TriPath Imaging Inc. (Nasdaq: TPTH) and Ventana Medical Systems, Inc. (Nasdaq: VMSI), announced today that TriPath Imaging has received 510(k) clearance from the U.S. Food and Drug Administration for the Ventana Image Analysis System (VIAS(TM)) when used with tissues stained for p53. In 2005 and 2006, the Companies announced 510(k) clearances for VIAS when used with the Ventana Estrogen Receptor (ER), Progesterone Receptor (PR), Ki-67 and HER- 2/neu assays.
p53 is a tumor suppressor biomarker which is employed by pathologists as an adjunct to histopathology and is used to assist with diagnosis and the prognostic assessment of cancer. Research studies have shown that high expression levels of the p53 protein have been associated with more aggressive breast cancers. Precise quantitative measurement of p53 expression in breast biopsy samples may be used to aid in the over-all management and treatment selection of breast cancer patients. VIAS is ideally suited to provide this level of biomarker quantification.
“FDA clearance for the analysis of p53 increases the clinical utility of VIAS as an aid to the anatomical pathologist. This is the first time the p53 marker has been cleared by the FDA for use with an image analysis system,” said Paul R. Sohmer, M.D., Chairman, President, and CEO of TriPath Imaging. “We expect to continue to further expand the application menu supported by VIAS with additional 510(k) applications.”
“We are pleased that TriPath Imaging has obtained this clearance,” stated Christopher Gleeson, President and Chief Executive Officer of Ventana Medical Systems. “This expands our VIAS menu and, together with the previous clearances for ER, PR, Ki-67 and HER-2/neu, enables us to provide further value to pathologists.”
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 http://www.tripathimaging.com.
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, including expected additional 510(k) applications, 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, 2005.
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 http://www.sec.gov. 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.