Zencurix Selected for Innovative Medical Device Demonstration Support Program for Liquid Biopsy Early Diagnosis of Liver Cancer

[Asia Economy Reporter Hyunseok Yoo] GenCurix, a liquid biopsy molecular diagnostics specialist company, announced on the 25th that it has been selected for the ‘Corporate Validation Support Program’ of the Ajou University Hospital Innovative Medical Device Validation Support Center, designated by the Ministry of Health and Welfare and the Korea Health Industry Development Institute. With this selection, research using human-derived materials to validate the liquid biopsy early liver cancer diagnosis product ‘HEPA_eDX (hereafter HEPA_eDX)’ will be conducted at Ajou University Hospital.

The Innovative Medical Device Validation Support Center’s Corporate Validation Support Program is a project that discovers excellent results of highly innovative medical devices early and supports research aimed at commercialization, providing support for clinical and non-clinical validation evaluations of innovative medical devices.

HEPA_eDX is an early liver cancer diagnosis product utilizing methylation biomarkers. Last year, it completed product performance validation by demonstrating excellent cancer diagnostic accuracy through the Ajou Medical Center Genome Center. This research is being conducted to complete the final product format with the goal of approval from the Ministry of Food and Drug Safety, and once the validation evaluation is completed, formal approval from the Ministry of Food and Drug Safety is planned within the year.

The company stated, “HEPA_eDX overcomes the sensitivity limitations of existing liquid biopsy-based diagnostic products by using the next-generation diagnostic platform ddPCR (droplet digital PCR),” and added, “By increasing the liver cancer diagnostic specificity of the test through proprietary biomarker discovery technology, it has come closer to the commercialization of liquid biopsy early diagnosis products.”

ddPCR is a next-generation digital PCR platform that improves sensitivity and specificity through independent PCR (polymerase chain reaction) reactions within tens of thousands of droplets. Following GenCurix’s lung cancer companion diagnostic product ‘GenesWell ddEGFR Mutation Test’ and the gene mutation detection test for various cancer types ‘Droplex,’ the ddPCR platform is also applied to this early diagnosis, utilizing the company’s technological know-how.

A GenCurix research institute official said, “We are very pleased that the clinical research of HEPA_eDX, which is leading the field of liquid biopsy early diagnosis, has been recognized for its technology and marketability and selected for the Corporate Validation Support Program of the Ajou University Hospital Innovative Medical Device Validation Support Center, designated by the Ministry of Health and Welfare and the Korea Health Industry Development Institute,” and added, “The EDX series, a liquid biopsy-based early diagnosis product, will expand its product portfolio to include various cancer types starting with liver and colorectal cancers.”