Preclinical feasibility study of NMP179, a nuclear matrix protein marker for cervical dysplasia

OBJECTIVE: To evaluate, in a preclinical feasibility study, the efficacy of NMP179, a monoclonal antibody recognizing a cervical tumor-associated nucl ear matrix antigen,for the early detection of high and low grade cervical i ntraepithelial neoplasia. STUDY DESIGN: In a blind study involving two clinical sites, NMP179 immunoc ytochemical staining data from 261 cervicovaginal ThinPrep(R) specimens wer e evaluated. Assay sensitivity and specificity were calculated based upon a positive threshold of > 10 immunostained cells per case, using cytologic d iagnosis as an end point. RESULTS: Based upon the examination of squamous epithelial cells, NMP179 de tected 96.7% of cases with cytologically diagnosed high grade squamous intr aepithelial lesions (HSIL) and 70.5% of low grade squamous intraepithelial lesions. The antibody also reacted with 29.6% of normal (within normal limi ts or benign cellular changes) smears. CONCLUSION: The NMP179 assay detected HSIL with very high accuracy (96.7%). The assay was 79.3% sensitive for the detection of low and high grade cerv ical intraepithelial neoplasia (grades 1-3), with a specificity of 70.4%. N MP179 may be an effective marker for the early detection of preneoplastic s quamous intraepithelial lesions of the cervix and may be useful as an adjun ctive tool for better management of cervical intraepithelial neoplasia.