[Edaily Reporter Shin Ha-yeon ] GenCurix ( Gencurix Inc.(229000)), a company specializing in molecular diagnostics for cancer, announced on the 23rd that the results of a clinical study on its early-stage liver cancer diagnostic test, “HEPA eDX,” have been published in the international academic journal *Epigenetics*.

This study, which evaluated the effectiveness of a technology that diagnoses liver cancer at an early stage by analyzing the methylation patterns of circulating tumor DNA (ctDNA) in the blood, was conducted on a total of 186 participants.

The study results showed that HEPA eDX achieved a sensitivity of 75.0%, a specificity of 93.7%, and an AUC (area under the curve) of 0.90. This significantly exceeds the sensitivity of 56.7% for the existing standard blood test, the alpha-fetoprotein (AFP) test.

In particular, when the AFP test and HepaIDX were used together, they achieved a sensitivity of 91.7% and a specificity of 93.7%. Even in the early-stage liver cancer patient group (BCLC 0-A), the test demonstrated a sensitivity of 87.8%, confirming its potential as an early-diagnosis test.

Sensitivity refers to the proportion of actual patients identified as positive, while specificity refers to the proportion of healthy individuals identified as negative.

In evaluations of patients with non-alcoholic steatohepatitis (MASLD) and alcoholic fatty liver disease, it also recorded a specificity of 90.0%, suggesting its potential as a screening test for high-risk groups for liver cancer.

The research team predicted that since HepaIDX can also detect liver damage, its scope of application could be expanded in the future to include monitoring for recurrence after liver cancer surgery and liver transplantation, as well as the detection of minimal residual disease (MRD).

Professor Wang Hee-jeong of Inje University Haeundae Paik Hospital, the corresponding author of the paper, stated, “Liver cancer is a disease in which early diagnosis significantly determines the prognosis,” adding, “Since it can screen for liver cancer with high accuracy using only a small amount of blood, it has high potential for application in surveillance programs for high-risk groups.”

Moon Young-ho, Vice President of Gencurix Inc., added, “HepAIDX combines a biomarker we discovered in-house with digital PCR technology to ensure superior performance and cost-effectiveness compared to competing products,” and noted, “Starting with the sale of research-use products and testing services, we will pursue entry into the standard screening system following approval from the Ministry of Food and Drug Safety.”

Meanwhile, Gencurix Inc. was recently selected as a joint R&D partner for the “Inter-ministerial Advanced Medical Device R&D Project” led by BioTNS under the Inter-ministerial Medical Device R&D Consortium. Gencurix Inc. plans to use this project as an opportunity to elevate its development and validation system for the early diagnosis of gastrointestinal cancers to world-class standards and to accelerate the global commercialization of in vitro diagnostic products based on its digital PCR platform.