FDA Clears First AI Tool for Breast Cancer Risk Prediction

In a groundbreaking development for breast cancer screening, the U.S. Food and Drug Administration (FDA) has granted de novo clearance to Clairity Breast, the first artificial intelligence (AI) tool designed to predict five-year breast cancer risk from routine mammograms. This clearance marks a significant shift in breast cancer risk assessment, moving beyond traditional methods that rely on factors such as age and family history.

Revolutionary Approach to Risk Assessment

Clairity Breast, developed by Boston-based startup Clairity, analyzes subtle imaging features in screening mammograms to identify patterns correlated with future breast cancer risk. Unlike existing AI tools that focus on detecting present cancer, Clairity Breast aims to predict future risk, potentially expanding early detection and prevention strategies.

Dr. Connie Lehman, founder of Clairity and a professor of radiology at Harvard Medical School, emphasized the novelty of this approach: "For more than 60 years, mammograms have saved lives by detecting early-stage cancers. Now, advancements in AI and computer vision can uncover hidden clues in the mammograms—invisible to the human eye—to help predict future risk."

The AI model behind Clairity Breast was trained on millions of images and validated across more than 77,000 mammograms from five geographically distinct screening centers. This diverse dataset is crucial, as it addresses historical biases in breast cancer risk prediction models, which were often built on data from predominantly white women.

Clinical Impact and Integration

Clairity Breast is designed to integrate seamlessly into existing clinical infrastructures, delivering a validated five-year risk score to healthcare providers. This integration aims to support more personalized follow-up care and precision prevention strategies.

Jeff Luber, CEO of Clairity, highlighted the potential impact: "What makes the availability of Clairity Breast a true sea change is that we're now predicting risk of future cancer from patterns in breast tissue, in an otherwise normal screening, before it's even there."

The tool's ability to identify women at higher risk could lead to more targeted use of supplemental screening methods, such as MRI. Robert A. Smith, Ph.D., senior vice president of early cancer detection science at the American Cancer Society, noted, "By integrating AI models that assess individual risk, we can better identify women at higher risk, and those who may benefit from supplemental screening methods, such as MRI, improving early detection and more effective prevention strategies."

Market Launch and Future Prospects

Following the FDA clearance, Clairity plans to launch the risk prediction platform with leading health systems through 2025. The company will begin with select centers before expanding access later this year.

Clairity has garnered significant financial support, including backing from Santé Ventures and ACE Global Equity. In January, the startup received a $1 million investment from the Breast Cancer Research Foundation, underscoring the potential impact of this technology on breast cancer research and prevention.

As the first AI tool cleared by the FDA for predicting five-year breast cancer risk from mammograms, Clairity Breast represents a significant advancement in personalized breast cancer screening and risk assessment. Its integration into clinical practice could potentially lead to earlier interventions, reduced late-stage diagnoses, and ultimately, improved patient outcomes in breast cancer care.