Ummon Healthtech™

p16/Ki67
AutoReader

1 in 2 p16/Ki67 dual-stain test analyses performed by a human operator results in false negatives(1)

Join the Future of Cervical Cancer Screening with p16/Ki67 AutoReader of Ummon. Benefit from faster, more accurate, and reliable results while improving patient care, optimizing workflows, and cementing your position as a leader in pathology.

Our p16/Ki67 AutoReader software leverages cutting-edge technology to automate the identification of double-labeled cells on p16/Ki67-stained, digitized smear images. This innovative solution is poised to transform cervical cancer screening, offering pathologists and pathology labs numerous scientific and professional benefits.

The issue

The p16/Ki67 dual-stain (DS) test is a highly reliable tool for cervical cancer screening, now integrated into the 2024 USCAP guidelines(2), which recommend its use for triaging HPV-positive results. This test reduces the need for colposcopies while enabling earlier detection of cervical intraepithelial neoplasia grade 3 or worse. Medico-economic studies have shown that the combined strategy of HPV testing and DS is the most cost-effective approach to screening, supporting the anticipated rise in DS test usage in the future(3).
1

The detection and interpretation of dual-stained cells are complex processes that can result in an incorrect diagnosis. 45,9% of p16/Ki67 test analyses performed by a human operator result in false negatives results(1).

2

Detection and interpretation are highly time consuming processes that require the involvment of a cytotechnologist and a pathologist. An average of 1 h of valuable and costly specialist time is required per slide.

Our Solution

The only CE-IVD certified p16/Ki67 test auto-reader

p16/Ki67 AutoReader harnesses advanced AI for precise analysis and annotation of p16/Ki67 dual-stained cervical cells.

p16/Ki67 AutoReader’s algorithms are refined through tens of thousands of cervical cell scans, ensuring unparalleled reliability and accuracy in results.

p16/Ki67 AutoReader has a user-friendly and efficient interface: Simply upload your scan files, start the analysis, and receive precise, suspicious cell identifications in record time.

p16/Ki67 AutoReader screenshot

Unparalleled Accuracy

Precise and reliable diagnosis contribute to superior patient care

Sensitivity

100%

vs 79% for human operators(4)

Negative Predictive Value

100%

vs 54% for human operators(4)

Speed saves live

3 minutes for a full scan and marking of a cervical cell slide(1) vs to 45 min. for a cytotechnologist

When dealing with cancer, every minute counts. Faster processing times allows diagnosing substantially more patients and starting their treatment earlier.

Benefits for pathology labs

Better

cancer care for patients

Higher

medical staff satisfaction

Improved

reputation and attractivity

Shielding

from legal risks

p16/Ki67 AutoReader in lab

Reduced detection and diagnostics time

Uninterrupted processing around the clock (24/7) leads to reduced diagnosis times, allowing more patients to be diagnosed more quickly.

Addressing Cytotechnologist Scarcity

This approach not only addresses the scarcity of cytotechnologists but also helps eliminate substantial related costs.

Enhancing Laboratory Profitability

Increased patient diagnoses and a reduced need for cytotechnologists contribute to heightened laboratory profitability.

Benefits of marketing p16/Ki67 AutoReader

For dual-stain test manufacturers

  • Adding value to their offering in a market that is set to become price-driven as of 2024, or
  • Providing an additional service that generates recurring revenue
  • Collected data contributes to improved product management and market intelligence

For cell scanner manufacturers

  • Commercial advantage vs competition by:
    • Bundling p16/Ki67 AutoReader with their scanners, for superior value at the same price point, or
    • Marketing p16/Ki67 AutoReader as an add-on, creating additional recurring revenue
  • Establishing exclusive and lasting client affiliations
  • Collected data contributes to improved product management and market intelligence

The Technology

Revolutionary Dual-Model Analysis

p16/Ki67 AutoReader features an innovative scoring system blending cutting-edge deep learning with classical machine learning, ensuring a balanced analysis of color and textural features for high-precision diagnostics.

Advanced Calibration for Consistency

Our unique calibration module overcomes inter-laboratory and interscanner variations. Using a color calibration process aligned with our extensive training set, we ensure consistent, accurate results, enhancing reliability.

Intuitive User Experience

p16/Ki67 AutoReader’s ergonomic design allows even first-time users to confidently manage the system, enabling quick and efficient analysis without compromising accuracy. Ideal for seamless integration into medical professionals’ diagnostic workflow.

p16/Ki67 AutoReader technology

(1) Source: based on the clinical study report for CE-IVD approval of p16/Ki67 AutoReader.
(2) Source: Recommendations for Use of p16/Ki67 Dual Stain for Management of Individuals Testing Positive for Human Papillomavirus
(3) Source: Medico-economic evaluation of cervical cancer screening in France
(4) Source: clinical study report for CE-IVD approval. Se>97% Sp>94% values considered as the lower bound of the 95% interval, based on the Wilson Score Interval.