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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

Related information

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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

increase in identifying disease icon

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.

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    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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