support its operations until the sales of Previstage(TM) GCC ramp up and the PCA3 test is approved for sale in the U.S. This approval is now anticipated to occur in 2011, following the expected 2010 submission of a premarket approval application (PMA) by DiagnoCure's partner, Gen-Probe, to the U.S. Food and Drug Administration (FDA).
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"The need for specialty service cancer laboratories in the United States is growing, and with new molecular diagnostic tests, the ability to fill that need is available. I believe that DiagnoCure can make a real difference with its Previstage(TM) GCC test, and the addition of profitable laboratory tests focused on helping physicians and patients make the best treatment decisions, is a winning formula for success." said John Schafer.
Dr. Yves Fradet added: "DiagnoCure has been in business for over fifteen years now. We have proven that we can identify powerful and significant markers for cancer diagnosis, develop clinically relevant and reliable tests, and take the best route to commercialization. With the optimization that we are implementing today, we will focus even more on what we know and do best, and be in a better position to benefit from the expected growth of PCA3 and GCC test sales."
About the VITAR clinical study for the Previstage(TM) GCC test
In late 2009, DiagnoCure initiated a new multicenter retrospective pivotal clinical study, called VITAR (Validating Indicators To Associate Recurrence Risk) to confirm the clinical utility of the Previstage(TM) GCC Colorectal Cancer Staging Test in lymph nodes. The study is expected to include 700 to 1,000 patients, and aims to demonstrate that Previstage(TM) GCC can more accurately predict the risk of recurrence in patients considered low risk by traditional histological assessment methods (pN0 patients). Already, close to 300 patients have been enrolled in the study. The Company targets the completion of the full study by the fall of 2010.
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. 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. using PCA3 analyte specific reagents (ASR) from Gen-Probe, in Europe as the CE-marked PROGENSA(R) 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.
SOURCE DiagnoCure Inc.
