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

Tissue Reagents Cervical Diagnostics

Cervical Diagnostics

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Overview

Bringing Scientific Certainty to Cervical Pathology

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 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

CINtec® Histology is a qualitative immunohistochemistry (IHC) test using mouse monoclonal anti-p16 antibody clone E6H4, and is intended for use in the light microscopic assessment of the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues using OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument. The test is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of cervical intraepithelial neoplasia (CIN). Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information.

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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