[Edaily Reporter NA EUN-KYUNG ] Medical artificial intelligence (AI) company Lunit Inc.(328130)will participate in a county-wide breast cancer screening program in Stockholm County, Sweden. “Lunit Inc. Insight MMG,” which was introduced into actual clinical practice following clinical trials that began at local hospitals in 2021, has been expanded to a county-wide screening program in approximately five years.

Lunit Inc. announced on the 28th that Stockholm County, Sweden, is adopting the “Lunit Insight MMG” AI-powered mammography image analysis solution for breast cancer screening across the entire county. Accordingly, Lunit Inc. will supply the solution in collaboration with Sectra, a Swedish medical imaging company.

The solution will be supplied to three hospitals responsible for breast cancer screening in Stockholm County: Capio S Göran Hospital, Karolinska University Hospital, and Södersjukhuset.

A key feature of this implementation is that the AI will not merely assist radiologists in interpreting images but will act as an independent reader. In Europe’s national breast cancer screening programs, a “double reading” process is typically used, in which two radiologists each review the images independently. In Stockholm County, Lunit Inc. Insight MMG will replace one of the two radiologists, so the system will operate with one radiologist and the AI each interpreting the images.

Lunit Inc. Insight MMG is AI software that analyzes mammography images to highlight areas suspected of breast cancer and indicate the potential presence of lesions. It has obtained CE certification in accordance with the European Union Medical Device Regulation (EU MDR) and is currently available in Europe.

This implementation in Stockholm County is based on clinical research and real-world experience conducted locally over approximately five years. The starting point was the prospective study “ScreenTrustCAD,” conducted by researchers at the Royal Karolinska Institute and St. Göran’s Hospital. From April 2021 to June 2022, the research team evaluated Lunit Inc. Insight MMG in 55,579 women who underwent breast cancer screening. They compared the traditional dual-reader method—using two specialists—with a method combining one specialist and AI in a real-world screening setting.

The results showed that the cancer detection rate for the method combining one radiologist with Lunit Inc. Insight MMG was 4.3 cases per 1,000 women, which was higher than the 4.1 cases per 1,000 women for the conventional dual-reader approach using two radiologists. The call-back rates were 28 and 29.3 cases per 1,000 women, respectively. The cancer detection rate for AI-only interpretation was also 4.1 cases per 1,000 women. Following their presentation at the 2022 Radiological Society of North America (RSNA) Annual Meeting, the study results were published in the international journal *The Lancet Digital Health*.

Based on these findings, St. Göran’s Hospital entered into a contract with Lunit Inc. in 2023 and began using Lunit Insight MMG in actual breast cancer screening. This approach replaces one of the two specialists previously involved in interpretation with AI.

According to Lunit Inc., St. Goran’s Hospital has since used Lunit Insight MMG to interpret approximately 200,000 mammography images over the past three years. This project in Stockholm County represents a step toward expanding the research and real-world experience accumulated at a single medical institution to the region’s broader breast cancer screening system.

This marks the second time that Lunit Inc.’s AI has been adopted for regional breast cancer screening in Sweden, following its implementation in Dalarna County. Lunit Inc. is expanding its scope from supplying individual healthcare institutions to county-wide screening programs.

The company is also expanding its participation in public breast cancer screening programs across Europe. Last year, Lunit Inc. was selected as the AI solution provider for the breast cancer screening program in the Valencian Community, Spain. The Valencian Community, with a population of approximately 5 million, is pursuing the adoption of AI as part of its effort to increase annual breast cancer screening participation from approximately 250,000 to 400,000.

This project in Stockholm County is particularly significant in that AI goes beyond serving merely as an auxiliary tool for interpretation and becomes an integral part of the existing dual-reader system. As efforts continue across Europe to apply AI to the interpretation process in response to a shortage of radiology specialists and an increase in screening volumes, Lunit Inc. plans to expand its participation in large-scale screening programs based on local clinical research and real-world data.

Dr. Karin Dembrower of St. Göran’s Hospital stated, “The AI-assisted interpretation method, which was initially evaluated and adopted at a single hospital, is now being utilized across the entire breast cancer screening system in Stockholm County,” adding, “This is the result of verifying our progress step by step, from clinical research through to real-world validation.”

Seo Beom-seok, CEO of Lunit Inc., remarked, “This supply agreement with Stockholm County is an example of how our accumulated clinical evidence has led to actual implementation and entry into the broader healthcare system,” adding, “Following our work in Dalarna County, we will expand our participation in regional breast cancer screening programs in Sweden and broaden our footprint in the European market.”