Myriad Genetics announced the launch of the Prolaris Plus AI Test at the end of this month. Prolaris will be the first and only prostate cancer biomarker test to unite clinical-pathological features, an independent molecular score, and independent AI-powered digital pathology technology. This combination helps identify if a patient is safe for active surveillance and how refinement of active surveillance intensity can be personalized.

This new paradigm in patient care builds upon technology from PATHOMIQ AI, a digital pathology AI platform company. The Prolaris Plus AI test is the only test where active surveillance metrics on patient results were built on studies with previously diagnosed, untreated patient cohorts. The Prolaris Plus AI test will continue to help doctors identify patients who are safe for single-modal treatment.

Active surveillance is recommended by major clinical guidelines for men with low- and favorable intermediate-risk prostate cancer, but follow-up can vary widely by the limited ability of traditional clinical and pathology tools to predict short-term tumor behavior to help guide surveillance intensity. The Prolaris Plus AI Test was developed to address this gap by providing the likelihood of a higher Gleason score at next biopsy to help clinicians tailor active surveillance protocols. The Prolaris Biopsy Test has already outperformed other biomarker tests in identifying appropriate patients for active surveillance in low and intermediate-risk populations.

Without requiring additional tissue, the enhanced Prolaris Plus AI Test provides a single, integrated report that combines long-term prognostic risks from the Prolaris clinical cell-cycle risk score and near-term likelihood of a higher Gleason score at the next biopsy, based on a PATHOMIQ AI-derived score. Together, these complementary insights help clinicians confirm active surveillance suitability and personalize surveillance intensity with greater confidence. Prostate cancer is biologically diverse, even within the same tumor.

AI-powered digital pathology detects morphometric patterns indicative of cancer aggressiveness in biopsy tissue that is not possible with traditional pathology. In a recent validation study, an AI model was trained and developed on the prostate biopsy histopathology digital image features of 998 patients and validated in a cohort of 296 patients. All patients were candidates for active surveillance by both guidelines and Prolaris criteria with diagnostic Gleason scores of 3+3 and 3+4. The validation study demonstrated that the AI-GUR (Artificial Intelligence-Gleason Upgrade Risk) is a statistically significant predictor of Gleason upgrade at first follow-up biopsy, independent of time elapsed since diagnosis and other clinical variables.

Notably, AI-GUR provides information not captured by conventional risk stratification tools or cribriform morphology, underscoring its unique value. The predictive power of AI-GUR is robust across biopsy intervals, suggesting it may capture both disease progression and mischaracterization of the initial biopsy. The new AI metric will be available for all Prolaris Biopsy Tests performed on samples in the U.S. (other than from New York State) starting with tests processed on May 29, 2026.

Approval for samples from New York State is expected to come soon.