'Revolutionary' AI risk assessment tool earns FDA's Breakthrough Device designation
The U.S. Food and Drug Administration has granted an artificial intelligence-enabled risk assessment technology its Breakthrough Device designation.
Called Prognosia Breast, the tool was developed by experts at Washington University School of Medicine in St. Louis. It predicts a woman’s five-year risk of developing breast cancer based on findings from their mammogram. Prognosia Breast provides a risk assessment score that can be compared alongside what is considered an average risk score based on U.S. national risk reduction guidelines. This enables women and their providers to make informed decisions about supplemental imaging, genetic testing and other diagnostics.
The tool is the product of a collaboration between Graham A. Colditz, MD, DrPH, the Niess-Gain Professor of Surgery at WashU Medicine and associate director of prevention and control at Siteman Cancer Center, and Shu (Joy) Jiang, PhD, an associate professor of surgery in the Division of Public Health Sciences in the Department of Surgery at WashU Medicine.
“We’re excited about the potential of this technology to improve risk prediction and prevention of breast cancer broadly, no matter where a woman is getting screened,” Colditz said in a statement. “The long-term goal is to make this technology available to any woman having a screening mammogram anywhere in the world. No matter the type of imaging they receive, our data show the software’s potential to identify women at increased risk of developing breast cancer over the next five years, providing them with opportunities to take targeted steps to reduce that risk.”
The machine learning system, which was trained on tens of thousands of mammograms of women who went on to develop cancer, combines imaging and a woman’s age to make its predictions. In clinical testing, it proved to be 2.2 times more accurate at predicting risk compared to current standards that use medical and family history to assess risk.
“Despite the sophistication of today’s breast imaging and its broad use for identifying existing tumors, today’s risk prediction for breast cancer is still questionnaire-based and not very good at estimating future risk,” Jiang said. “Our work has focused on filling that need for better methods. Moving to image-based risk prediction—which our studies have shown is much more accurate—has the potential to be revolutionary for patient care.”
Prognosia Breast can be utilized in both standard 2D images and 3D digital breast tomosynthesis exams. Currently, its Breakthrough Device designation applies to its assessment of mammograms acquired at a single time point. However, in the future, the team plans to incorporate longitudinal data to further refine its capabilities.
The Breakthrough Device designation is intended to expedite the path to approval. It is reserved for products that have shown promise to improve the diagnosis and treatment of serious and life-threatening diseases.
Learn more about the device here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.