p16 immuno-cytochemistry shows superior clinical performance to High-risk Human Papillomavirus (HR-HPV) testing for the identification of high-grade cervical intraepithelial neoplasia (CIN) harbored in Atypical Squamous Cells of Undetermined Significance (ASC-US) and Low-grade Squamous Intraepithelial Lesion (LSIL) Papanicolau test (Pap) cytology cases.

The two Pap cytology categories are particularly difficult to interpret because although the majority of cases are benign, up to 15 % of women with such a cytology result harbor high-grade CIN disease, the immediate pre-cursor to cervical cancer.

Two kits contain a specifically designed antibody (clone E6H4TM) and customized secondary reagents with protocols, developed and optimized for immunochemistry applications in cervical histology (CINtec Histology) and cytology specimens (CINtec Cytology). A newly launched kit, CINtec PLUS is a screening and diagnostic tool based on the codetection of p16 plus Ki-67 (a proliferation marker) that combines high sensitivity and high specificity for detecting high-grade cervical disease in a single test.

The performance of p16INK4a immuno-cytochemistry (p16 Cytology) and HPV testing was analyzed on a series of 810 retrospectively collected ASC-US and LSIL cases. The sensitivity (ability to find established disease) of the two tests was similar. However, the specificity of p16 Cytology was up to two times higher than that of HPV testing. This means that significantly fewer women would need to be sent on for further diagnostic follow-up, while still being able to identify those with established high-grade disease.

The study was published in the American Journal of Clinical Pathology on June 17, 2010.

mtm laboratories AG (Heidelberg, Germany) is a certified developer and manufacturer of in vitro diagnostic devices for use in the early detection and diagnosis of cervical cancer. Its family of products is based on the E6H4TM antibody clone, which was specifically developed for immunochemistry applications in cervical histology and cytology specimens. The target for mtm's cervical cancer early detection technology platforms is the evaluation of the overexpression of the cyclin-dependent kinase inhibitor p16INK4a. The overexpression of this biomarker is directly correlated to the oncogenic activity of HR-HPV that marks the generation of cervical cancer.

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