Lunit, a medical artificial intelligence (AI) company, announced on Monday that the National Comprehensive Cancer Network (NCCN) has incorporated imaging-based risk assessment as a new method for identifying high-risk groups for breast cancer in its recently updated breast cancer screening and diagnosis guidelines.
The NCCN, a nonprofit alliance of leading cancer centers and research institutions in the United States, is widely recognized for its guidelines, which serve as standard protocols for cancer screening and treatment worldwide.
In this latest revision, the NCCN introduced a new criterion for identifying high-risk breast cancer groups: a 5-year risk of invasive breast cancer of 1.7% or higher, as calculated using an imaging-based risk assessment model.
This addition officially incorporates imaging-based breast cancer risk assessment into the guidelines as a method for identifying high-risk groups, alongside traditional clinical risk assessment models that consider factors such as family history, age, and lifestyle.
Under the NCCN guidelines, patients classified as high-risk for breast cancer are recommended to receive personalized management, including risk counseling, adjusted screening schedules, and more advanced supplementary screening tests like magnetic resonsnance imagings (MRIs).
This update signals a growing acceptance of imaging-based AI breast cancer risk prediction technology in clinical practice.
Capitalizing on this trend, Lunit is accelerating efforts to introduce its ‘Lunit Insight Risk’ product to the U.S. market. This AI solution predicts the risk of breast cancer development within five years using only mammography images and patient age data.
Lunit Insight Risk received innovative medical device designation from the U.S. Food and Drug Administration (FDA) in April 2022, followed by a premarket approval application in December of the same year. The company aims to secure approval by 2026.
Seo Beom-seok, Chief Executive Officer (CEO) of Lunit, commented that the NCCN guideline revision marks a significant milestone, indicating that imaging-based AI risk prediction is now entering practical clinical application. He added that it’s fully committed to rapidly establishing Lunit Insight Risk as a key player in the U.S. breast cancer market.
Invasive breast cancer occurs when cancer cells spread beyond the ducts or lobules into surrounding breast tissue. If left untreated, it can potentially metastasize to lymph nodes or other organs, underscoring the critical importance of early detection and treatment.