The U.S. Food and Drug Administration (FDA) has granted approval for a groundbreaking artificial intelligence (AI) tool, Clairity Breast, developed by the Boston-based startup Clairity. This innovative tool aims to predict a patient’s five-year risk of developing breast cancer based on routine mammograms. With this authorization, Clairity is set to launch the risk assessment feature by the end of 2023.
A Shift in Breast Cancer Detection
Historically, AI has been employed to detect breast cancer after it develops, with the first computer-assisted detection system being approved in 1998. However, Clairity Breast takes a radically different approach. It doesn’t merely detect existing cancers but aims to predict future risk, a function that has previously been beyond the capabilities of traditional diagnostic methods. According to Connie Lehman, founder of Clairity and a diagnostic radiologist at Massachusetts General Hospital, this tool extracts subtle clues from mammograms that are undetectable to the human eye and brain.
“What we’re doing here is something that humans can’t do,” says Lehman. “It’s extracting subtle clues from a mammogram that the human eye can’t see and the human brain can’t process.”
Expanding Risk Detection Beyond Family History
Most current risk models for breast cancer focus on age and family history, but Lehman notes that 85% of women diagnosed with breast cancer have no family history of the disease. This highlights a major flaw in existing risk models, which can miss women who are truly at high risk but don’t fall into traditional risk categories.
The Clairity Breast tool was developed using Hologic’s 2D screening mammography system and will be integrated into patients’ routine mammogram screenings. This AI-powered risk prediction aims to expand breast cancer testing to more women—especially those who have previously been difficult to identify as high-risk candidates.
Addressing Diversity in Risk Prediction
One of the key challenges in breast cancer risk prediction has been the historical reliance on data predominantly from white women. Clairity took great care in developing its model to include a diverse range of patients, ensuring that the AI tool would be effective for women of different races and ethnicities. This broader representation will help ensure that Clairity Breast provides more accurate predictions across diverse populations.
Strategic Rollout and Industry Support
Clairity plans to roll out the Clairity Breast tool in select centers later this year, with plans for expansion over time. The company has made strategic leadership changes, appointing Jeffrey Luber as CEO in 2022, who previously led marketing efforts at Binx Health and Exact Sciences. Luber is expected to drive the expansion of the company’s market reach and ensure that Clairity Breast becomes a key player in the evolving landscape of breast cancer care.
In January 2023, Clairity received a $1 million investment from the Breast Cancer Research Foundation, further cementing the company’s position as an innovator in the field of early breast cancer detection and risk prediction.
The Future of Personalized Cancer Prevention
The introduction of Clairity Breast is poised to transform breast cancer prevention and early detection. By predicting future risk rather than waiting for cancer to develop, AI-powered risk assessments could become a cornerstone of precision medicine, allowing healthcare providers to offer more personalized care and improve outcomes for women at risk. This breakthrough tool has the potential to identify high-risk individuals earlier than ever before, leading to more proactive monitoring, preventative strategies, and ultimately, lives saved.
In conclusion, Clairity Breast represents a paradigm shift in how we approach breast cancer detection. By harnessing the power of AI, it aims to provide women with the tools they need to better understand and manage their breast cancer risk, leading to a future where early intervention and personalized care are the norm.
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