The test combines genomic risk assessment and digital pathology analysis to help clinicians tailor monitoring strategies.
Myriad Genetics announced the launch of Prolaris + AI, a prostate cancer biomarker test that combines clinical-pathological features, an independent molecular score, and digital pathology artificial intelligence (AI).
The test is designed to help clinicians determine if a patient is safe for active surveillance and how to personalize the intensity of that surveillance. According to a press release from Myriad Genetics, the Prolaris + AI test is the only biomarker test where active surveillance metrics were developed using studies with previously diagnosed, untreated patient cohorts. The technology builds upon a digital pathology AI platform from PATHOMIQ AI.
“Prostate cancer is projected to be the leading cancer diagnosis in the US this year, with more than 300,000 patients newly diagnosed. The Prolaris + AI Test introduces a valuable tool to use for active surveillance planning,” says Brian Donnelly, chief commercial officer, Myriad Genetics, in a release. “The combination of Prolaris with AI marks meaningful progress in prostate cancer management for both patients and providers.”
Integrating Genomic and Pathology Data
The integrated report combines long-term prognostic risks from the Prolaris clinical cell-cycle risk (CCR) score with the near-term likelihood of a higher Gleason score at the next biopsy. This near-term likelihood is based on a score derived from PATHOMIQ AI.
AI-powered digital pathology is used to detect morphometric patterns in biopsy tissue that indicate cancer aggressiveness, which may not be visible through traditional pathology. These insights are intended to help clinicians confirm active surveillance suitability and personalize surveillance protocols without requiring additional tissue.
Validation Study Results
In a validation study involving 296 patients, the Artificial Intelligence-Gleason Upgrade Risk (AI-GUR) was found to be a statistically significant predictor of Gleason upgrade at the first follow-up biopsy. The study included patients who were candidates for active surveillance with diagnostic Gleason scores of 3+3 and 3+4.
The predictive power of the AI-GUR remained robust across different biopsy intervals, according to the study. This suggests the metric may capture both disease progression and potential mischaracterization of the initial biopsy. Notably, the AI-GUR provides data not captured by conventional risk stratification tools or cribriform morphology.
The new AI metric will be available for Prolaris biopsy tests performed on samples in the US, excluding New York State, starting May 29, 2026. Approval for samples from New York State is expected soon.
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