CINtec^® Histology

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.

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

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

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

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

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.

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

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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.}

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. For technical documentation, or training support, please click here.

BenchMark ULTRA system is Roche Tissue Diagnostics’ most innovative, fully-automated immunohistochemistry and in situ hybridization slide staining system, offering multiple features designed to deliver diagnostic confidence to histopathology laboratories worldwide.

BenchMark GX offers a fully automated baking-through-staining solution with the added flexibility to run any assay side-by-side.

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	-	-	-	✔

BenchMark ULTRA instrument benefits

Fully automated

Standardized IHC and ISH staining
Improve quality, workflow and testing efficiency

Flexibility

Individually controlled slide heater pads enable users to run any assay side-by-side
Customize time and temperature protocols for each individual slide position

Optimal quality

Individual slide heaters, liquid coverslip and air vortex mixers provide an optimal puddle staining environment
Sensitive detection chemistries and a broad portfolio of ready-to-use assays

Workflow

Optimize throughput capacity with single piece workflow
Increase laboratory productivity and reduce re-run rates

BenchMark ULTRA instrument features

30 slide positions
Ability to add or remove bulk reagents and waste without interrupting cases in process
35 reagent positions
Continuous and random slide processing to optimize laboratory workflow

Learn more about the BenchMark ULTRA system

Learn more about BenchMark GX system

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

BenchMark GX offers a fully automated baking-through-staining solution with the added flexibility to run any assay side-by-side.