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Data From a New Study on Diagnocure’s GCC Assay Show Positive Results for Predicting Risk of Colon Cancer Recurrence

June 3, 2013

Previstage(TM )GCC colorectal cancer test featured at the 2013 ASCO Annual Meeting

QUEBEC CITY, June 3, 2013 /PRNewswire/ – DiagnoCure Inc. (TSX: CUR)
(OTCQX: DGCRF) today reported that results of a new study were
presented on Sunday, June 2, during the 2013 American Society of
Clinical Oncology (ASCO) Annual Meeting held in Chicago, Illinois. The
abstract of the presentation entitled “Guanylyl cyclase C (GCC)
expression in lymph nodes (LNs) as a determinant of recurrence in stage
II colon cancer (CC) patients (pts)” (Abstract #3639), by Dr. Daniel J.
Sargent, Professor of Biostatistics and Oncology at Mayo Clinic, and
colleagues, is now available on the American Society of Clinical
Oncology’s website, www.asco.org.

“We believe this new study provides very strong evidence that measuring
the expression level of GCC in lymph nodes is central to improved
staging for patients diagnosed with node-negative colon cancer.” said
Dr Yves Fradet, President and Chief Medical Officer of DiagnoCure.
“Prognostic risk stratification in stage II colon cancer remains a very
clinically important issue and the ability of our Previstage(TM) GCC test to predict recurrence independently of traditional
histopathology risk factors should have significant clinical impact for
physicians treating colon cancer and their patients.”

The VITAR retrospective study (Validating Indicators To Associate
Recurrence) had been designed to assess the relationship between GCC
gene expression in formalin fixed (FFPE) LNs and time to recurrence
(TTR) in stage II Colon Cancer patients not treated with adjuvant
chemotherapy. The second phase (called VITAR II), the results of which
were presented at the 2013 ASCO meeting, focused on the positive lymph
node ratio (LNR), defined as the number of nodes in which cancer cells
were identified with the GCC assay, divided by the total number of
nodes examined to provide recurrence risk stratification. On a
validation set including 463 untreated stage II (T3N0) colon cancer
patients from North American and European sites, the study showed that
molecular staging based on GCC LNR status was able to predict higher
recurrence risk for 195 patients (42%) treated by surgery alone. All
patients had not been treated with adjuvant chemotherapy mainly because
their lymph nodes appeared cancer-free by examination under the
microscope, yet 10% of them had a disease recurrence or died from
cancer afterwards.

Outcome associations were also strengthened when considering a 3-level
GCC categorization. In the final study cohort (n=366), the Previstage(TM) GCC test classified 21.8% of patients as having a high risk of
recurrence following surgery, 17.5% at intermediate risk and 60.7% of
patients at low risk of recurrence. In this subset analysis, the 5-year
recurrence risk was estimated at 8% and 22% for the low and high risk
groups respectively, with a hazard ratio of 2.7 (p=0.006) supporting
the prognostic capabilities of the GCC nodal status as an independent
risk factor.

These findings complement those obtained during the first phase of the
prospectively specified multi-center VITAR study performed on 241 stage
II CC patients which were published in 2011 (Sargent, Annals Surg Onc
2011).

About Colorectal Cancer and Previstage(TM) GCC

Every year in the United States and Canada, 165,000 people are diagnosed
with colorectal cancer. Of that number, 69,000 are considered at low
risk after surgery. Nonetheless, up to 20% of them suffer recurrence of
a more advanced cancer. To date, results of published studies totaling
over 1,000 patients have shown that, compared with traditionally-used
factors, the GCC biomarker is a better predictor of disease recurrence
in early stage colorectal cancer patients. Previstage(TM) GCC is currently the only colorectal cancer staging test that provides
prognostic information based on the tumor burden measured at the
molecular level in the lymph nodes. Tumor burden in the lymph nodes has
become more widely 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; OTCQX: DGCRF) is a life sciences corporation that
develops and commercializes high-value cancer diagnostic tests that
increase clinician and patient confidence in making critical treatment
decisions. In 2008, the Corporation launched a colorectal cancer
staging test through its U.S. CLIA laboratory. PrevistageTM GCC is
currently available for licensing. The Corporation has granted a
worldwide exclusive license to Gen-Probe, now a wholly-owned subsidiary
of Hologic Inc. operating as Hologic Gen-Probe, for the development and
commercialization of a prostate cancer test using PCA3, DiagnoCure’s
proprietary molecular biomarker. Hologic Gen-Probe’s PROGENSA(R) PCA3
test is commercialized in Europe under CE mark and is approved for
commercialization in Canada and the United States. For more
information, please visit www.diagnocure.com.

Forward looking statements

This release may contain forward looking statements that involve known
and unknown risks, uncertainties and assumptions that may cause actual
results to differ materially from those expected. Forward-looking
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“projects”, “should”, “will”, or the negative thereof or other
variations thereon. Forward-looking statements also include any other
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forward-looking statements are made pursuant to the “safe-harbour”
provisions of applicable Canadian securities laws. 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. Forward-looking
statements are presented for the purpose of assisting investors and
others in understanding certain key elements of the Corporation’s
current objectives, strategic priorities, expectations and plans, and
in obtaining a better understanding of the Corporation’s business and
anticipated operating environment. Readers are cautioned that such
information may not be appropriate for other purposes and that they
should not place undue reliance on these forward looking statements.
For instance, any forward-looking statements regarding the outcome of
research and development projects, clinical studies and future
revenues, including those related to PROGENSA(R) PCA3, are based on
management expectations and such outcome may vary materially depending
on global political and economic conditions, dependence on
collaboration partners, uncertainty of healthcare reimbursement, and
marketing and distribution challenges. 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.

SOURCE DiagnoCure inc.


Source: PR Newswire