Lunit, a Korean medical AI company, said Monday that it expects to gain momentum in the U.S. breast cancer risk prediction market after the National Comprehensive Cancer Network (NCCN) newly included imaging-based risk assessment in its latest breast cancer screening and diagnosis guidelines.
The NCCN, a nonprofit alliance of leading U.S. cancer centers and research institutes, publishes widely recognized clinical guidelines that serve as global standards for cancer screening and treatment.
Under the revised guidelines, the NCCN added a new criterion for identifying high-risk breast cancer patients: women with a five-year invasive breast cancer risk of 1.7 percent or higher as calculated by imaging-based risk assessment models.
The update officially recognizes imaging-based breast cancer risk evaluation as one of the methods for identifying high-risk groups, alongside traditional clinical risk assessment models based on factors such as family history, age and lifestyle habits.
Patients classified as high risk under the NCCN guidelines are recommended to receive enhanced management, including risk counseling, adjusted screening intervals, and additional imaging tests such as MRI scans. Industry observers expect the revision to significantly influence breast cancer screening practices in the U.S., as accurate identification of high-risk patients is considered critical for early cancer detection and improved prognosis.
The guideline revision is also seen as a meaningful step toward broader clinical adoption of AI-powered imaging risk prediction technologies. While imaging-based AI risk assessment has largely remained at the stage of technical validation, NCCN’s recognition opens the door to its use in standard clinical practice.
In response, Lunit plans to accelerate its entry into the U.S. market with Lunit INSIGHT Risk, an AI solution that predicts a patient’s five-year breast cancer risk using only mammographic images and age. The company says the product can generate individualized absolute risk scores without requiring complex questionnaires, genetic testing or blood tests.
Lunit INSIGHT Risk was designated a Breakthrough Device by the FDA in April last year, and the company subsequently submitted a 510(k) premarket notification application in December. Lunit aims to obtain FDA clearance by 2026.
“This NCCN guideline revision signifies that imaging-based AI risk prediction has moved beyond technical feasibility and entered the stage of real-world clinical adoption,” Lunit CEO Brandon Suh said. “Once we secure FDA clearance, we will focus all of our capabilities on rapidly establishing Lunit INSIGHT Risk in the U.S. breast cancer screening market.”
Kim Ji-hye
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