BURLINGTON, N.C., Nov. 7 /PRNewswire-FirstCall/ -- TriPath Imaging, Inc. today announced that the results of a new in-house retrospective research study demonstrated that testing of cervical cytology specimens with Research Use Only (RUO) reagents incorporating the Company’s proprietary ProEx C biomarkers yielded a 93% (p<0.0001) improvement in sensitivity for detection of biopsy evidence of high grade cervical intraepithelial neoplasia (CIN2+) when compared to a high grade abnormal cytology classification of HSIL+. The results of this retrospective research study also demonstrated a 65% improvement in calculated Positive Predictive Value for detection of CIN2+ when compared to all atypical and abnormal cytology classifications combined, defined as ASCUS and higher (ASCUS+).
These and other data relating to the performance of the ProEx C biomarkers as well as an array of clinical and research studies incorporating the SurePath liquid based Pap test were presented at the 53rd Annual Scientific Meeting of the American Society of Cytopathology (ASC) in San Diego, California. In conjunction with the meeting, the Company is also sponsoring two symposia entitled “A New Era in Cervical Cytology: Revealing Clues from the Cell-Cycle” and “Molecular Technology for the Cytology Lab: Initial Impressions of In-House Use of ProEx C”.
Data from In-House Research Is Consistent with Previously Reported External Research Studies
In a platform presentation made to the plenary session of the ASC meeting, Adriann Taylor, Director of Product Development at TriPath Oncology, discussed the results of a new in-house research study that was designed to evaluate the performance of RUO reagents incorporating ProEx C biomarkers in a retrospective study of 1,600 cervical cytology specimens collected using the SurePath test pack. This retrospective cohort included 939 specimens that had been classified as atypical or abnormal (ASCUS+) by standard microscopic examination. For the purpose of this retrospective research study, the ProEx C biomarkers were incorporated into RUO reagents designed to cytochemically distinguish the presence of the over-expression of proteins associated with aberrant S-phase induction in cervical smears that have been classified as atypical or abnormal according to the generally accepted Bethesda 2001 System for classification of cytologic morphology.
In this pre-clinical research study, the sensitivity of testing with RUO reagents incorporating the ProEx C biomarkers for detection of biopsy evidence of CIN2+ was 96.2%, a 93% improvement (p<0.0001) when compared to classification of HSIL+ by microscopic examination. The calculated Positive Predictive Value (PPV) for biopsy-confirmed CIN2+ reflected a 65% improvement in the PPV when compared to microscopic examination.
These data are consistent with the results of external retrospective research studies that were presented in September at the European Congress of Cytology in Paris. In these retrospective studies from the Johns Hopkins Medical Institutions and the Massachusetts General Hospital, the results demonstrated an improvement of 70.6% and 95%, (p=0.0015, p=0.0002), respectively, in sensitivity for detection of biopsy evidence of CIN2+ and an improvement of calculated Positive Predictive Value of 113% and 136%, respectively, when compared to microscopic examination.
“The results of our relatively large retrospective study with RUO reagents incorporating the ProEx C biomarkers are wholly consistent with previously reported results,” said Johnny Powers, PhD., Senior Vice President, TriPath Oncology. “These research studies further demonstrate the correlation between detection of aberrant S-phase induction with our ProEx C biomarkers and biopsy evidence of high grade cervical disease.”
External and In-House Research Studies Address Analytical Performance, Workflow, Impact on Microscopic Examination, and Specific Biomarker Performance
In addition to the large retrospective in-house study, six additional studies were presented at the ASC meeting. Investigators from the Johns Hopkins Medical Institutions and the University of Colorado reported virtually no variability with regard to scoring and staining reproducibility when using a “home brew” version of the ProEx C Analyte Specific Reagent (ASR). These researchers further concluded that their “home brew” assays were unaffected by routine laboratory environment factors in these studies. In a separate study, investigators from Johns Hopkins Medical Institutions observed that testing with the ProEx C biomarkers may assist with the detection of cytologic abnormalities on microscopic examination. Studies from the Company’s in-house research staff addressed assay automation and the performance of specific constituent biomarkers.
“We are very pleased with the results of these very practical studies,” said Timothy Fischer, TriPath Imaging’s Vice President of Product Development. “These studies provide early validation of our efforts to develop a product that will be robust, easy to use and can be readily introduced into the routine laboratory setting. Analytical performance and adaptability to routine laboratory workflow will be critical determinants of the commercial success of our products.”
About the ProEx C Biomarkers
The ProEx C biomarkers are monoclonal antibodies that detect over- expression of proteins that is associated with aberrant S-phase induction, an abnormal growth state that has been associated with cancer of the cervix, esophagus, skin, prostate, ovary and colon. These biomarkers were identified as the result of an outcome driven gene discovery analysis of cervical neoplasia that was completed in 2003.
Analyst Day
Immediately following its third quarter earnings conference call on November 10th, the Company will host an Analyst Day conference in New York City. Management will review the results of research studies employing the Company’s ProEx C molecular markers that were presented in conjunction with the October meeting of the European Congress of Cytology in Paris and the November meeting of the American Society of Cytopathology in San Diego. This review will include the results of studies performed by investigators from three major academic centers as well as the results of new in-house research studies. The Company will also review the potential clinical and commercial value of its developing pipeline in the area of molecular diagnostic products and imaging systems.
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 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 C biomarker and the analyte specific reagent for detection of aberrant S phase induction. 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 C 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
TriPath Imaging, Inc.
CONTACT: Stephen P. Hall, Chief Financial Officer of TriPath Imaging,Inc., +1-336-290-8721
Web site: http://www.tripathimaging.com/
