# CINtec PLUS Cytology (p16/Ki-67 dual stain)

Source: https://onco.cc/drugs/cintec-plus-cytology/  
OnCo record `cintec-plus-cytology` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A stain on cervical cells that helps decide which women with a positive HPV test need colposcopy, approved by the FDA in 2020.

## Summary

CINtec PLUS Cytology (Ventana Medical Systems, Roche Diagnostics) was approved by the FDA on 10 March 2020 (PMA P190024). It detects p16INK4a and Ki-67 together in cervical specimens in ThinPrep PreservCyt solution, using a mouse monoclonal antibody against p16 (clone E6H4) and a rabbit monoclonal antibody against Ki-67 (clone 274-11AC3V1) on the BenchMark ULTRA instrument. It is indicated in women aged 25 to 65 whose cobas 4800 HPV primary screening test is positive for the 12 other high-risk types, to decide on referral to colposcopy, and for women positive for HPV 16/18; and in women aged 30 to 65 with normal cytology (NILM) and a positive HPV result in co-testing. Results are interpreted by a pathologist.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-04
- Also known as: p16/Ki-67 dual stain; dual stain cytology
- Tags: test; screening-test
- Brand: CINtec PLUS
- Modality: Immunocytochemistry dual-stain test for triage of HPV-positive screens
- Mechanism: Two antibodies detect the proteins p16INK4a and Ki-67 together in the same cervical cells, read by a pathologist.
- Approvals: US 2020: Triage of HPV-positive cervical screening results (cobas 4800) to decide on colposcopy (PMA P190024)

## Sources

- FDA PMA P190024: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190024

## Connected records

- drugs: [cobas HPV test (Roche)](https://onco.cc/drugs/cobas-hpv/), [ThinPrep Pap Test and ThinPrep processors (Hologic)](https://onco.cc/drugs/thinprep/)
- collections: [FDA medical device databases (PMA, 510(k), De Novo)](https://onco.cc/collections/fda-device-databases/)
- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [HPV DNA testing and self-sampling](https://onco.cc/technologies/hpv-testing/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- terms: [Cervical precancer (CIN, HSIL/LSIL)](https://onco.cc/terms/cin-hsil/), [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/), [Screening](https://onco.cc/terms/screening/)

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