SALT LAKE CITY, May 26, 2026
Myriad Genetics announced the launch of Prolaris® + AI, the first prostate cancer test to combine genomics, clinical-pathological features, and AI-powered digital pathology into a single integrated diagnostic platform. Developed in collaboration with PATHOMIQ AI, the new test is designed to improve decision-making for men undergoing active surveillance (AS) for low- and favorable intermediate-risk prostate cancer, helping physicians personalize monitoring intensity and reduce uncertainty around disease progression.
The launch positions Myriad Genetics at the forefront of the growing intersection between precision oncology and artificial intelligence, introducing a next-generation diagnostic approach aimed at improving prostate cancer management through enhanced risk stratification.
Prolaris + AI Combines Genomics and Digital Pathology
The new Prolaris + AI Test integrates three independent sources of information into a single report: clinical-pathological features, the established Prolaris Clinical Cell-Cycle Risk (CCR) score, and a new AI-powered pathology metric derived from digital biopsy image analysis. The combined platform is designed to predict the likelihood of a future Gleason score upgrade during active surveillance, helping clinicians determine which patients are suitable for lower-intensity monitoring and which may require closer follow-up.
According to Myriad Genetics, the enhanced test does not require additional tissue samples and builds on the proven clinical utility of the original Prolaris Biopsy Test, which has previously demonstrated strong performance in identifying patients appropriate for active surveillance. The addition of AI aims to address one of the largest unmet needs in prostate cancer management: accurately predicting short-term tumor behavior in patients initially diagnosed with low-risk disease.
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The company stated that the new AI-enhanced metric will become available for all Prolaris Biopsy Tests processed in the United States beginning May 29, 2026, excluding New York State pending additional regulatory approval.
AI Model Demonstrates Strong Predictive Performance
The digital pathology component of the test is based on PATHOMIQ AI’s Artificial Intelligence-Gleason Upgrade Risk (AI-GUR) model, which analyzes morphometric patterns in biopsy tissue that may not be detectable using traditional pathology methods. Prostate cancer is highly heterogeneous, and tumor aggressiveness can vary significantly even within the same lesion, creating challenges for conventional diagnostic assessment.
In a recently completed validation study, researchers trained the AI model using biopsy histopathology image data from 998 patients and validated the system in an independent cohort of 296 patients. All patients were considered eligible for active surveillance based on current clinical guidelines and had diagnostic Gleason scores of 3+3 or 3+4.
The study demonstrated that AI-GUR was a statistically significant independent predictor of Gleason score upgrading at the first follow-up biopsy, regardless of the time elapsed since diagnosis or other clinical variables. Investigators reported that the AI model captured risk information not identified by conventional stratification tools or cribriform morphology analysis, highlighting its potential value in identifying hidden tumor aggressiveness and biopsy sampling limitations.
Researchers also found that the predictive performance of AI-GUR remained consistent across varying biopsy intervals, suggesting the technology may detect both early disease progression and under-characterized tumors at diagnosis.
Precision Oncology and AI Continue to Converge
The launch of Prolaris + AI reflects the broader industry trend toward integrating artificial intelligence, molecular diagnostics, and digital pathology into precision cancer care workflows. Active surveillance is increasingly recommended by major clinical guidelines for men with low-risk prostate cancer, but monitoring approaches vary widely because clinicians often lack accurate tools to predict near-term disease changes.
By combining genomic risk scoring with AI-driven pathology analysis, Myriad Genetics aims to provide clinicians with more personalized and data-driven surveillance strategies while potentially reducing overtreatment and unnecessary interventions.
With prostate cancer projected to become the most commonly diagnosed cancer in the United States this year, affecting more than 300,000 newly diagnosed patients, the company believes Prolaris + AI could play a major role in advancing individualized prostate cancer management and supporting precision oncology adoption across urology practices.
Source: Myriad Genetics press release
