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.
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References for CINtec® PLUS Cytology
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.
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
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
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
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