Assessment of the efficacy and accuracy of cervical cytology screening with the Hologic Genius Digital Diagnostics System
Abstract
Background
Medical technologies powered by artificial intelligence are quickly transforming into practical solutions by rapidly leveraging massive amounts of data processed via deep learning algorithms. There is a necessity to validate these innovative tools when integrated into clinical practice.
Methods
This study evaluated the performance of the Hologic Genius Digital Diagnostics System (HGDDS) with a cohort of 890 previously reviewed and diagnosed ThinPrep Papanicolaou (Pap) tests with the intent to deploy this system for routine clinical use. The study included all diagnostic categories of The Bethesda System, with follow‐up tissue sampling performed within 6 months of abnormal Pap test results to serve as the ground truth.
Results
The HGDDS demonstrated excellent performance in detecting significant Pap test findings, with close to 100% sensitivity (98.2%–100%) for cases classified as atypical squamous cells of undetermined significance and above within a 95% confidence interval and a high negative predictive value (92.4%–100%).
Conclusions
The HGDDS streamlined workflow, reduced manual workload, and functioned as a stand‐alone system.