Healthcare Industry News:  HER2 

Diagnostics Oncology FDA

 News Release - January 18, 2007

Ventana Receives FDA Approval for Rabbit Monoclonal Antibody

TUCSON, AZ--(Healthcare Sales & Marketing Network)--Jan 18, 2007 -- Ventana Medical Systems, Inc. (NASDAQ:VMSI ) today announced it has received approval from the US Food and Drug Administration (FDA) for the use of its PATHWAY® HER-2/neu (4B5) Rabbit Monoclonal Antibody as an aid in the assessment of breast cancer patients for whom Herceptin® treatment is considered. This antibody has also been approved for use on the Ventana Image Analysis System (VIAS(TM)).

The over-expression of HER2 causes breast cancer cells to grow more rapidly and renders customary chemotherapy less effective. Herceptin is a targeted therapy against the HER2 protein on breast cancer cells. PATHWAY® HER-2/neu (4B5) is intended for laboratory use for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue on a Ventana automated immunohistochemistry slide staining device.

"We are pleased with the FDA's decision to approve Ventana's PATHWAY® HER-2/neu (4B5)," said Christopher Gleeson, President and Chief Executive Officer. "This new test provides pathologists and oncologists with an outstanding diagnostic tool and is the result of our continued investment in companion diagnostics. Our PATHWAY® HER-2/neu (4B5) diagnostic test adds to Ventana's existing companion diagnostic portfolio and further enhances the Company's position as a world leader in the development of diagnostic tests that assist physicians in the selection of targeted therapies that have the potential to improve patient care."

Herceptin® (trastuzumab) is manufactured by Genentech, Inc., San Francisco, CA.

About Ventana Medical Systems, Inc.

Ventana Medical Systems develops, manufactures, and markets instrument/reagent systems that automate slide preparation and staining in anatomical pathology and drug discovery laboratories worldwide. Ventana's clinical systems are important tools used in the diagnosis and treatment of cancer and infectious diseases. Ventana's drug discovery systems are used to accelerate the discovery of new drug targets and evaluate the safety of new drug compounds. Visit the Ventana Medical Systems, Inc. website at

Source: Ventana Medical Systems

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