Healthcare Industry News:  HER2 DNA Probe Assay 

Diagnostics Oncology FDA

 News Release - October 3, 2007

Ventana Submits INFORM(TM) HER2 SISH DNA Probe Assay for FDA Approval

Completes Next Step in Bringing Revolutionary INFORM(TM) HER2 SISH Technology to the U.S.

TUCSON, Ariz.--(HSMN NewsFeed)--Ventana Medical Systems, Inc. (NASDAQ: VMSI ), the global leader in tissue-based cancer diagnostics, today announced that it has submitted its INFORM(TM) HER2 DNA Probe Assay to the Food and Drug Administration (FDA) for approval to market the product in the United States. The Test detects HER2 gene amplification through proprietary Silver in situ Hybridization (SISH) technology. Ventana's HER2 SISH technology is currently used in Europe, Canada, Asia, and Australia.

Ventana's INFORM(TM) HER2 SISH DNA probe test is designed to qualitatively and quantitatively detect amplification of the HER2 gene in human breast cancer tissue specimens following staining on Ventana automated slidestainer instruments using light microscopy. This probe would be used as an aid in the assessment of patients for whom Herceptin® (Trastuzumab) treatment is being considered.

INFORM(TM) HER2 SISH would provide several significant benefits, giving pathologists enhanced tools for a timely and accurate diagnosis. These benefits include:
  • Same Day Results - INFORM(TM) HER2 SISH is performed in less than half the time required for FISH technologies and allows for same day results (within 6 hours).
  • Full Automation - INFORM(TM) HER2 SISH is the only fully automated chromogenic in situ hybridization assay for HER2 gene and chromosome 17 detection, which uses pre-formulated reagents that are "ready to use."
  • Simplified Interpretation - Results can be more precisely determined and morphological significance can be easily interpreted using conventional bright field microscopy (versus costly florescent microscopy) with INFORM(TM) HER2 SISH.
  • Slide Archiving - INFORM(TM) HER2 SISH provides the unique ability to archive slides, allowing for the possibility of re-examination and discussion at a later date.
Christopher Gleeson, President and Chief Executive Officer of Ventana, stated, "With our clinical trials successfully completed, this submission is a big step towards providing efficient access to the latest technological advances in breast cancer pathology and prognostics to pathologists around the world. We are excited by the prospect of offering pathologists in the U.S. a substantial improvement over current fluorescent methodologies to quickly determine which patients will respond to Herceptin® therapy with INFORM HER2 SISH."

Gleeson continued, "We look forward to being able to introduce this ground breaking technology to the United States as part of our ongoing commitment to leading innovation in tissue-based cancer diagnostics and the rapidly growing and enormously valuable area of companion diagnostics."


Ventana develops, manufactures, and markets instrument/reagent systems that automate tissue preparation and slide staining in clinical histology and drug discovery laboratories worldwide. The Company'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.

For more information on Ventana Medical Systems, Inc. visit


This press release may contain certain forward-looking statements within the meaning of the federal securities laws. The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those expected, depending on a variety of factors, such as risks associated with the development, manufacturing, marketing, and sale of medical products, competitive factors, general economic conditions, legal disputes, and government actions. There can be no assurances the FDA will grant marketing approval or on the timing of any FDA actions. Please refer to our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), and all subsequent SEC filings, for a more detailed discussion of applicable risks and uncertainties.

Source: Ventana Medical Systems

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