CHICAGO, IL, May 29 /PRNewswire-FirstCall/ - DiagnoCure Oncology Laboratories based in West Chester, PA, will exhibit at the American Society of Clinical Oncology Annual Meeting (ASCO) on May 30th-June 3rd in Chicago, Illinois. The Company’s newly established sales force will be on hand to introduce Previstage(TM) GCC, the first molecular diagnostic test for the staging of colorectal cancer and educate clinicians on the science of guanylyl cyclase C (GCC).
The histopathological status of the lymph node is the most important prognostic criterion for recurrence of colon cancer. However, despite best efforts, histopathology can miss metastases, resulting in recurrence in up to 25 - 30 percent of node negative patients. Extensive research conducted by Dr. Scott Waldman at Thomas Jefferson determined when the expression of GCC mRNA is detected outside of the intestine (such as in the lymph nodes), it is a highly sensitive, early indication that colorectal cancer has spread.
The Previstage GCC test employs qRT-PCR technology, which has been shown to be up to 100,000-times more sensitive than traditional histopathology in detecting occult metastases. The technology can detect one cancer cell in up to 10 million cells, versus one in 200 normal cells with traditional methods. The Previstage GCC test should provide clinicians a significantly more sensitive tool than traditional histopathology review alone for staging a patient with colorectal cancer and therefore may help the physician determine the most appropriate course of treatment. With the Previstage GCC test, a positive result would be an indication of lymph node metastases and would be consistent with a patient having Stage III disease.
“We now understand that having occult metastases is critical to the accurate staging of colorectal cancer. It is not feasible to test an entire node via traditional methods when an average 0.5 cm lymph node could yield up to 1000 sections,” stated John Schafer, CEO of DiagnoCure Oncology Laboratories. “Therefore, we are excited to introduce Previstage GCC, an advanced, highly specific molecular staging method which could provide clinicians with the ability to detect with molecular techniques clinically relevant cancer, which may have been missed by traditional techniques.”
DiagnoCure Oncology Laboratories will be the only facility to offer the Previstage GCC Colorectal Cancer Staging Test and the Company has recently hired a specialty sales force dedicated to educating clinical oncologists and other members of the colorectal cancer management team in the capabilities of the new test. The Company’s target is for its Pennsylvania-based laboratory to be CLIA certified and begin exclusively offering this high-value diagnostic test for the staging of colorectal cancer in the second half of 2008.
About Previstage(TM) GCC
Staging a patient with colorectal cancer is crucial because it determines the patient’s course of treatment. Current standard of care requires that pathologists examine microscopically a thin slice of tissue from each of 12 or more lymph nodes harvested during the patient’s surgery to see if cancer has spread beyond the intestine. Currently up to 25 - 30 percent of patients with no pathologically-positive lymph nodes (stage I and II cancers) later return with recurrent disease, presumably through occult metastases that have escaped detection. Most of these patients do not receive additional therapies such as chemotherapy. Previstage GCC aims to provide clinicians a significantly more sensitive tool for staging a patient with colorectal cancer.
Strong early data supported the potential importance of the GCC test in improving the staging of colorectal patients. This resulted in the National Cancer Institute sponsoring a prospective clinical trial of GCC testing in colorectal cancer patients conducted over five years. This study has been completed and the Company’s collaborators at Thomas Jefferson University will be presenting the results of the study at major medical conferences later this year.
About DiagnoCure Oncology Laboratories
DiagnoCure Oncology Laboratories based in West Chester, PA is a subsidiary of DiagnoCure Inc. , 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. For more information visit www.diagnocurelabs.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.
CONTACT: Contact: DiagnoCure Oncology Laboratories: Blair Shamel, Senior
Vice President, Corporate Development, (858) 673-1907; Paule De Blois, Vice
President, Corporate Affairs, (418) 527-6100,
communications@diagnocure.com; Media Contact: Troy Pearson, Mentus Life
Science, (858) 455-5500 X320, Troy@mentus.com