Myriad Genetics Inc. (MYGN), a molecular diagnostics and precision medicine company, on Tuesday announced the launch of the Prolaris + AI test to facilitate prognosis prediction of prostate cancer.
Prostate cancer is a malignancy of the prostate gland in males. With over 300,000 new cases diagnosed annually in the U.S. alone, early treatment is often key to survival. The severity of the disease is measured using Gleason scores, which grade the extent of abnormality in tumor cells extracted in a biopsy.
The Prolaris-AI prostate cancer biomarker test combines clinical-pathological features, an independent molecular score, and AI-powered digital pathology technology. It builds on technology from PATHOMIQ AI, a digital AI platform company.
The test assesses if a patient is safe for active surveillance (AS), a monitoring protocol recommended for males who show a low or favorable intermediate risk for prostate cancer. It is the only test with AS metrics built on previously diagnosed, untreated patient cohorts.
Current pathology tools limit the guidance required for surveillance intensity, so the AI model predicts the likelihood of higher Gleason scores at a subsequent check-up. A Prolaris clinical cell-cycle risk (CCR) score is also provided to determine long-term prognostic risk.
Additionally, a validation study was conducted, with the AI model trained using biopsy histopathology images of 998 patients and validated in 296 patients. The AI-Gleason Upgrade Risk (AI-GUR) was proven to be a statistically significant predictor of Gleason score upgrade at follow-up biopsy, independent of clinical variables, supplementing the efficacy of the test.
The Prolaris-AI test is expected to be launched at the end of May 2026.
MYGN closed Tuesday at $3.85, up 0.79%. In the pre-market, shares are trading at $3.91, up 1.71%.
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