CINtec® Histology is 510(k) cleared for use on the
VENTANA BenchMark ULTRA automated slide staining instrument.

Tissue Reagents Cervical Diagnostics

 

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Overview

Bringing Scientific Certainty to Cervical Pathology

The Roche and Ventana cervical cancer portolio helps protect women from cervical cancer and from overtreatment. CINtec® products, available exclusively from Roche 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 in conjunction with Hemotoxylin and eosin staining, the CINtec® products empower you to make informed 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. With the CINtec® Histology test, you can be confident in diagnosing the presence of high-grade disease (CIN2+).

CINtec® p16 Histology — Seeing beyond H&E in cervical cancer diagnostics

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 recommendations1 as well as a major Pan-European clinical study2 support the scientific and medical value of the CINtec® p16 Histology product for use in cervical biopsy specimens.

References
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

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