New Release: Cytoreader V2 is now available! Read our latest paper: Preprint Link

The AI Platform for Reproducible, High-Throughput Dual-Stain Cytology

Cytoreader provides a validated, end-to-end digital solution to increase efficiency and standardization in your laboratory.

For research and internal quality monitoring purposes only. Not CE-IVD. Not for clinical diagnostic use.

Seamless Integration

Hamamatsu Scanners

Validated By

Peer-Reviewed Research

In Daily Use At

Kaiser Permanente

Core Technology

Patented AI Algorithms

The Challenge & The Solution

Overcoming the Limitations of Manual Dual-Stain Review

Cervical cancer screening increasingly relies on primary HPV testing, which enables large-scale automation but lacks specificity. p16/Ki-67 dual-stain (DS) cytology is now widely used for triage due to its improved accuracy over Pap cytology—detecting more precancers while reducing unnecessary colposcopies. However, DS brings challenges: manual review is slow, staining varies, and workflows remain analog. Cytoreader tackles these issues using AI and digital technology.:

AI-assisted rapid review

AI-Assisted Rapid Review

Enables full-slide review in about 10 seconds. The underlying AI algorithm has been shown to reach a performance level comparable to experienced human readers, freeing valuable expert time.

AI-driven stain quality monitoring

AI-Driven Quality Monitoring

Provides on-slide AI controls that continuously assess staining performance and identify inconsistencies or artifacts early, ensuring reproducible and high-quality workflows.

Full digitalization of the dual-stain workflow

End-to-End Digitalization

Integrates dual-stain slides into a high-throughput digital workflow, including seamless connectivity with Hamamatsu whole slide scanners for ultimate scalability.

Core Platform Features

An Intuitive Platform Designed for the Modern Cytology Lab

Targeted Cell Review

Efficiently assess the 30 most relevant dual-stain events.

Rapid Keyboard Navigation

Streamline case review with intuitive shortcut keys.

AI-Guided Viewing

Utilize heatmaps to guide review of regions of interest.

Blinded Study Mode

Enable blinded analysis for training and quality assurance.

Collaborative Team Workflow

Facilitate tiered workflows for optimal QC.

Slide Workflow Management

Manage slide workflows, assign tasks, and monitor progress.

Targeted Cell Review Rapid Keyboard Navigation AI-Guided Viewing Blinded Study Mode Collaborative Team Workflow Slide Workflow Management

Implementation Models

A Solution That Scales With Your Laboratory

On-Premise Installation

For high-volume laboratories, Cytoreader is installed on-premise and fully integrated into your existing IT and digital pathology infrastructure.

  • Full integration with Hamamatsu scanners.
  • Compliance with local cybersecurity and data archival policies.
  • Proven 24/7 availability in routine clinical settings.

Scanning & Analysis Service

For a rapid start with no capital investment, leverage our full-service model. Simply send us your slides, and we provide the results.

  • No local IT infrastructure or scanner required.
  • Secure, web-based access to results and quality reports.
  • Transform your quality monitoring process in days.

References

Key publications supporting our work and technology.

1. Clinical Evaluation of Human Papillomavirus Screening With p16/Ki-67 Dual Stain Triage in a Large Organized Cervical Cancer Screening Program.

Wentzensen, N., Clarke, M., Bremer, R., et al. (2019).

JAMA Internal Medicine, 179(7), 881-889. [DOI]

2. Performance of p16/Ki-67 immunostaining to detect cervical cancer precursors in a colposcopy referral population.

Wentzensen, N., Schwartz, L., Zuna, R., et al. (2012).

Clinical Cancer Research, 18(15), 4154-4162. [DOI]

3. Multiple biopsies and detection of cervical cancer precursors at colposcopy.

Wentzensen, N., Walker, J., Gold, M., et al. (2015).

Journal of Clinical Oncology, 33(1), 83-89. [DOI]

4. The Improving Risk Informed HPV Screening (IRIS) Study: Design and Baseline Characteristics.

Gage, J., Raine-Bennett, T., Schiffman, M., et al. (2022).

Cancer Epidemiology, Biomarkers & Prevention, 31(2), 486-492. [DOI]

5. Recommendations for Use of p16/Ki67 Dual Stain for Management of Individuals Testing Positive for Human Papillomavirus.

Clarke, M., Wentzensen, N., Perkins, R., et al. (2024).

Journal of Lower Genital Tract Disease.

6. STRIDES - STudying Risk to Improve DisparitiES in Cervical Cancer in Mississippi - Design and baseline results of a Statewide Cohort Study.

Risley, C., Stewart, M., Geisinger, K., et al. (2021).

Preventive Medicine. [DOI]

7. Human papillomavirus genotyping, human papillomavirus mRNA expression, and p16/Ki-67 cytology to detect anal cancer precursors in HIV-infected MSM.

Wentzensen, N., Follansbee, S., Borgonovo, S., et al. (2012).

AIDS, 26(13), 2185-2192. [PMID]

8. Automated evaluation of p16/Ki-67 dual-stain cytology as a biomarker for detection of anal precancer in men who have sex with men and are living with human immunodeficiency virus.

Cohen, C., Wentzensen, N., Lahrmann, B., et al. (2022).

Clinical Infectious Diseases, 75(3), 1565-1572. [DOI]

9. Accuracy and Efficiency of Deep-Learning–Based Automation of Dual Stain Cytology in Cervical Cancer Screening.

Wentzensen N, Lahrmann B, Clarke MA, et al. (2020).

J Natl Cancer Inst, djaa066. [DOI]

10. Closing the Automation Gap: Robust AI for Dual-Stain Cervical Cancer Screening Triage.

Lahrmann B, Keil A, Miranda-Ruiz F, et al. (2025, March 3).

PREPRINT (Version 1) Research Square. [DOI]