TUCSON, Ariz., Jan. 21 /PRNewswire/ -- Ventana Medical Systems, Inc.
(Nasdaq: VMSI) announced that it had submitted to the Food and Drug
Administration (FDA) a pre-market approval application (PMA) for its CB11
antibody that physicians could use in deciding whether metastatic breast
cancer patients should receive Herceptin(R).  Herceptin(R) is a drug marketed
by Genentech that has been approved for use by the FDA in metastatic breast
cancer patients that test positive for Her-2/neu receptor overexpression.
    Chris Gleeson, President & CEO of Ventana stated, "Approval of this PMA
will enable all of our customers to use their automated Ventana
immunohistochemistry systems to better assess the status of breast cancers
based on specific molecular characteristics.  The CB11 test will help
Oncologists plan an optimal therapeutic approach for breast cancer patients
and predict future response to therapy.  Approval of our CB11 antibody will
complement our already FDA approved estrogen receptor, progesterone receptor
and ki-67 tests which are widely utilized in analyzing breast cancers."
    Dr. Francisco Esteva of the M. D. Anderson Cancer Center in Houston
reported on recent work completed at M.D. Anderson and Memorial Sloan
Kettering Cancer Centers.  "We believe that CB11 is a particularly useful
antibody, better at predicting response to Herceptin(R) therapy than
polyclonal antibodies to HER-2/neu.  Our study concluded that monoclonal
antibodies, like CB11, and FISH (fluorescent in-situ hybridization) may be the
best predictors of therapeutic response."  This work was presented at the
recent 22nd Annual San Antonio Breast Cancer Symposium.
    Ventana already markets a FDA approved manual FISH test for measuring
Her-2/neu gene overexpression under the Inform(R) name.  Mr. Gleeson added,
"Our PMA submission for CB11 approval together with our existing Inform(R)
test demonstrates Ventana's commitment to women's health care and providing
anatomical pathologists with the tools they need to help oncologists formulate
an appropriate therapeutic strategy for breast cancer patients."
    Safe Harbor Statement: Statements in this press release which are not
strictly historical are "forward-looking" statements that are made pursuant to
the Safe Harbor provisions of the Private Securities Litigation Reform Act of
1995.  Forward-looking statements involve known and unknown risks, which may
cause the company's actual results in the future to differ materially from the
expected results.  The risks and uncertainties that may affect the results of
the company's business may include general economic conditions, market
acceptance of new automated histology products, continued success in asset
management and other factors that are described in the company's specific
filings with the Securities and Exchange Commission.
    Ventana develops, manufactures and markets instrument/reagent systems that
automate tissue preparation and slide staining in histology laboratories
worldwide.  Ventana's systems are important tools used in the diagnosis and
treatment of cancer and infectious diseases.
    For more information on Ventana Medical Systems, Inc. via facsimile at no
additional cost, simply dial 1-800-PRO-INFO and enter the stock symbol "VMSI".

Link to this page: