[Asia Economy Reporter Hyunseok Yoo] Molecular diagnostics specialist GenCurix is starting clinical trials for its liquid biopsy early liver cancer diagnostic test, HEPA eDX. If the clinical trials succeed, HEPA eDX is expected to become the world's first commercially successful early liver cancer diagnostic product.


On the 22nd, GenCurix stated, "We confirmed from the Ministry of Food and Drug Safety that HEPA eDX, for which we applied for an Investigational New Drug (IND) last month, qualifies for IND approval exemption," adding, "We will begin clinical trials smoothly and proceed with subsequent clinical procedures without any setbacks."


This product can diagnose liver cancer from its early stages using only a small amount of blood. It is expected to be widely used not only for early diagnosis but also for monitoring recurrence in the future.


The clinical trial for early liver cancer diagnosis is led by Professor Wang Hee-jung of Inje University Haeundae Paik Hospital as the principal investigator. Professor Wang is known as a top authority in liver transplantation and hepatobiliary surgery, having served as president of the Korean Liver Cancer Association, the Korean Society of Hepato-Biliary-Pancreatic Surgery, and the Korean Surgical Society.


The company aims to complete the clinical trials by the first quarter of next year and obtain approval from the Ministry of Food and Drug Safety within the first half of the year. Their strategy is to prepare thoroughly to enable an official launch immediately upon approval.



A GenCurix representative said, "Since there are currently no commercially successful products, the value of HEPA eDX technology targeting the global 30 trillion KRW early liver cancer market is very high," adding, "Based on our proven capabilities in discovering proprietary biomarkers and liquid biopsy technology competitiveness, we will continuously strengthen our liquid biopsy early diagnostic portfolio not only for liver cancer but also for other cancers such as colorectal cancer."


This content was produced with the assistance of AI translation services.

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