PATHWAY(TM) Assists in Accurate and Rapid Identification of Breast Cancer
Patients for Herceptin(R) Therapy
TUCSON, Ariz., Nov. 30 /PRNewswire/ -- Ventana Medical Systems, Inc.
(Nasdaq: VMSI), the leading company in supplying automated instrument-reagent
systems to histology and drug-discovery labs, today announced that the U.S.
Food and Drug Administration (FDA) issued a pre-market approval (PMA) on its
CB11 antibody for Her 2/neu diagnostic testing. Ventana Medical System's
PATHWAY(TM) Her 2 (clone CB11) is a monoclonal antibody intended for
laboratory use for the detection of c-erbB-2 antigen in routine pathological
samples on Ventana automated immunohistochemistry (IHC) slide-staining
devices. It is indicated as an aid in the assessment of breast cancer
patients who could benefit from Genentech's (NYSE: DNA) Herceptin(R) therapy.
PATHWAY(TM) is a very specific and highly sensitive monoclonal antibody
that outperforms other tests that utilize polyclonal antibodies to detect the
overexpression of c-erbB-2 antigen in breast cancer. Data presented at the
San Antonio Breast Cancer Conference late last year and at the annual meeting
of the American Society of Clinical Oncologists in May 2000 by the M.D.
Anderson Cancer Center in Houston and Memorial Sloan-Kettering in New York
showed a very high correlation between CB11 and breast cancer patients'
responses to Herceptin(R).
Francisco J. Esteva, assistant professor of medicine at the University of
Texas, M.D. Anderson Cancer Center commented, "CB11 was an excellent predictor
of response to Herceptin(R)-based therapy in patients with metastatic breast
cancer. In a Phase II clinical study of Herceptin(R) administered in
combination with weekly Taxol, CB11 was a superior predictor of response to
the therapy."
PATHWAY(TM) was FDA-approved for use on any of Ventana's family of
automated instrument platforms including ES, NexES and the new BenchMark(TM).
Because Ventana has a large installed base of instruments, the test will be
readily accessible to breast cancer patients and the physicians who treat
them.
"All of us at Ventana are committed to our partnerships with the medical
and pharmaceutical community by providing unique diagnostic tests that will
assist in improving the practice of medicine and thus the quality of patient
care. This is the first in a series of new tests from Ventana that will link
a specific disease-focused diagnostic to relevant therapy," said Christopher
Gleeson, Ventana's president and chief executive officer.
"All of our customers will be able to use their IHC automated
slide-staining systems to better assess the status of the breast cancer
patients they serve," Gleeson added. "With time to treatment being a critical
factor in the fight against breast cancer, these laboratories will be able to
deliver consistent and reliable results within four hours of receiving the
tissue biopsy."
Ventana expects to ship its first tests to customers on December 6, 2000.
Ventana develops, manufactures and markets instrument/reagent systems that
automate tissue preparation and slide staining in clinical and drug discovery
laboratories worldwide. Ventana's systems are important tools used in the
diagnosis and treatment of cancer and infectious diseases. In addition,
Ventana has recently entered the exciting new field of genomics, assisting in
the identification of genetic pathways to the treatment of diseases. The
valuable information gained from tracking nucleic acids with Ventana products
provides the basis for the development of both life-enhancing and life-saving
commercial drugs.
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.
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".
Or visit the Ventana Medical Systems, Inc. website at http://www.ventanamed.com .
The Molecular Discovery Systems Division has its own website
at http://www.ventanadiscovery.com .
SOURCE Ventana Medical Systems Inc.
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Related links:
http://www.ventanamed.com
CONTACT:
Christopher Gleeson, President and Chief
Executive Officer of Ventana Medical Systems Inc., 520-887-2155;
or Analysts, Kathy Brunson, 312-640-6696, or General, Marilyn
Windsor, 312-640-6692, both of The Financial Relations Board
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