Promising Data on Molecular Research Test for Prostate Cancer Published in Peer-Reviewed Journal UROLOGY(R)



    In Study, Urine-Based Research Assay for Highly Specific Prostate Cancer
    Gene PCA3 Predicts Repeat Biopsy Result More Accurately than Traditional
    Method

    SAN DIEGO and QUEBEC CITY, March 29 /CNW Telbec/ - Gen-Probe's
(NASDAQ:   GPRO) research test for the highly specific prostate cancer gene PCA3
in urine predicted the results of repeat biopsies more accurately than
traditional prostate specific antigen (PSA) testing, according to a study of
233 men published in the March issue of the peer-reviewed journal UROLOGY(R)
(69: 532-535, 2007).
    "Men with elevated serum prostate-specific antigen (PSA) levels and
negative prostate biopsy findings present a dilemma because of the lack of an
accurate diagnostic test," said lead author Leonard S. Marks, MD, clinical
associate professor of urology at UCLA and medical director of the Urological
Sciences Research Foundation. "The results from this research study indicate
that the PCA3 assay may be a new tool to assist clinicians in the treatment of
these 'PSA dilemma' patients."
    The study included men with serum PSA levels of at least 2.5 ng/mL from
three North American hospitals. All the men previously had a negative biopsy,
and were scheduled for a follow-up biopsy. The median age of the men was 64,
and their median serum PSA level was 6.1 ng/mL. In the study, the researchers
collected urine from the men after a digital rectal examination. Approximately
97% of the samples were "informative," meaning they contained adequate genetic
material for analysis. Repeat prostate biopsies revealed prostate cancer in
about 27% of these men.
    The researchers found that the risk of a positive repeat biopsy
correlated with the PCA3 score. For example, among the 26 men in the study who
had a PCA3 score of less than 5, only 12% had a positive repeat biopsy. In
contrast, among the 18 men with a PCA3 score greater than 100, 50% had a
positive repeat biopsy. For all the men in the study, the PCA3 research assay
yielded an odds ratio of 3.6, meaning that men with an elevated PCA3 score
were 3.6 times more likely to have a positive repeat biopsy than men with a
normal PCA3 score.
    In addition, the researchers used a statistical method called receiver
operating characteristic (ROC) curve analysis to assess the ability of the
PCA3 research assay to predict the result of the follow-up prostate biopsy.
For the PCA3 score, the area under the ROC curve was 0.68. In comparison, the
serum PSA assay yielded an area under the curve of 0.52, "indicating little
better than a 'coin toss' probability of predicting the presence of prostate
cancer," according to the authors. In the study, the PCA3 assay had a
sensitivity of 58%, and a specificity of 72%.
    "About 1 million US men undergo a prostate biopsy annually to detect
prostate cancer in only one-fourth of them," Dr. Marks said. "Furthermore, men
with negative biopsy findings but elevated PSA levels still have the
possibility of having prostate cancer. Many will undergo additional biopsies.
The dollar cost, risk of morbidity, and emotional turmoil of repeat prostate
biopsies are considerable, and a more accurate prostate cancer test would be
an important clinical advance for this vexing problem. In this research study,
the urinary PCA3 score was superior to serum PSA for predicting the outcome of
repeat biopsies. The high specificity and informative rate suggest that the
PCA3 research assay could have an important role in prostate cancer
diagnosis."
    Gen-Probe's PCA3 research test detects the overexpression of PCA3 mRNA in
urine. Previous studies have shown that PCA3 is overexpressed, relative to
benign cells, by 60- to 100-fold in more than 90% of prostate tumors,
indicating that the gene may be a useful biomarker for prostate cancer. In
contrast, serum PSA may be elevated due to a number of benign conditions,
resulting in "false positive" results and unnecessary biopsies. In fact, as
many as three-quarters of men suspected to have cancer based on serum PSA
testing actually have non-cancerous conditions such as benign prostatic
hyperplasia (BPH).
    Gen-Probe's PROGENSA(TM) PCA3 assay is CE-marked, allowing it to be
marketed in the European Union. The research assay is not approved for
marketing in the United States.
    The PCA3 gene was discovered by Dr. Marion Bussemakers while working with
Dr. Jack Schalken at the University of Nijmegen in the Netherlands and in the
laboratory of Dr. William Isaacs at Johns Hopkins University in Baltimore,
Maryland. DiagnoCure Inc. (TSX: CUR) is the exclusive worldwide licensee for
all diagnostic and therapeutic applications of the gene. Gen-Probe acquired
exclusive worldwide diagnostic rights to the PCA3 gene from DiagnoCure in
November of 2003.

    About Gen-Probe

    Gen-Probe Incorporated is a global leader in the development, manufacture
and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs)
that are used primarily to diagnose human diseases and screen donated human
blood. Gen-Probe has more than 24 years of NAT expertise, and received the
2004 National Medal of Technology, America's highest honor for technological
innovation, for developing NAT assays for blood screening. Gen-Probe is
headquartered in San Diego and employs approximately 1,000 people. For more
information, go to www.gen-probe.com.

    About DiagnoCure

    DiagnoCure specializes in the development, production and
commercialization of molecular diagnostics for the detection and management of
cancer. Its first test, ImmunoCyt(TM) / uCyt+(TM) for bladder cancer, is
distributed worldwide. In 2003, the Company entered into a strategic alliance
with Gen-Probe (NASDAQ:   GPRO) for the development and commercialization of a
second generation PCA3-based diagnostic test for prostate cancer. The Company
plans to expand its product portfolio, namely in prostate, lung and other
cancers. In addition to its own research, the Company intends to acquire or
in-license promising cancer biomarkers from both academic and commercial
institutions. Additional information can be found at www.diagnocure.com.

    Caution Regarding Forward-Looking Statements

    Any statements in this press release about Gen-Probe's or DiagnoCure's
expectations, beliefs, plans, objectives, assumptions or future events or
performance are not historical facts and are forward-looking statements. These
statements are often, but not always, made through the use of words or phrases
such as believe, will, expect, anticipate, estimate, intend, plan and would.
For example, statements concerning new products, potential regulatory
approvals, customer adoption, and results of future R&D studies are all
forward-looking statements. Forward-looking statements are not guarantees of
performance. They involve known and unknown risks, uncertainties and
assumptions that may cause actual results, levels of activity, performance or
achievements to differ materially from those expressed or implied by any
forward-looking statement. Some of the risks, uncertainties and assumptions
that could cause actual results to differ materially from estimates or
projections contained in the forward-looking statements include but are not
limited to: (i) the risk that subsequent studies of our PCA3 assay may not
reflect the results discussed here, (ii) the risk that new products, such as
our PCA3 assay, will not be cleared for marketing in other markets in the
timeframes we expect, if at all, (iii) the possibility that the market for the
sale of our new products, such as our PCA3 test, may not develop as expected,
(iv) we may not be able to compete effectively, (v) we may not be able to
maintain our current corporate collaborations and enter into new corporate
collaborations or customer contracts, and (vi) we are dependent on third
parties for the distribution of some of our products. The foregoing describes
some, but not all, of the factors that could affect our ability to achieve
results described in any forward-looking statements. For additional
information about risks and uncertainties Gen-Probe faces and a discussion of
the Company's financial statements and footnotes, see documents filed with the
SEC, including the most recent annual report on Form 10-K and all subsequent
periodic reports. We assume no obligation and expressly disclaim any duty to
update any forward-looking statement to reflect events or circumstances after
the date of this news release or to reflect the occurrence of subsequent
events.
    %SEDAR: 00003671EF




For further information:

For further information: Michael Watts, Sr. director, investor relations
and corporate communications, (858) 410-8673; Thom Skinner, Chief Financial
Officer, (418) 527-6100, communications@diagnocure.com

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