Breast cancer is a growing concern in the United States, with a significant number of cases occurring without a clear explanation. The majority of breast cancer cases are sporadic, meaning they result from environmental factors rather than inherited genetic mutations. This lack of identifiable causes is alarming as nearly 370,000 people are expected to be diagnosed with breast cancer this year alone. The American Cancer Society estimates that 42,000 women will die from the disease in 2025.
Prevention and early detection are crucial in improving survival rates, and both rely on understanding individual risk factors. Dr. Constance Lehman, a breast imaging specialist at Harvard Medical School, emphasizes the importance of accurately measuring risk, which can be challenging with current assessment methods.
Current risk assessment tools primarily focus on family history and genetic factors. Mammograms play a key role in detecting cancer and estimating future risk by assessing breast density. However, the interpretation of mammogram results can vary among radiologists, leading to inconsistent outcomes.
Ancillary risk assessment tools like the Tyrer-Cuzick and Gail models gather information from patient questionnaires to estimate the likelihood of developing breast cancer. However, these tools can be inaccurate, especially in racially and ethnically diverse populations, as they were originally trained on data that lacked representation from these groups.
To address the disparities in risk assessment, Dr. Lehman founded Clairity, Inc. and developed Clairity Breast, an FDA-authorized platform that uses AI to analyze mammograms and generate a five-year breast cancer risk score. Unlike traditional models, Clairity Breast assesses risk directly from the mammogram, eliminating the need for patient surveys. The platform’s data set was developed using images from a diverse patient population, ensuring more accurate risk assessment for all women.
Clairity Breast is not a diagnostic tool but a prognostic test that assesses the risk of future cancer based on subtle patterns detected by AI on the mammogram. Dr. Andrea Merrill, a breast surgeon, sees potential in Clairity’s approach, especially in detecting cancers that may go unnoticed with current imaging techniques.
Clairity Breast is set to launch in 2025 as a self-pay option, with plans to work with insurers for coverage. However, Merrill advises against delaying mammograms in anticipation of this tool, emphasizing the effectiveness of current screening methods in detecting breast cancer.
In conclusion, advancements in risk assessment tools like Clairity Breast offer promising opportunities to improve early detection and personalized care for breast cancer. However, it is essential to continue regular screenings and not rely solely on new technologies for timely diagnosis and treatment.