#South Korea #Seoul #Lunit #Breast Cancer #AI Diagnostics

Lunit's Innovative Step Towards Breast Cancer Detection

Lunit, a pioneering firm in the field of AI for cancer diagnostics, recently reached a significant regulatory milestone by submitting a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its groundbreaking model, Lunit INSIGHT Risk. This advanced technology is designed to directly estimate a woman's five-year breast cancer risk using findings from routine screening mammograms, including both digital and synthetic versions.

The system developed by Lunit is particularly beneficial as it does not require patient questionnaires, providing a streamlined approach to risk assessment. Its foundation is rooted in pivotal research carried out at the Washington University School of Medicine in St. Louis, spearheaded by distinguished experts Dr. Graham Colditz and Dr. Shu (Joy) Jiang. What sets Lunit INSIGHT Risk apart is that it’s the first AI solution able to generate SEER-calibrated five-year absolute risk estimates specifically for U.S. women. For instance, a calculated 5% risk implies that out of 100 women sharing similar risk profiles, five are expected to develop breast cancer within the next five years.

The efficacy of this model has been demonstrated in two peer-reviewed studies, which were prominently published in reputable journals, JAMA Network Open and JCO Clinical Cancer Informatics. Results showcased strong predictive performance with five-year area under the curve (AUC) scores reaching up to 0.80, underscoring its reliability across diverse screening groups in the United States and Canada. Furthermore, the studies indicated consistent performance outcomes regardless of variations such as age, race, or breast density, pointing to its potential for equitable adoption in clinical settings.

Dr. Graham Colditz expressed the significance of image-based risk evaluation in revolutionizing breast cancer prevention strategies. He noted, "Our research shows that deriving five-year absolute risk estimates from mammography can be significantly discriminative and accurately calibrated to U.S. disease incidence rates. This empowers clinicians to pinpoint women who may benefit from tailored screening or preventative measures. Lunit's advancement of this technology toward regulatory review offers an avenue for integrating evidence-backed, personalized risk assessments into everyday clinical practice."

The model previously garnered the FDA Breakthrough Device Designation, and Lunit has been actively engaged in the FDA’s Total Product Lifecycle Advisory Program (TAP). This initiative facilitates structured and ongoing dialogues with the FDA throughout the development and assessment process. Moreover, the program supports conversations with various stakeholders beyond the FDA to accelerate market integration, enhance clinical use, and broaden patient access to such innovative tools.

CEO Brandon Suh highlighted this 510(k) submission as a landmark moment for Lunit, enhancing personalized breast cancer screening initiatives. He stated, "With our AI-driven Lunit INSIGHT Risk providing guideline-aligned five-year risk predictions directly from routine images, we aim to foster earlier and more informed choices in preventive health care strategies. This approach is designed to guide health systems in applying practical risk-stratified methodologies as screening recommendations increasingly adapt to personalized, risk-informed pathways. Our submission heralds not just a scientific achievement but a strategic move to align Lunit's offerings with the evolving requirements of healthcare systems and patients."

Lunit INSIGHT Risk is engineered to seamlessly integrate within Lunit's comprehensive breast health portfolio. This includes Lunit INSIGHT MMG and DBT detection models, as well as Volpara Risk Pathways, developing a robust framework for risk-informed customer care workflows that encompass assessment, imaging, reporting, and ongoing follow-up.

About Lunit

Founded in 2013, Lunit (KRX: 328130) is on a mission to tackle cancer through innovative AI solutions. Its clinically validated offerings cover a wide spectrum, including medical imaging, breast health, and biomarker analysis, facilitating earlier detection, informed treatment decisions, and improved outcomes throughout the cancer care continuum. Lunit provides a rich array of services, addressing risk prediction and early detection to precision oncology. Their FDA-cleared Lunit INSIGHT suite alongside breast health solutions is implemented in thousands of medical institutions around the globe, while their Lunit SCOPE platform partners with major pharmaceutical and lab leaders for biomarker research and companion diagnostic development. Trusted by over 10,000 sites in more than 65 countries, Lunit merges extensive medical knowledge with an ever-evolving dataset to create a measurable impact across patient care, clinical practice, and research. With its base in Seoul and offices worldwide, Lunit is at the forefront of the international effort against cancer. For more information, visit lunit.io/en.