QUEBEC CITY, QC and WEST CHESTER, PA, Feb. 17 /PRNewswire-FirstCall/ - The Journal of the American Medical Association (JAMA), Vol. 301, #7, this week published positive results from a major prospective 5-year multicenter study of over 400 enrolled patients demonstrating that guanylyl cyclase C (GCC) is the strongest independent predictor of colorectal cancer recurrence in patients considered low risk by current assessment methods. The study was conducted by investigators from Thomas Jefferson University, with contributions from McGill University, the Fox Chase Cancer Center and others. DiagnoCure Inc. owns the exclusive worldwide diagnostic rights to the GCC biomarker, and since last September has offered the Previstage(TM) GCC test to physicians and patients from its Pennsylvania-based service laboratory.
GCC is a gene coding for a protein which is expressed in colorectal cells, both normal and cancerous, but is never found in normal tissue in other parts of the body. When GCC is detected in lymph nodes removed during colorectal cancer surgery, it is an indication of the presence of colorectal cancer metastases.
The study’s principal investigator, Dr. Scott Waldman, Chairman of the Department of Pharmacology and Experimental Therapeutics at Thomas Jefferson University, stated “Patients with cancer cells in their regional lymph nodes carry a worse prognosis and a higher risk of recurrence; detecting GCC in the patient lymph nodes could be useful for identifying patients who might benefit from treatment with adjuvant chemotherapy.”
In a group of 257 colorectal cancer (CRC) patients who were thought to have a lower risk of recurrence according to histopathology (stage I and II patients), when GCC was considered independently from other factors, patients whose nodes were GCC positive were 4.7 times more likely to develop disease recurrence than those whose nodes were GCC negative, and 3.3 times more likely to die within three years. In fact, patients with GCC positive nodes had a risk of recurrence and survival rate comparable to that of patients considered higher risk by histopathology (stage III).
Currently, most patients who are considered to have a lower risk of recurrence by histopathology do not receive adjuvant treatment, such as chemotherapy, after their surgery. However, it is widely recognized that histopathology, which consists of microscopically examining thin slices of the lymph nodes, is imperfect and up to 30% of histopathology node-negative patients experience disease recurrence and face greater risk of death. Guanylyl cyclase C is the first validated marker useful in detecting the presence or absence of CRC cells in the regional lymph nodes, using a technology that is 100,000 times more sensitive than the current microscopic method. With GCC testing, patients who are most likely to experience CRC recurrence can receive appropriate treatment, while those who are at lower risk of disease recurrence can avoid the negative side effects of treatment.
“The results from this study, published in the peer-reviewed Journal of the American Medical Association, provide strong evidence that GCC matters when it comes to predicting the risk of colorectal cancer recurrence and is a major advance for the individualized treatment of colorectal cancer patients. With our very sensitive GCC-based test, physicians and their patients now have an opportunity to use the latest genomic technology to help them make the best possible treatment decisions,” said John Schafer, President and CEO of DiagnoCure.
Every year in North America, 174,000 people are diagnosed with colorectal cancer and 61,000 die from it.
About Previstage(TM) GCC Colorectal Cancer Staging Test
Previstage(TM) GCC Colorectal Cancer Staging Test is the first test that can molecularly assess the presence or absence of CRC cells in the lymph nodes removed during the surgery. The test is a laboratory-developed proprietary assay that detects in lymph nodes the expression or absence of expression of the GCC marker. When GCC is expressed in the lymph nodes, it is an indication of the presence of colorectal cancer metastases, and hence an indication of higher risk of disease recurrence. Knowing the lymph nodes status can help physicians and patients make optimal treatment decisions. The test was launched in 2008 and is exclusively performed by DiagnoCure Oncology Laboratories, a CLIA-certified service laboratory, located in West Chester, Pennsylvania.
About DiagnoCure
DiagnoCure 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. In 2008, DiagnoCure Oncology Laboratories, a subsidiary of DiagnoCure Inc., launched the Previstage(TM) GCC Colorectal Cancer Staging Test, the first GCC-based molecular test for the management of colorectal cancer. The Company also has a strategic alliance with Gen-Probe for the development and commercialization of a second-generation prostate cancer test using PCA3, DiagnoCure’s proprietary molecular marker. This test is also 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.
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