CINtec® Histology

The CINtec® Histology test is an immunohistochemistry p16 biomarker test that is run on the BenchMark ULTRA IHC/ISH system, as well as BenchMark GX and the legacy Benchmark XT system.

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
Man looking at microscope

Cervical cancer portfolio resources

Access our online pathologist/cytotechnician training modules and other support resources.

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

diagnostic consistency icon

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

Ordering information


CINtec® Histology -  U.S. 510(k)

  System Compatiblity

Product Name**

Material
Number
Number
of 
Tests
BenchMark
ULTRA 
BenchMark XT   BenchMark GX Manual/Semi-
automated
Processors

CINtec® Histology

06680003001 50 - - -

CINtec® Histology

06680011001 250 - - -

CINtec® p16 Histology -  CE/IVD

  System Compatiblity

Product Name**

Material
Number
Number
of 
Tests

BenchMark
ULTRA 

BenchMark XT   BenchMark GX Manual/Semi-
automated
Processors

CINtec® p16 Histology (Except China, Thailand and Japan)

06695248001 50 -

CINtec® p16 Histology (Except China, Thailand and Japan)

06695256001 250 -

CINtec® p16 Histology (CE/IVD in China and Thailand; RUO in Japan)

06695221001 50 - -

CINtec® Histology Kit - CE/IVD, Canada Class II and Japan RUO

  System Compatiblity

Product Name**

Material
Number
Number
of 
Tests
BenchMark
ULTRA 
BenchMark XT   BenchMark GX Manual/Semi-
automated
Processors

CINtec® Histology Kit (Except Canada and Japan)

06594441001 50 - - -

CINtec® Histology Kit (Class II in Canada and RUO Japan)

06594450001
50 - - -

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

** Please check with your local Roche representative about product availability in your area; some products may not be available in all countries.

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.