Step 1: click on the link below to go to Roche DiaLog.
Step 2: select eLabDoc from eServices.
Step 3: select the Catalog for Healthcare Professionals and search.
The CINtec® Histology test is the only CE-IVD p16 biomarker for clinical/IVD use in the evaluation of cervical biopsy specimens.
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 |
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.
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 |
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 | - | - | - | ✔ |
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
* Please check with your local Roche representative about product availability in your area; some products may not be available in all countries.
Step 1: click on the link below to go to Roche DiaLog.
Step 2: select eLabDoc from eServices.
Step 3: select the Catalog for Healthcare Professionals and search.
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.
Rated #1 for staining quality and platform reliability, this fully automated instrument offers 30 independent slide drawers and single-piece workflow—supporting the largest menu of 250+ ready-to-use assays.
For laboratories seeking to optimize efficiency and increase scale, the BenchMark GX IHC/ISH system offers a small footprint with proven automation to help oncology caregivers deliver diagnostic confidence.
