SOURCE: Ventana Medical Systems, Inc.

May 09, 2005 16:45 ET

TriPath Imaging Receives FDA 510(k) Clearance for Estrogen Receptor and Progesterone Receptor Applications for Ventana Image Analysis System

BURLINGTON, NC and TUCSON, AZ -- (MARKET WIRE) -- May 9, 2005 -- TriPath Imaging, Inc. (NASDAQ: TPTH), and Ventana Medical Systems, Inc. (NASDAQ: VMSI) announced today TriPath Imaging has received 510(k) clearance from the U.S. Food and Drug Administration for the Ventana Image Analysis System (VIAS) when used with tissues stained for Estrogen Receptor (ER) and Progesterone Receptor (PR). As previously announced, Ventana has entered into an agreement to market globally the Ventana-branded interactive histology image analysis system from TriPath Imaging.

"This is clearly a gating event that sets the table for a Ventana launch of VIAS," said Paul R. Sohmer, M.D., Chairman, President, and CEO of TriPath Imaging. "The analysis of ER and PR are the first of what we expect to be an array of applications for our imaging system."

"We are very pleased TriPath Imaging has received 510(k) clearance for VIAS when used with ER and PR and plan to launch the system immediately," stated Christopher Gleeson, President and Chief Executive Officer of Ventana Medical Systems. "Based upon the response we have received from pathologists at the recent scientific conferences, we expect VIAS will be well received in the market."

ER and PR analysis aids in the management of breast cancer patients. ER and PR tests are routinely used by physicians to aid in the prognosis and prediction of therapy outcomes for breast cancer.

About TriPath Imaging, Inc.

TriPath Imaging, Inc., headquartered in Burlington, North Carolina, develops, manufactures, markets and sells innovative solutions to improve the clinical management of cancer, including detection, diagnosis, staging and treatment. TriPath Oncology, a wholly owned subsidiary of TriPath Imaging, develops molecular diagnostic products for malignant melanoma and cancers of the cervix, breast, ovary and prostate. For more information on TriPath Imaging please visit our web site at

About Ventana Medical Systems, Inc.

Ventana develops, manufactures, and markets instrument/reagent systems that automate slide preparation and staining in clinical histology 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.

TriPath Imaging Safe Harbor Statement

Investors are cautioned that statements in this press release that are not strictly historical statements constitute forward-looking statements which involve risks and uncertainties that could cause actual results and outcomes to differ materially from what is expressed in those forward-looking statements. Such forward-looking statements include, without limitation, those related to the development of the interactive histology imaging system, the opportunities provided by the Ventana collaboration, the market acceptance of TriPath Imaging's products, and product development efforts. Important factors that may affect such forward-looking statements include, without limitation: TriPath Oncology may be unable to successfully develop and commercialize products and services when anticipated, if at all; TriPath Imaging's products may not achieve or maintain market acceptance to the degree anticipated; TriPath Imaging and TriPath Oncology's products may not receive FDA or other required regulatory approval when expected, if at all; and other risks detailed in TriPath Imaging's filings with the Securities and Exchange Commission, including those described in TriPath Imaging's Annual Report on Form 10-K for the year ended December 31, 2004.

Ventana Safe Harbor Statement

This press release contains certain forward-looking statements within the meaning of the Federal Securities laws. These forward-looking statements include, but are not limited to, statements regarding the marketing of products and market acceptance of Ventana products. These forward-looking statements are subject to numerous risks and uncertainties, and actual results may vary materially. A full discussion of risks and uncertainties is available in our most recent Annual Report filed with the Securities and Exchange Commission (SEC) on Form 10-K and all subsequent SEC filings. Copies of filings made with the SEC are available through the SEC's electronic data gathering analysis retrieval system (EDGAR) at We undertake no obligation following the date of this release to update or revise our forward-looking statements or to update the reasons actual results could differ materially from those anticipated in forward-looking statements. We caution you not to place undue reliance upon any such forward-looking statements, which speak only as of the date such statements are made. Past performance is not indicative of future results. We cannot guarantee any future operating results, activity, performance, or achievement.

Contact Information

  • Contacts
    TriPath Imaging
    Stephen P. Hall
    Chief Financial Officer
    (336) 290-8721

    Ventana Medical Systems
    Christopher Gleeson
    President and CEO
    (520) 229-3787

    Nick Malden
    Chief Financial Officer
    (520) 229-3857