Gen-Probe and DiagnoCure amend collaboration agreement surrounding PCA3-based prostate cancer tests



    Gen-Probe invests US$5 million in DiagnoCure

    SAN DIEGO, CA, and QUEBEC CITY, April 29 /CNW Telbec/ - Gen-Probe
Incorporated (NASDAQ:   GPRO) and DiagnoCure Inc. (TSX: CUR) today announced
that the companies have signed an amendment to their 2003 license agreement,
establishing new FDA submission milestones and key distribution arrangements
to leverage the full market potential of the PCA3-based test for prostate
cancer in the United States, Europe and around the world.
    As part of the amendment, Gen-Probe will acquire 4.9 million shares of
newly issued DiagnoCure convertible preferred stock for US$5.0 million (C$6.1
million), representing a premium of 19.8% over the average market price of the
common shares of DiagnoCure during the 20 trading days from yesterday, subject
to DiagnoCure securing the required regulatory approvals from the Toronto
Stock Exchange. These convertible preferred shares are non-voting, and may be
exchanged for common shares on a one-for-one basis. DiagnoCure has the option
to redeem the preferred shares or to require their conversion into common
shares in certain circumstances. As part of its investment in DiagnoCure,
Gen-Probe will receive a liquidation preference in certain cases and a
security interest in some intellectual property. This subscription will take
place on or around May 7th 2009 and will be completed pursuant to a statutory
prospectus and registration exemptions.
    The new milestones for an FDA submission of a PCA3 test can be fulfilled
by Gen-Probe with its current end-point TMA assay or its investigational,
real-time TMA assay. As part of the contract amendment, Gen-Probe will make
annual payments of US$500,000 to DiagnoCure until specific milestones are met.
Half the amounts paid will be applied against future royalties payable to
DiagnoCure.
    Also, in an effort to maximize the global reach for the PCA3 prostate
cancer test, DiagnoCure and Gen-Probe have agreed on terms to develop key
distributor relationships in countries where it is commercially more effective
to do so, such as in Japan, Asia, Israel, South Africa and others.
    In a separate press release today, Gen-Probe announced that it intends to
initiate in the third quarter of 2009 a pivotal clinical study of its
investigational PCA3 assay that could lead to regulatory approval by the U.S.
Food and Drug Administration (FDA).

    About PCA3

    PCA3 is a molecular marker that studies indicate is more specific for
prostate cancer than the commonly used diagnostic test, PSA (prostate specific
antigen). PCA3 has been the subject of approximately 17 peer-reviewed
publications over the past few years. A PCA3-based test, PROGENSA(R) PCA3, is
now commercialized by Gen- Probe in Europe under the CE mark. In the United
States, the test is not yet approved for commercialization by the FDA.

    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 25 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 1,200 people. For more
information, go to www.gen-probe.com.

    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.,
launched in 2008 the Previstage(TM) GCC Colorectal Cancer Staging Test, the
first GCC-based molecular test for the management of colorectal cancer. A
major study published in the February 18, 2009, edition of the JAMA ("Journal
of the American Medical Association") demonstrated that GCC is the strongest
independent predictor of colorectal cancer recurrence in patients considered
low risk by current assessment methods. 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)
manufactured by 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.

    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 and customer adoption 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 new prostate
cancer products, including those based on PCA3, will not be cleared for
marketing in the timeframes we expect, if at all, (ii) the risk that
development of these products will not be successful, (iii) the possibility
that the market for the sale of these products 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 the companies face and a discussion
of financial statements and footnotes, for Gen-Probe, see documents filed with
the SEC, including Gen-Probe's most recent annual report on Form 10-K and all
subsequent periodic reports, and for DiagnoCure, see documents filed on SEDAR,
including the general risks and uncertainties in the most recent Annual
Information Form under the heading "Risk Factors." 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, Vice President, Investor
Relations and Corporate Communications, Gen-Probe Incorporated, (858)
410-8673; J.F. Bureau, CFA, Sr Vice President and CFO, DiagnoCure Inc., (418)
527-6100, communications@diagnocure.com

Organization Profile

DiagnoCure Inc.

More on this organization


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890