Am J Clin Pathol. 2026 Jul 6;166(1):aqag081. doi: 10.1093/ajcp/aqag081.
ABSTRACT
OBJECTIVES: We sought to assess the real-world impact of the Genius Digital Diagnostics System (Genius Dx [Hologic, Inc]) on workload, efficiency, and turnaround time in a high-volume cervical cytology laboratory.
METHODS: The laboratory information system was retrospectively queried for all Papanicolaou test cases performed between January 1, 2023, and March 31, 2025. A total of 512 177 cases (655 468 reviews) were included. Genius Dx was implemented on August 1, 2024, and cases were classified as preimplementation or postimplementation. Daily caseload, number of reviewers, number of cases per reviewer, and accession-to-sign-out times were compared using independent-samples t tests. Diagnostic distributions were compared using ꭓ2 tests.
RESULTS: Average daily cytologist (CT) reviews were similar before and after Genius Dx (747.8 vs 758.4 cases) but required fewer CTs per day (10.4 vs 8.1; P < .001), increasing cases per CT per day from 74.5 to 94.7 (P < .001). Pathologist reviews per day increased (106.0 vs 145.3; P < .001) with fewer pathologists (4.4 vs 3.4; P < .001). Average daily CT case workload increased by 53.5% after implementation. Accession-to-sign-out times decreased for all diagnoses (P < .001). A small but statistically significant shift in diagnostic proportions was observed, with a decrease in negative results and an increase in atypical squamous cells of uncertain significance or higher (ASC-US+) findings with negligible effect size.
CONCLUSIONS: Implementation of Genius Dx substantially increased reviewer efficiency and reduced turnaround times without compromising diagnostic performance. The increased detection of ASC-US+ findings observed in this study are in line with results from the Genius Dx clinical trial and other published literature.
PMID:42480093 | DOI:10.1093/ajcp/aqag081
