- New publication supporting the prognosis value of GCC for colon cancer
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QUEBEC CITY, May 6 /PRNewswire/ - DiagnoCure, Inc. (TSX: CUR), a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services, today reported that its PrevistageTM GCC Colorectal Cancer Staging Test will be featured at the annual meeting of the American Society of Colon and Rectal Surgeons (ASCRS) to be held in Vancouver, Canada, from May 15 to 17, 2011, with 3,000 expected attendees. In parallel to this key medical conference, the results of a recent study on the GCC test, presented earlier at ASCO GI 2011, have now been published in the peer-reviewed journal Annals of Surgical Oncology (May 2011), with Dr. Daniel J. Sargent, Professor of Biostatistics and Oncology at Mayo Clinic as lead author and Principal Investigator of the study.
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The published article reported the results of the first phase of an on-going clinical study, which was conducted on lymph nodes of 241 stage II colon cancer patients. These patients had not been treated with adjuvant chemotherapy mainly because their lymph nodes appeared cancer-free by examination under the microscope, yet 12% of them had a disease recurrence or cancer-related death afterwards. The PrevistageTM GCC test uses a technology that is 100,000 times more sensitive and which can then detect cancer cells in the lymph nodes that have escaped detection by the current microscopic examination method.
In order to establish a risk of recurrence (prognosis) for the stage II patients, the study focused on the positive lymph node (LN) ratio, defined as the number of nodes in which cancer cells were identified with the PrevistageTM GCC test, divided by the total number of nodes examined. This LN ratio approach was able to significantly predict higher recurrence risk for 84 patients (35%). In fact, the estimated recurrence rates at five years after surgery were 27% for patients with a LN ratio equal to or higher than 1/10 (high-risk group), and 10% for patients with a LN ratio under 1/10 (low-risk group).
In addition, in a subset of 181 patients with traditionally favourable prognostic factors, that is, an invasive T3 tumor and 12 or more lymph nodes examined, the PrevistageTM GCC test classified 1/3 of patients with a high risk of recurrence at five years, and 2/3 of patients at low risk of recurrence. In this subset, the high risk group had a 6 times greater likelihood to recur than the low risk group (27% vs 4%).
PrevistageTM GCC is currently the only colorectal cancer staging test on the market that provides prognostic information based on the tumor burden measured at the molecular level in the lymph nodes. Tumor burden in the lymph nodes is more and more recognized by treating physicians as a key prognostic factor to determine the risk of recurrence of cancer patients, and hence, to determine which patients might benefit most from adjuvant chemotherapy and which could be safely managed without chemotherapy.
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 PrevistageTM GCC Colorectal Cancer Staging Test, the first GCC-based molecular test for the management of colorectal cancer. To date, two major studies (JAMA 2009 and Ann Surg Onc. 2011) have demonstrated that the GCC biomarker, to which DiagnoCure owns exclusive worldwide diagnostic rights, of all the risk factors compared in the studies 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. and in Canada using PCA3 analyte specific reagents (ASR) from Gen-Probe, and in Europe as the CE-marked PROGENSA® PCA3 in vitro assay. Gen-Probe completed a 500-patient clinical study aimed at securing FDA approval for the commercialization of the PROGENSA® 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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