Starting Thursday, women across the United States will have access to a new artificial intelligence (AI) tool that estimates their risk of developing breast cancer within five years based on a single recent mammogram. The tool, known as Clarity Breast, was developed by Everlywell, a digital health company, and received approval from the Food and Drug Administration (FDA) last year. Previously offered only in select locations in Massachusetts and Colorado, Clarity Breast is now available nationwide for $249, though it is not covered by insurance.
Unlike conventional mammogram analysis, which focuses on detecting existing cancer, Clarity Breast analyzes imaging to identify subtle patterns linked to future cancer risk, even when scans appear normal to radiologists. The AI generates a probability score from zero to 100 that categorizes patients as having average, intermediate elevated, or high risk of developing breast cancer within the next five years. Scores below 1.7 percent indicate average risk, between 1.7 and 3 percent indicate intermediate risk, and above 3 percent indicate high risk.
Healthcare professionals emphasize that the AI score should be used alongside other clinical data, including family and personal medical history, to inform screening and preventive care decisions. Dr. Eleonora Teplinsky, head of breast and gynecologic medical oncology at Valley Health System in New Jersey, said the technology has the potential to be “practice-changing,” particularly as younger women are increasingly diagnosed with breast cancer—often before the standard screening age of 40—and without strong family history indicators.
Dr. Connie Lehman, founder and CEO of Clarity, noted that the majority of breast cancers occur in women without an obvious family history, making risk prediction tools particularly valuable for identifying those who might otherwise “fall through the cracks.” The test is available to individuals who have had a recent standard mammogram within the past 12 months, although women undergoing cancer treatment or carrying known high-risk genetic mutations are not eligible.
Despite the promise, some experts caution about potential limitations. The AI model assesses risk rather than detecting existing cancer, so a low-risk score cannot guarantee that breast cancer will not develop, and a high score does not mean cancer is present. There is concern, expressed by Dr. Debra Monticciolo, chair of the American College of Radiology’s breast cancer screening committee, that women with low scores might become falsely reassured and delay future screening.
Everlywell will obtain mammogram images directly from participating imaging centers, upload them to Clarity’s platform, and provide patients with a digital risk report accessible via their website. The availability of AI-driven risk assessments as early as age 35 could influence guidelines and encourage earlier screening for some women. However, medical professionals recommend careful interpretation of results within a broader clinical context to balance benefits against the risk of unnecessary anxiety or intervention.