Cervical disease diagnostics

The Roche and Ventana cervical cancer portolio helps protect women from cervical cancer and from overtreatment. CINtec® products, available exclusively from Roche and Ventana Medical Systems, Inc., are the only IVD (in vitro diagnostics) products to detect the overexpression of the cellular protein p16INK4a (p16) in cervical cytology and tissue specimens. Used adjunctively with available clinical information, the CINtec® products empower you to make informed, confident decisions.

The over-expression of p16 (a cyclin-dependent kinase inhibitor) in cervical specimens, detected by CINtec® immunohistochemistry products, is highly correlated with oncogenic transformation caused by persistent high-risk HPV (hrHPV) infections.

The CINtec® p16 Histology product is part of a fully automated immunohistochemistry (IHC) assay for the qualitative detection of the p16 protein on slides prepared from formalin-fixed, paraffin-embedded cervical biopsies. Over 100 publications, medical society recommendations (1) as well as a major Pan-European clinical study (2) support the scientific and medical value of the CINtec® p16 Histology product for use in cervical biopsy specimens.

CINtec® PLUS Cytology* immunocytochemistry assay provides simultaneous qualitative detection of p16 and Ki-67 proteins in cervical cytology preparations. This advanced combination of biomarkers provides high sensitivity and high specificity in a single test. CINtec® PLUS Cytology identifies underlying high-grade cervical disease in cytology specimens and helps identify women with transforming cervical lesions (p16/Ki-67 positive) who need colposcopy (3,4,5).

*CINtec® PLUS Cytology is a CE/IVD product, approved for clinical use. CINtec® PLUS Cytology is not available for this use in the United States. Check with your local Roche representative for the availability of products in your region and the applicable intended use.


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References for CINtec® PLUS Cytology


  1. Darragh TM, Colgan TJ, Cox T, et al. The Lower Anogenital Squamous Terminology Standardization Project for HPV-Associated Lesions: Background and Consensus Recommendations from the College of American Pathologists and the American Society for Colposcopy and Cervical Pathology. Arch Pathol Lab Med. 2012; 136 (10): 1266-97.

  2. Bergeron C. Ordi J, Schmidt D, et al. European CINtec Histology Study Group. Conjunctive p16INK4a Testing Significantly Increases Accuracy in Diagnosing High-Grade Cervical Intraepithelial Neoplasia. Am J Clin Pathol. 2010; 133: 395

  3. Petry KU, Schmidt D, Scherbring S, et al. Triaging Pap cytology negative, HPV positive cervical cancer screening results with p16/Ki-67 dual-stained cytology. Gynecol Oncol. 2011; 121(3): 505-509

  4. Schmidt D, Bergeron C, Denton KJ, et al. European CINtec Cytology Study Group. P16/Ki-67 dual-stain cytology in the triage of ASCUS and LSIL Papanicolau cytology: results from the European equivocal or mildly abnormal Papanicolau cytology study. Cancer Cytopathol. 2011; 119(3): 158-166

  5. Wentzensen N, Schwartz L, Zuna RE, et al. Cancer Precursors in a Colposcopy Referral Population. Performance of p16/Ki-67 immunostaining to Detect Cervical Cancer and Precursors in a Colposcopy Referral Population. Clin Cancer Res. 2012; 18: 4154-4162