Myriad Genetics to Launch Prolaris + AI Test May 29 with AI-GUR Validation
MYGN•Myriad Genetics will launch Prolaris + AI at month-end, the first prostate cancer test combining its cell-cycle risk score with AI-powered digital pathology to refine active surveillance. Validation study of 998 training and 296 validation patients found AI-GUR predicts Gleason upgrades, and U.S. availability begins May 29, excluding New York.
1. Launch of Prolaris + AI Test
At the end of May 2026, Myriad Genetics will introduce Prolaris + AI, the first prostate cancer biomarker test integrating its cell-cycle risk score with AI-driven digital pathology from PATHOMIQ. The unified report enables clinicians to assess long-term prognosis and near-term upgrade risk in a single analysis.
2. Validation Study Demonstrates AI-GUR Efficacy
A study training on 998 patient biopsies and validating on 296 patients with Gleason scores 3+3 and 3+4 showed that the AI-GUR metric independently predicts Gleason upgrades at first follow-up biopsy, outperforming conventional risk stratification.
3. Market Potential and Clinical Guidelines
Prostate cancer is projected to be the leading U.S. cancer diagnosis in 2026 with over 300,000 new cases, and active surveillance is endorsed for low to favorable intermediate risk. Prolaris + AI addresses gaps in traditional tools by refining surveillance intensity and enhancing patient management.
4. Availability and Geographic Scope
The AI metric will be included in all U.S. Prolaris Biopsy tests processed from May 29, 2026, excluding New York State. Approval for New York samples is expected soon, expanding nationwide access.
