QUEBEC CITY, May 20 /CNW Telbec/ - DiagnoCure Inc. (TSX: CUR - News), a life sciences company commercializing high-value cancer diagnostic tests and delivering lab services, reports key milestones related to the market introduction of its Previstage(TM) GCC colorectal cancer staging test, and the expanded utility of its PCA3 marker for the detection of prostate cancer. In preparation for the impending introduction of Previstage(TM) GCC, the Company has started to hire seasoned sales professionals in the United States, and its reimbursement strategy is being deployed with Premier Source, a leading provider of reimbursement services for pharmaceutical and diagnostic companies.
“This is an exciting time for DiagnoCure and the health sector in general, as more and more healthcare practitioners recognize the high value of molecular diagnostic tests, such as our GCC test and PCA3 marker, in providing more accurate information to physicians and their patients to support critical clinical decisions”, stated John Schafer, President and CEO of DiagnoCure. “PCA3 is already available in Europe and North America, and is receiving positive press. Previstage(TM) GCC, which will soon be available in North America from our clinical laboratories in West Chester, PA, will be the first molecular test for the staging of colorectal cancer. Over 50 studies have reported the biology and potential clinical utility of the GCC marker in the management of colorectal cancer. A prospective, 5-year NIH-sponsored study conducted by Dr. Scott Waldman from the Thomas Jefferson University on the detection of GCC in lymph nodes was recently completed, with results to be reported later this year.”
Previstage(TM) GCC to be launched this summer
DiagnoCure is proud to report that it has finalized the development of its research GCC test for the staging of colorectal cancer. The final development and validation of its commercial Previstage(TM) GCC test are now being completed by its clinical laboratories in West Chester, PA. The Company expects to meet the necessary CLIA licensing requirements in time to launch Previstage(TM) GCC this summer.
This test is intended to more accurately establish the stage of the colorectal cancer, by the identification of occult metastases in the patient’s lymph nodes associated with the tumor. Physicians base their decisions about further treatment, such as chemotherapy, largely on presence of cancer cells in the regional lymph nodes, and the current method using microscopic examination of the tissue understages 30% or more of patients.
In preparation of the upcoming launch of the test, DiagnoCure will be discussing the need for more accurate staging of colorectal cancer lymph nodes and the science behind Previstage(TM) GCC at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago at the end of May. This meeting is host to over 30,000 health practitioners concerned with cancer and represents an important opportunity for DiagnoCure to educate the medical community about the potential of Previstage(TM) GCC.
ASCO will feature several interesting studies about colorectal cancer, including one from Dr. Scott Waldman on his discovery of and studies on the GCC marker. More information can be found on the ASCO web site.
PCA3 study demonstrates exciting new utility in the management of prostate cancer
An important article published in the May issue of the peer-reviewed Journal of Urology (Vol. 179, 1804-1810) provided additional insights on the potential of PCA3 in the management of prostate cancer. Whereas previous studies have shown the marker to be very useful in predicting the outcome of prostate biopsies, this new study on 96-men conducted by the University of Texas M.D. Anderson Cancer Center and Gen-Probe established that PCA3 scores correlate with both tumor volumes and prostatectomy Gleason scores, both of which are measures of prostate cancer aggressiveness. As a result, the researchers concluded that PCA3 may have clinical applicability in identifying men who have low-volume or low-grade prostate cancer and who could be followed with active surveillance instead of requiring immediate treatment.
This article received significant press coverage of high visibility in the United States and Europe. This new study could further increase both the utility and market potential of PCA3.
About DiagnoCure
DiagnoCure (TSX: CUR - News) 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 is currently preparing to launch the Previstage(TM) GCC Colorectal Cancer Staging Test, the first GCC-based molecular test for the management of colorectal cancer. In 2003, the Company entered into a strategic alliance with Gen-Probe (NASDAQ: GPRO - News) for the development and commercialization of a second generation test for PCA3, DiagnoCure’s proprietary molecular marker highly specific to prostate cancer. The test is now 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. In addition to its own research, the Company intends to acquire or in-license additional promising cancer biomarkers from both academic and commercial institutions. 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.
For further information
Investors: DiagnoCure Inc., J.F. Bureau, CFA, Sr. Vice President and CFO, (418) 527-6100, communications@diagnocure.com Media: Jean-Pierre Trudel & Associates, Jean-Pierre Trudel, (514) 347-6111, jp.trudel@videotron.ca
Source: DIAGNOCURE INC.