TPTH Tripath Imaging

Results from an External Research Study Presented at San Antonio Breast Cancer Symposium BURLINGTON, N.C., Dec. 12 /PRNewswire-FirstCall/ -- TriPath Imaging, Inc. (NASDAQ:TPTHNASDAQ:-NASDAQ:News) today announced that data generated from an external research study conducted at the Albany Medical College using the Company's proprietary ProEx(TM) Br biomarkers demonstrate a strong correlation between biomarker reactivity and the risk of disease recurrence within five years from initial diagnosis of early stage breast cancer. This research study included 217 archived breast tissue specimens from a retrospective cohort of patients with early stage breast cancer who had been followed for a minimum of five years following initial diagnosis. The research study included quantitative image analysis of the ProEx Br biomarkers utilizing an early version of the Ventana Image Analysis System (VIAS). The results of this study were presented at the 28th Annual San Antonio Breast Cancer Symposium held in San Antonio, Texas. In this retrospective study of archived breast tissue samples from patients with early stage breast cancer, researchers from Albany Medical College reported that the rate of breast cancer recurrence within five years of initial diagnosis was approximately 30% when archived breast tissue tested negative for all ProEx Br biomarkers and approximately 40% when positive for one or fewer ProEx Br biomarkers. When the archived breast tissue tested positive for two or more of the five ProEx Br biomarkers included in this research study, the rate of recurrence increased to up to approximately 70%. Multivariant Cox proportional analysis (Hazard Ratio) of the data collected in this study indicated a two-fold increase in the calculated risk of breast cancer recurrence within five years from initial diagnosis when testing with two or more of the ProEx biomarkers was positive (p value = 0.0141) as compared to the calculated risk of recurrence when testing was negative for all ProEx Br biomarkers. In their presentation, the researchers concluded that the ProEx Br biomarkers provided independent prognostic information regarding recurrence of breast cancer and that these data support the potential utility of the ProEx Br biomarkers to risk stratify early stage, lymph node negative breast cancer patients. Dr. Jeffrey S. Ross, M.D., the Cyrus Strong Merrill Professor and Chair Department of Pathology and Laboratory Medicine Albany Medical College commented, "The ProEx Br biomarkers were straight forward and easy to use in our laboratory during this research study. The VIAS system was similarly easy to operate. We are encouraged with the results of our study and plan to continue to use the ProEx Br system in our breast cancer research program." "The results from this external research study are consistent with those that we have previously reported from our own internal studies in which we retrospectively evaluated the correlation of the ProEx Br biomarkers with the risk of breast cancer recurrence within ten years from initial diagnosis of early stage breast cancer," commented Dr. Douglas Malinowski, TriPath Imaging Vice President and Chief Scientific Officer. "As screening procedures continue to improve, breast cancer is being detected at an earlier stage where the tumors are relatively small and the cancer has not yet spread to the lymph nodes. We targeted our biomarker discovery process to identify biomarkers that would help physicians better identify those early stage breast cancer patients who are at a higher risk of recurrence and, therefore, may potentially benefit from more aggressive therapy. " "We believe that the results from this new external study, along with previously reported results from our internal studies, provide an early indication of the utility of these biomarkers" said Dr. Johnny Powers, Senior Vice President of TriPath Oncology. "Given these very compelling results, we have completed the development of a version of the ProEx Br biomarkers for use on the Ventana BenchMark XT automated staining system. In addition, we recently initiated a clinical trial to generate data to support a submission to the FDA." About ProEx Br Biomarkers The ProEx Br biomarkers are monoclonal antibodies that are designed to detect over- expression of unique cellular proteins that are predictive of breast cancer recurrence. These biomarkers were selected after an exhaustive discovery and validation process completed in 2004. For the purpose of the external research study, the ProEx biomarkers were incorporated into Research Use Only reagents designed to detect the over-expression of these proteins. 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/. 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 ProEx Br biomarkers. 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; clinical trials may yield results for product candidates incorporating the ProEx Br biomarkers that differ from the results of our in-house and external research studies; 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. Contact Stephen P. Hall, Chief Financial Officer TriPath Imaging 336-290-8721 DATASOURCE: TriPath Imaging, Inc. CONTACT: Stephen P. Hall, Chief Financial Officer, TriPath Imaging, +1-336-290-8721 Web site: http://www.tripathimaging.com/

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