First Patient Receives AI-Based Breast Cancer Risk Score
The first clinical patient has received the Clairity Breast score — the first FDA-authorized artificial intelligence platform capable of predicting future breast cancer risk over five years using only an existing screening mammogram. The historic milestone took place at Beth Israel Deaconess Medical Center (BIDMC) in Chestnut Hill Square, Boston, marking a new era in personalized breast cancer risk assessment.
What Is Clairity Breast?
Clairity Breast is the first AI model authorized by the FDA through the De Novo pathway — a regulatory classification reserved for genuinely innovative medical technologies with no predicate device. Unlike other AI tools in mammography that assist in detecting existing lesions, Clairity goes further: it predicts the likelihood that a woman will develop breast cancer over the next five years, even when the current mammogram is normal.
The model was trained on approximately 421,499 mammograms and externally validated on more than 120,000 exams, demonstrating consistent performance across different ages, races, and breast densities. This extensive and diverse validation is crucial, as traditional risk assessment models like Gail and Tyrer-Cuzick rely on risk factor questionnaires that frequently underestimate risk in minority populations.
How It Works in Clinical Practice
The workflow is remarkably simple: the score can be ordered by the patient’s physician or requested by the patient herself upon arriving for her routine screening mammogram. Clairity automatically analyzes the mammographic images and generates a risk score that can be reviewed with the patient’s provider, with the option of referral to a breast health specialist at BIDMC’s Breast Care Center.
For radiology departments worldwide, where mammography screening already saves lives even in advanced stages, adding an AI-based predictive component could transform screening programs. Instead of treating all women with the same protocol, centers could stratify patients by risk and personalize screening frequency and modality.
Scientific Validation and Differentiators
What makes Clairity particularly relevant is its ability to detect subtle patterns in mammographic images that are invisible to the human eye — including variations in parenchymal texture, density distribution, and micro-vascular patterns that may indicate a breast microenvironment conducive to tumor development. This goes far beyond the ACR BI-RADS breast density classification, which is a coarse and highly subjective measure of risk.
The De Novo FDA authorization signals that the regulatory agency recognizes this as an entirely new category of medical device. Unlike the various AI tools approved for detection and triage, Clairity operates in primary prevention by identifying women who could benefit from more intensive screening or prophylactic interventions before any lesion is visible.
Implications for Breast Screening Programs
In healthcare systems where access to mammography is still unequal and resources are limited, a tool like Clairity could significantly optimize screening programs. Risk stratification would allow directing intensive resources — such as supplemental breast MRI or semi-annual screening — to women with the highest likelihood of developing cancer, while low-risk women could safely follow standard protocols.
The regulatory precedent set by the FDA paves the way for discussions about incorporating predictive AI into breast screening protocols worldwide. The transition from reactive radiology to a predictive, personalized approach may be the next great leap in breast health.
Source: GlobeNewsWire / Clairity