Clairity Breast Is Added to NCCN Guidelines for Breast Cancer Screening and Diagnosis

The National Comprehensive Cancer Network (NCCN) has updated its 2026 Clinical Practice Guidelines in oncology for breast cancer screening and diagnosis to include Clairity Breast, an artificial intelligence (AI)–based risk assessment tool that analyzes mammograms and assesses patients’ future risk for breast cancer development.^1,2

The updated NCCN Guidelines have debuted a 5-year AI mammogram analysis–based breast cancer risk threshold of at least 1.7% as one of the criteria for identifying patients at higher risk. The Guidelines also recommend direct clinical actions to take following the identification of higher-risk individuals, such as supplemental imaging and risk-reduction strategies; advocate periodic risk assessment over time; and expand the population of people who can be identified at increased risk to begin at 35 years of age.

“This is a meaningful evolution in how we think about breast cancer risk,” Beth Mittendorf, MD, PhD, chief of Breast Surgery at Beth Israel Deaconess Medical Center and professor of surgery at Harvard Medical School in Boston, Massachusetts, stated in a news release.¹ “Incorporating this approach into national guidelines expands our ability to identify women who may otherwise not be recognized as being at increased risk, creating new opportunities for more personalized screening and prevention strategies.”

Clairity Breast was granted de novo authorization by the FDA in June 2025 for use in predicting future 5-year breast cancer risk.³ It is the first FDA-approved and commercially available risk tool to predict the 5-year risk of breast cancer using AI-based mammography.¹ Patients are eligible for Clairity Breast screening analysis if they do not have a known breast cancer when they present for their screening mammogram.⁴

“For decades, we’ve known that the mammogram contains critical information—not just about the presence of cancer, but about a woman’s future risk,” Connie Lehman, MD, PhD, a professor of radiology at Harvard Medical School, as well as the founder and chief executive officer of Clairity—the developer of Clairity Breast—added in the news release.¹ “Advances in AI now allow us to extract that information in a clinically meaningful way. This is the foundation on which we developed Clairity Breast—the FDA-authorized, imaging-based AI model that provides 5-year risk assessment at the point of care—helping make more precise, individualized risk-based care accessible to far more women.”

How does Clairity Breast work?

This platform uses AI to analyze pixel-level imaging subtleties on routine bilateral screening mammograms and identify which results correspond with future risk of developing breast cancer.^3,4 This process results in a 5-year risk score and a percentage that represents the probability of an individual receiving a breast cancer diagnosis or developing breast cancer within 5 years following the screening mammogram. These results are sent to health care providers through existing communication methods, allowing for the execution of more personalized follow-up clinical decisions.³

“We have long relied on family history, genetic testing, and breast density to assess breast cancer risk, but these approaches fail to identify many women at higher risk,” Robert Smith, PhD, director of the American Cancer Society Center for Early Cancer Detection, added in the news release.¹ “Most women diagnosed with breast cancer have no known genetic mutation or strong family history, and although breast density is common, [it] is too broad a measure to meaningfully stratify individual risk. This situation highlights a fundamental gap in our current approach, where AI-based analysis of mammograms represents an important new direction to overcome these limitations, and hopefully move toward more precise and individualized risk assessment.”

How was Clairity Breast developed?

This model was trained on millions of images and was also validated using approximately 77,000 mammograms across 5 screening centers that were geographically distinct from each other, including both free-standing and hospital-based institutions.³ This allowed the platform to be tested in a diverse patient population. The model was validated through 5-year patient outcome data.

“[The updated NCCN Guidelines] provide an opportunity to translate these advances into clinical practice in a way that ensures women truly benefit,” Tari King, MD, chief of Breast Surgery at Emory University School of Medicine and surgical director of the Glenn Family Breast Center at Winship Cancer Institute in Atlanta, Georgia, concluded in the news release.¹ “That means making risk assessment accessible, understandable, and actionable across care settings so that more women can receive care tailored to their individual risk.”

References

1. Clairity announces update to NCCN guidelines to include AI mammogram-based risk tool to identify future breast cancer risk in women missed by traditional methods. News release. Clairity. April 14, 2026. Accessed April 14, 2026. https://www.globenewswire.com/news-release/2026/04/14/3273278/0/en/Clairity-Announces-Update-to-NCCN-Guidelines-to-Include-AI-Mammogram-Based-Risk-Tool-to-Identify-Future-Breast-Cancer-Risk-in-Women-Missed-by-Traditional-Methods.html
2. NCCN. Clinical Practice Guidelines in Oncology. Breast cancer screening and diagnosis, version 1.2026. Accessed April 14, 2026. https://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf
3. Clairity becomes the first FDA-authorized AI platform for breast cancer prediction – historic milestone for women’s health. News release. Clairity. June 2, 2025. Accessed April 14, 2026. https://www.businesswire.com/news/home/20250602896762/en/ADDING-MULTIMEDIA-Clairity-Becomes-the-First-FDA-Authorized-AI-Platform-for-Breast-Cancer-Prediction-Historic-Milestone-for-Womens-Health
4. A novel platform for prediction. Clairity. Accessed April 14, 2026. https://clairity.com/healthcare-providers/