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CINtec® Histology

US-FDA

IVD For in vitro diagnostic use.
CINtec Histology slide

CINtec® Histology: be conclusive in diagnosing cervical precancer

CINtec® Histology provides objectivity to diagnostic interpretation that helps all pathologists identify more cervical disease. The CINtec® Histology test is the only p16 biomarker test CE marked and U.S. 510(k) cleared for clinical use in the evaluation of cervical biopsy specimens. Pathologists who use CINtec® Histology demonstrate improved diagnostic consistency and diagnostic agreement between each other and with expert gynecopathologists.1

CINtec® Histology enhances identification of occult lesions that may be missed by H&E or morphologic interpretation alone, adding objectivity to cervical biopsy interpretation to help pathologists make informed diagnoses. The adjunctive use of CINtec® Histology helps pathologists ensure the right patient is treated without unnecessarily treating more patients.

CINtec® Histology helps aid diagnostic interpretation of high grade cervical disease in tissue biopsy specimens

When CINtec® Histology is used according to the LAST recommendations*:

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Diagnostic sensitivity improves by 11.8% and specificity improves by 9.7% to identify high-grade cervical disease1

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Diagnostic consistency for high-grade disease of challenging cases by the majority of pathologists improves by 29.5%1

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Pathologists who use CINtec® Histology demonstrate improved diagnostic consistency with each other and with expert gynecopathologists.1

* Diagnostics performance by individual pathologists compared with the consensus diagnosis established by expert gynecopathologists using H&E along with CINtec® Histology.

References

  1. Bergeron C, Ordi J, Schmidt D, Trunk MJ, Keller T, Ridder R, et al. Conjunctive p16INK4a Testing Significantly Increases Accuracy in Diagnosing High-Grade Cervical Intraepithelial Neoplasia. Am J Clin Pathol. 2010;133(3):395–406.

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