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Last updated on April 16, 2014 at 12:17 EDT

PCA3 Test Featured at American Urological Association Meeting

May 25, 2012

DiagnoCure Management Responds to USPSTF Recommendation on Prostate
Cancer Screening

Ticker Symbol: CUR

QUEBEC CITY, May 25, 2012 /PRNewswire/ – DiagnoCure Inc. (TSX: CUR), a
Quebec life sciences company that develops and commercializes
high-value cancer diagnostic tests, reported that the PROGENSA PCA3
prostate cancer diagnostic test has been featured in a number of
presentations and discussions at the American Urological Association
(AUA) meeting in Atlanta, GA. The value of PCA3 testing was highlighted
during a debate on the new USPSFT recommendation on prostate cancer
screening. PCA3 testing was the topic of 14 presentations during the
meeting.

USPSTF Recommendation on Prostate Cancer Screening – Implications for
PROGENSA PCA3 Test

On Monday May 21, the US Preventive Services Task Force (USPSTF) issued
its final recommendation against the routine use of prostate-specific
antigen (PSA)-based screening for prostate cancer. The Task Force has
stated that PSA testing results in little or no reduction in prostate
cancer-specific mortality and is associated with harms related to
subsequent evaluation and treatments, some of which may be unnecessary.
The recommendation applies to asymptomatic men in the general U.S.
population, regardless of age, but does not include the use of the PSA
test for surveillance after diagnosis or treatment of prostate cancer.
The recommendation has been publicly criticized by the American
Urological Association. The issue was debated by leading urologists
during a “Town Hall” meeting at the AUA meeting earlier this week.

DiagnoCure management believes that the USPSTF recommendation may have
positive implications for the use of the PROGENSA PCA3 test. The PCA3
urine test provides an opportunity to reduce the harm of PSA screening
by reducing the number of unnecessary biopsies while identifying the
lethal cancers. This argument in favor of PROGENSA PCA3 testing was
made during a presentation at the AUA meeting by Dr. John Wei,
professor at the University of Michigan.

Dr. Yves Fradet, President and Chief Medical Officer of DiagnoCure
commented, “These opposing views of the USPSTF and the AUA, as well as
the ongoing debate in clinical community on the most effective way to
screen for prostate cancer, highlight the great need for a test like
PCA3 to reduce the burden of PSA screening while maintaining the
progress made in fighting this number one cancer in men.”

Clinical Data on PROGENSA PCA3

On Wednesday May 23, Dr. Wei presented results of a PROGENSA PCA3 trial
conducted by the NCI Early Detection Research Network (NCI-EDRN). This
was a multicenter study from 11 clinical US centers, with the objective
of completing a comprehensive and independent validation of the
PROGENSA PCA3 Assay for the detection of prostate cancer both in the
repeat and first biopsy setting. A total of 880 eligible men were
enrolled, including 305 who had a prior negative prostate biopsy. Men
with a PCA3 score >60 had 80% probability of a positive biopsy while
those with a PCA3 score <20 had 88% probability of having a negative
biopsy. The results validated the initial hypothesis of the authors.
PCA3 performance was superior to all other diagnostic tools tested in
the study for the detection of any cancer and high grade cancers. The
authors believe those results, which are significant improvements over
classical diagnostic tools, will allow PCA3 to greatly enhance clinical
decision making.

The PROGENSA PCA3 assay was approved by the FDA on February 15 and is
the first urine based molecular test to help determine the need for
repeat prostate biopsies in men who have had a previous negative
biopsy. The test is marketed by Gen-Probe, DiagnoCure’s commercial
partner.

About Prostate Cancer and the PROGENSA PCA3 Assay

According to the American Cancer Society (ACS), prostate cancer is the
second most common type of cancer found in American men (behind skin
cancer), and the second leading cause of cancer death in men (after
lung cancer). One in six American men will get prostate cancer during
his lifetime, and one in 36 will die from it. The ACS estimates that
about 241,000 Americans were newly diagnosed with prostate cancer in
2011, and that approximately 34,000 men died from the disease.

PCA3 is a gene that is highly over expressed in prostate cancers.
Following a digital rectal examination, the PCA3 gene can be quantified
in urine specimens together with the prostate specific antigen (PSA)
gene to generate a PCA3 score. Studies have shown that because the PCA3
gene is highly specific for prostate cancer, it predicts the results of
repeat biopsies more accurately than traditional serum PSA testing in
patients who have had one or more previous negative prostate biopsies.

Data from more than 80 peer reviewed publications suggest that PCA3 gene
testing, when used with other patient information, may help address
some of the well known challenges urologists face, such as identifying
prostate cancers while reducing unnecessary repeat biopsies.
Gen Probe’s PROGENSA PCA3 assay is the first urine based molecular
diagnostic assay to aid in the decision for repeat biopsy. The test has
received regulatory approval and is available for sale in the United
States, Canada and the European Union.

DiagnoCure granted Gen Probe exclusive worldwide diagnostic rights to
the PCA3 gene in November 2003. Under the terms of the agreement,
DiagnoCure will initially receive 8% royalties on sales, increasing to
16% after $62.5 million cumulative sales, of which about half has been
reached to date.

About DiagnoCure

DiagnoCure (TSX: CUR) is a life sciences company that develops and
commercializes high-value cancer diagnostic tests that increase
clinician and patient confidence in making critical treatment
decisions. In 2008, the Company launched the Previstage(TM )GCC Colorectal Cancer Staging Test through its U.S. CLIA laboratory, and
granted the worldwide exclusive rights to this test to Signal Genetics
in June 2011. 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 biomarker. The PROGENSA(R) PCA3 test is
commercialized in Europe under CE mark and is now approved for
commercialization in Canada and the United States. 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 unless required by the
applicable securities laws and regulations.

SOURCE DIAGNOCURE INC.


Source: PR Newswire