Major paradigm shift incorporates five-year risk assessment and identifies increased-risk women beginning at age 35
BOSTON, April 14, 2026 (GLOBE NEWSWIRE) — Clairity, Inc. announces the National Comprehensive Cancer Network® (NCCN®) has updated its 2026 NCCN Clinical Practice Guidelines in Oncology for Breast Cancer Screening and Diagnosis to include a new risk assessment option that uses artificial intelligence to analyze a woman’s mammogram and assess her future risk of developing breast cancer. Clairity Breast is the first FDA approved model to predict five-year breast cancer risk using AI-based mammography and is currently the only model available for commercial use.
This new approach expands the ability to identify women at increased risk, particularly those who would not be identified through traditional methods such as genetics or family history—creating new opportunities for more personalized detection and prevention.
The 2026 guidelines introduce a five-year breast cancer risk threshold (≥1.7%), informed by AI-based analysis of mammograms, as a criterion for identifying women at increased risk.
Specifically, the updated guidelines:
- Link risk assessment directly to clinical action, including recommendations for supplemental imaging and consideration of risk-reduction strategies
- Call for periodic reassessment of risk over time, recognizing that risk is not static
- Expand identification of increased-risk individuals starting at age 35, enabling earlier intervention
These updates support Clairity’s commitment to identify women at increased risk and support proactive, risk-informed approaches to care. This inclusion also reflects a broader shift toward more dynamic and individualized risk assessment in breast cancer screening and prevention.
“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,” said Connie Lehman, MD, PhD, Professor of Radiology, Harvard Medical School (on leave), Founder and CEO of Clairity, Inc. “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 five-year risk assessment at the point of care—helping make more precise, individualized risk-based care accessible to far more women.”
Advances in genetic testing have made it possible to identify women with inherited mutations, such as BRCA1 and BRCA2, who face significantly elevated risk. These advances have enabled more targeted screening and prevention strategies and have saved countless lives through earlier detection and prevention.
However, the majority of breast cancers occur in women without a known genetic mutation or significant family history, highlighting a critical gap in traditional risk assessment approaches. Until now, there has not been a scalable, clinically integrated way to identify risk in this broader population.
“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” said Robert Smith, PhD, Director, American Cancer Society Center for Early Cancer Detection. “Most women diagnosed with breast cancer have no known genetic mutation or strong family history, and although breast density is common, 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.”
Recent advances in AI have enabled new approaches to analyzing mammograms to assess future breast cancer risk. These capabilities are now reaching clinical practice, supported by FDA’s creation of a new regulatory category for imaging-based AI models designed to assess five-year future breast cancer risk.
“It’s encouraging to see advances in breast cancer risk assessment beginning to reach clinical care, including AI-based approaches that may help identify higher-risk women earlier—particularly those under 50 who might otherwise go unflagged,” said Dr. Judy Garber, Breast Cancer Research Foundation Scientific Director. “While continued research and real-world evaluation are essential, these tools represent a meaningful step toward more personalized screening and prevention. The inclusion of AI-informed risk assessment in NCCN guidelines supports BCRF’s growing confidence in this approach and underscores the impact that sustained research investment can have on improving care.”
“This is a meaningful evolution in how we think about breast cancer risk,” said Beth Mittendorf, MD, PhD, Chief, Breast Surgery, Beth Israel Deaconess Medical Center and Professor of Surgery, Harvard Medical School. “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.”
“This provides an opportunity to translate these advances into clinical practice in a way that ensures women truly benefit,” said Tari King, MD, Chief of Breast Surgery, Emory University School of Medicine and Surgical Director, Glenn Family Breast Center Winship Cancer Institute. “That means making risk assessment accessible, understandable, and actionable across care settings so that more women can receive care tailored to their individual risk.”
The new framework could influence clinical practice, payer policy, and health system strategies by supporting earlier identification of women who may benefit from enhanced screening or preventive interventions if validated in future studies.
This update reflects a broader momentum across the field toward precision prevention—using data-driven insights to tailor screening and reduce the burden of advanced disease.
About Clairity
Clairity is a medical technology company focused on advancing cancer risk assessment through artificial intelligence and computer vision. Clairity’s platform can uncover subtle patterns in routine mammogram images that are invisible to the human eye, helping clinicians and their patients to better understand future cancer risk and support more personalized prevention strategies. Clairity’s mission is to shift the standard of care from late-stage treatment to proactive risk-informed prevention. To learn more, visit www.clairity.com.
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As with all elements of the NCCN Guidelines, NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
