NCCN updates breast cancer screening guidelines

The National Comprehensive Cancer Network has updated its 2026 breast cancer screening and diagnosis guidelines to include AI-based mammogram analysis for five-year breast cancer risk assessment, according to Clairity.

Updated guidance introduces a five-year breast cancer risk threshold of 1.7% or higher, informed by AI-based mammogram analysis, as a criterion for identifying women at increased risk.

Clairity said the additions link risk assessment to clinical actions, including supplemental imaging and consideration of risk-reduction strategies. The update also calls for periodic reassessment and expands increased-risk identification starting at age 35.

Clairity Breast is the company’s AI-based mammography risk assessment platform. Clairity describes it as the first FDA-authorized AI platform that predicts a woman’s five-year future risk of developing breast cancer using an existing screening mammogram.

FDA granted De Novo authorization to Clairity Allix5 on May 30, 2025. The device is intended to generate a five-year breast cancer risk prediction based on a bilateral screening mammogram.

Eligible patients do not have known breast cancer at presentation for screening mammography, according to FDA documentation. The software is not intended to diagnose or detect breast cancer, provide care recommendations, replace clinical decision-making, or be used before radiologist interpretation is complete.

BCRF also noted that the NCCN update uses the 1.7% five-year risk threshold as a trigger for action and calls for ongoing reassessment over time.