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Last updated on April 18, 2014 at 21:21 EDT

Previstage(TM) GCC Colorectal Cancer Staging Test Featured in Expert Reviews Article

September 4, 2008

QUEBEC CITY, Sept. 4 /PRNewswire-FirstCall/ — The Previstage(TM) GCC Colorectal Cancer Staging Test, recently launched by DiagnoCure Oncology Laboratories, a wholly owned subsidiary of DiagnoCure Inc., is featured in this month’s issue of Expert Reviews in Molecular Diagnostics. The article, which was written by Dr. Scott A. Waldman and Dr. Alex Mejia, from Thomas Jefferson University, reports that Previstage(TM) GCC detects occult metastases in lymph nodes, identifying patients who may be at increased risk of developing recurrent disease and who could most benefit from adjuvant chemotherapy.

The article discussed the limitations of the traditional microscopic method for the staging of colorectal cancer patients, and the benefit of molecular techniques, such as the GCC marker and the Previstage(TM) GCC Colorectal Cancer Staging Test. In particular, the article reported that eleven published studies suggested that other markers, such as CEA and CK, were not useful for colorectal cancer patient management. In comparison, recent studies demonstrated that guanylyl cyclase C (GCC) was a specific marker for metastatic colorectal cancer. An initial GCC assay showed an analytical sensitivity of 93% and specificity of 97% in a study in which it identified occult metastases in 6 patients out of 23 (26%), who were considered metastasis-free (stage I and II) by the present microscopic staging method. A more recent prospective, multicenter clinical trial of the GCC assay, which involved 2500 lymph nodes from approximately 250 stage I and II patients, concluded that when the GCC assay was negative, patients had a three to four-fold lower disease recurrence rate. On the other hand, when the GCC assay was positive, patients had a recurrence rate similar to stage III patients. In addition, GCC was the single most important independent prognostic marker for recurrence of stage I and II patients.

“Guanylyl Cyclase C is the most sensitive and specific marker described to date for identifying metastatic colorectal cancer cells in extra-intestinal tissues,” commented Dr. Waldman. “GCC could help identify patients with low risk of disease recurrence and those who might benefit from adjuvant chemotherapy.”

Following on the work of Dr. Waldman, DiagnoCure developed the Previstage(TM) GCC Colorectal Cancer Staging Test at its U.S. CLIA-approved clinical laboratory. The GCC test was optimized to improve the processing of lymph node specimens and the test has shown very high analytical accuracy in detecting GCC levels consistent with the presence of occult metastases in the lymph nodes.

“Dr. Waldman’s studies support the value of Previstage(TM) GCC, developed by DiagnoCure. We believe the test represents a leap forward for the staging of colorectal cancer patients and will help guide clinicians and physicians in making critical treatment decisions,” stated John C. Schafer, President and CEO of DiagnoCure Inc.

About Previstage(TM) GCC

Every year in North America, 174,000 people are diagnosed with colorectal cancer, and 142,000 colorectal cancer surgeries are performed. Staging a patient with colorectal cancer is crucial because it determines the patient’s course of treatment after the surgery. Current standard of care requires that pathologists microscopically examine a thin slice of tissue from each of the lymph nodes harvested during the patient’s surgery to see if cancer has spread. Currently, up to 25 – 30 percent of patients with no pathologically-positive lymph nodes (stage I and II cancers) later develop recurrent disease, presumably through occult metastases that have escaped detection. Most of these patients do not receive additional therapies such as chemotherapy. With a detection capacity that is close to 100,000 more sensitive than microscopic methods, Previstage(TM) GCC provides clinicians with significantly more accurate information for staging a patient with colorectal cancer that will increase their confidence in making critical treatment decisions.

Clinical study data supports the potential for the GCC test to improve the current staging of colorectal patients. The National Cancer Institute sponsored a five-year prospective clinical trial of GCC testing in colorectal cancer patients. This study has been recently completed and the Company’s collaborators at Thomas Jefferson University are presenting the results at major medical conferences throughout the year.

The Previstage(TM) GCC Colorectal Cancer Staging Test is a laboratory-developed test and its performance characteristics have been determined by DiagnoCure Oncology Laboratories.

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., recently 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. 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 http://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.

DIAGNOCURE INC.

CONTACT: Investors: J.F. Bureau, CFA Sr. Vice President and CFO,DiagnoCure Inc., (418) 527-6100, communications@diagnocure.com; Media: U.S.:Troy Pearson, Mentus Life Science, (858) 455-5500 X320, Troy@mentus.com;Canada: Jean-Pierre Trudel, Jean-Pierre Trudel & Associates, (514) 347-6111,jp.trudel@videotron.ca; Clinicians: DiagnoCure Oncology Laboratories, CustomerCare 1(877) 701-9007, customercare@diagnocure.com