Myriad Genetics (NASDAQ: MYGN) announced the launch of its Prolaris + AI Test, which combines genomic analysis with artificial intelligence-powered digital pathology for prostate cancer assessment. The test will be available starting May 29, 2026, for samples processed in the United States except New York State.

The test integrates Myriad's existing Prolaris clinical cell-cycle risk score with PATHOMIQ AI technology to evaluate patients for active surveillance suitability. The AI component analyzes digital biopsy images to predict the likelihood of a higher Gleason score at the next biopsy.

According to the company's press release, a validation study examined 998 patients for AI model training and 296 patients for validation. The study focused on patients with diagnostic Gleason scores of 3+3 and 3+4 who were candidates for active surveillance. The AI-derived score demonstrated statistical significance in predicting Gleason upgrades at follow-up biopsies.

"Prostate cancer is projected to be the leading cancer diagnosis in the U.S. this year, with more than 300,000 patients newly diagnosed," said Brian Donnelly, Chief Commercial Officer at Myriad Genetics.

The test provides a single integrated report combining long-term prognostic information from the molecular score and near-term biopsy upgrade risk from the AI analysis. Active surveillance is recommended by clinical guidelines for men with low- and favorable intermediate-risk prostate cancer.

Approval for samples from New York State is expected to follow the initial launch. The test requires no additional tissue beyond what is used for the standard Prolaris Biopsy Test.