TriPath Imaging says study shows ProEx C improves detection of cervical disease

By E. Janene Geiss

Philadelphia, Nov. 7 - TriPath Imaging, Inc. announced Monday that results of a new in-house retrospective research study demonstrated that testing cervical cytology specimens using the company's proprietary ProEx C biomarkers yielded a 93% improvement in sensitivity for detection of biopsy evidence of high-grade cervical intraepithelial neoplasia.

This data and other data relating to the performance of ProEx C biomarkers, along with clinical and research studies using the SurePath liquid based Pap test were presented at the annual scientific meeting of the American Society of Cytopathology, according to a company news release.

The in-house study was designed to evaluate the performance of RUO reagents using ProEx C biomarkers in a retrospective study of 1,600 cervical cytology specimens collected using the SurePath test pack.

The cohort included 939 specimens that had been classified as atypical or abnormal by standard microscopic examination, officials said. The sensitivity of testing with RUO reagents using the ProEX C biomarkers for detection of biopsy evidence of CIN2+ was 96.2%, a 93% improvement when compared to high grade cervical cytology classification of HSIL+ by 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," Johnny Powers, senior vice president, TriPath Oncology, said in the release.

"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," Powers added.

The ProEx C biomarkers are monoclonal antibodies that detect over-expression of proteins 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, officials said.

Burlington, N.C.-based TriPath Imaging develops, manufactures and markets solutions to improve clinical management of cancer, including detection, diagnosis, staging and treatment.

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