[Edaily Reporter Shin Ha-yeon ] NGeneBio Co., Ltd.(354200)is expanding its precision medicine business by commencing clinical validation of a next-generation companion diagnostic solution that combines artificial intelligence (AI) and next-generation sequencing (NGS).

NGeneBio Co., Ltd. announced on the 22nd that it has signed a joint research agreement with Professor Kim Tae-jeong’s team from the Department of Pathology at Yeouido St. Mary’s Hospital, Catholic University of Korea, for an “AI·NGS Integrated Companion Diagnostic Solution.” Through this collaboration, the company plans to validate the clinical efficacy of a hybrid companion diagnostic solution—the first of its kind in Korea—that combines AI-based pathological analysis with NGS-based precision diagnostics.

This research will be conducted by comparing and analyzing the diagnostic results of NGeneBio Co., Ltd.’s solution against real-world prescription data from “Oncomine,” a global standard companion diagnostic (CDx) product. The company’s strategy is to use this to verify diagnostic accuracy and secure real-world evidence (RWE) that can be utilized in decision-making regarding the prescription of targeted anticancer drugs in actual clinical settings.

The solution applied in the study combines the AI-powered pathology analysis software “NPAS (NPathAnalySys)” with the NGS precision diagnostics software “NGAS (NGeneAnalySys).” The system is structured such that NPAS screens for potential genetic mutations based on histopathological images, while NGAS performs the final genetic analysis and clinical interpretation.

In particular, it is expected that diagnostic efficiency will be improved by using AI during the lung cancer diagnostic process to first identify patients with a high likelihood of EGFR gene mutations and then performing NGS testing only when necessary. The company explained that this approach can reduce testing failures caused by insufficient tissue samples and the financial burden associated with repeat testing.

The NPAS-EGFR model used in this study incorporates an EGFR mutation prediction model based on “EXAONE Path 2.0,” for which NGeneBio Co., Ltd. secured an exclusive license from LG Corp. earlier this year.

NGeneBio Co., Ltd. plans to complete clinical validation within the year and then apply for digital medical device approval. The company’s strategy is to establish a recurring revenue model by introducing a fee structure based on the number of AI diagnoses and to expand the scope of application from lung cancer to various solid tumors, such as breast and colorectal cancers.

Professor Kim Tae-jeong, who is leading this research, is recognized as an authority in the fields of lung cancer pathology and molecular diagnostics and currently serves on the Pathology Committee of the International Association for the Study of Lung Cancer (IASLC). NGeneBio Co., Ltd. plans to strengthen its foundation for entering the global companion diagnostics market through collaboration with Professor Kim’s research team.

Professor Kim Tae-jeong stated, “Through comparative validation with global standard products, we will secure evidence to support actual clinical prescribing and develop next-generation hybrid diagnostic solutions that can reduce the burden on patients.”

Song Myung-jun, Head of the Diagnostics Business Division at NGeneBio Co., Ltd., remarked, “This is an important milestone in validating AI-based pathology analysis and NGS precision diagnostic technologies in real-world clinical settings,” adding, “We will expand our business beyond precision diagnostics into the realm of prescribing decision support to set a new standard in the global cancer diagnostics market.”