RadNet, Inc., the largest provider of outpatient diagnostic imaging services, and its wholly owned subsidiary, DeepHealth, a global leader in AI-powered health informatics, announced results from the largest real-world analysis of AI-driven breast cancer screening ever conducted in the United States. Published in Nature Health, the findings support the clinical effectiveness and benefit of DeepHealth’s AI technology to deliver equitable results across several racial, ethnic and breast density patient groups.
The AI-Supported Safeguard Review Evaluation (ASSURE) study examined the AI-powered workflow that is at the heart of RadNet’s Enhanced Breast Cancer Detection™ (EBCD™) program. This study included mammograms from over 579,000 women across 109 community-based imaging sites in California, Delaware, Maryland and New York. The research compared state-of-the-art 3D mammography screening to a novel AI-driven protocol that combines DeepHealth’s FDA-cleared computer-aided detection and diagnosis (CADe/x) software with an AI-supported Safeguard Review workflow, which can trigger a second breast imaging expert review of high-suspicion cases—a workflow that RadNet now offers as EBCD™.
“Beyond the remarkable results, what sets this research apart is its scale, diversity and real-world applicability,” said Dr. Howard Berger, President and Chief Executive Officer of RadNet. “There has never been a similar study of this size in the United States, much less one with such a diverse patient population, that examines the patient impact and efficacy of AI-assisted breast cancer screening.”
The ASSURE study demonstrated that the AI-powered workflow led to a 21.6 per cent increase in cancer detection rate compared to state-of-the-art 3D mammography screening, while maintaining recall rates within American College of Radiology guidelines and increasing positive predictive value by 15 per cent. This workflow is enabled by the applications that make up DeepHealth’s Breast Suite offering. Together, they deliver these benefits across patient populations, including the more than 150,000 Black women enrolled. Black women face 40 per cent higher breast cancer mortality in the United States. Furthermore, the ASSURE study showed that the workflow underlying RadNet’s EBCD™ program delivered a 22.7 per cent boost in cancer detection rate compared to 3D mammography screening for women with dense breasts, who experience both increased cancer risk and diagnostic challenges.
