Previstage(TM) GCC Colorectal cancer staging test featured in Expert Reviews article



    
    Ticker Symbol: CUR
    
    QUEBEC CITY, Sept. 4 /CNW Telbec/ - 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 (NASDAQ:   GPRO) 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
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.
    %SEDAR: 00003671EF




For further information:

For further information: 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, Customer Care 1(877) 701-9007, customercare@diagnocure.com

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