- Lunit SCOPE HER2 and Lunit SCOPE ER/PR significantly improve pathologist concordance and accuracy, paving the way for improved breast cancer molecular subtype analysis for informed decision-making and precision patient care

SEOUL, South Korea, March 14, 2024 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced the publication of a new study featuring Lunit SCOPE HER2 and Lunit SCOPE ER/PR, Lunit's AI-powered analyzer of human epidermal growth factor receptor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR).

The study, in collaboration with Prof. So-Woon Kim from Kyung Hee University College of Medicine and Prof. Minsun Jung from Yonsei University College of Medicine, was recently published in the Breast Cancer Research (BCR), an international peer-reviewed journal. The study aimed to evaluate the role of Lunit SCOPE in enhancing pathologists' consistency and accuracy of breast cancer molecular subtype classification, including expression levels of HER2, ER, and PR.

Breast cancer treatment strategies and clinical outcome predictions heavily rely on the accurate determination of these receptors' expression levels. However, conventional immunohistochemistry (IHC) analysis poses challenges to classification accuracy. There can be variability in interpretation among pathologists, especially when dealing with intermediate expressions.

The study highlights Lunit SCOPE HER2 and Lunit SCOPE ER/PR, developed using a dataset of thousands of HER2, ER, and PR-stained IHC breast cancer whole-slide images. An external validation cohort of 201 breast cancer cases underwent analysis using these AI analyzers.

Results from the study demonstrated a significant increase in agreement among pathologists on the status of HER2, ER, and PR, especially in cases with intermediate weakly positive expressions. Notably, AI assistance led to an increase in agreement on HER2 status from 49.3% to 74.1%, ER from 93.0% to 96.5%, and PR from 84.6% to 91.5%. This improvement was particularly pronounced in intermediate weakly positive cases with HER2 2+ and HER2 1+, showing concordance increases from 46.2% to 68.4% and 26.5% to 70.7%, respectively. Consequently, with AI assistance, the agreement among pathologists in classification of breast cancer molecular subtypes saw an increase from 58.2% to 78.6%.

The study concludes that Lunit SCOPE HER2 and Lunit SCOPE ER/PR significantly improve pathologists' concordance in classifying breast cancer molecular subtypes. These solutions hold immense potential in enhancing treatment strategies and ensuring more accurate and personalized approaches for patients.

"In this study, not only do we validate the performance of Lunit SCOPE HER2 and Lunit SCOPE ER/PR, but we also reveal the potential application of AI biomarkers in predicting treatment responses, particularly for HER2-targeted therapies. We also expect this breakthrough to open new avenues for future drug development," said Brandon Suh, CEO of Lunit. "At Lunit, we enhance healthcare providers' accuracy and concordance, and we empower them to make informed decisions that directly impact patients' lives. Our mission is to transform the landscape of personalized cancer diagnostics and therapeutics."

About Lunit

Founded in 2013, Lunit is a deep learning-based medical AI company on a mission to conquer cancer. We are committed to harnessing AI to ensure accurate diagnosis and optimal treatment for each cancer patient using AI-powered medical image analytics and AI biomarkers.

As a medical AI company grounded on clinical evidence, our findings are presented in major peer-reviewed journals, such as the Journal of Clinical Oncology and the Lancet Digital Health, and global conferences, including ASCO and RSNA.

After receiving FDA clearance and the CE Mark, our flagship Lunit INSIGHT suite is clinically used in approximately 3,000+ hospitals and medical institutions across 40+ countries. Lunit is headquartered in Seoul, South Korea, with offices and representatives worldwide. For more information, please visit lunit.io.

About Lunit SCOPE

Lunit SCOPE is a suite of AI-powered software that analyzes tissue slide images for digital pathology and AI biomarker development, aiming to optimize workflow and facilitate more accurate and predictive clinical data for clinicians and researchers.

Lunit SCOPE platform offers multiple AI-powered tissue analysis products and assays that can streamline digital pathology workflow and diagnostics and enhance the drug development process.

Lunit SCOPE IO analyzes the tumor microenvironment (TME) based on H&E analysis and provides AI-based predictive clinical outcome information. In addition, AI-driven Immunohistochemistry (IHC) slide analysis services are offered through products such as Lunit SCOPE PD-L1, Lunit SCOPE HER2, Lunit SCOPE ER/PR, and others.