Zencurix Completes Development of Early Cancer Diagnosis Liquid Biopsy Product, Plans Domestic and International Approval After Clinical Trials Within the Year

[Asia Economy Reporter Hyunseok Yoo] Molecular diagnostics specialist GenCurix announced on the 27th that it will complete clinical trials within this year for its liquid biopsy technology for early diagnosis of liver cancer and colorectal cancer and proceed with domestic and international approvals.

GenCurix has completed the development of liquid biopsy products for early diagnosis of liver cancer (HEPA_eDX) and colorectal cancer (COLO_eDX) and is currently conducting clinical trials. Once the trials are completed, the company plans to initiate procedures for global approvals, including from the Korean Ministry of Food and Drug Safety, within this year. While early diagnosis of colorectal cancer has been commercialized successfully by the US company Exact Sciences, the test uses stool samples rather than blood, which has been criticized for convenience and cost issues. Globally, there has been no significant commercial success yet in early diagnosis of liver cancer.

The company stated, “Since cancer can be detected at an early stage with only a small amount of blood, if the ongoing clinical trials are successfully completed, this will become a world-leading innovative technology in the field of early cancer diagnosis.” It added, “We will leverage our proprietary technology to discover high-performance biomarkers and diagnostic kit development capabilities to become a global leader in liquid biopsy.”

Before developing early diagnosis products, GenCurix had already secured core technologies in the companion diagnostics field. The lung cancer companion diagnostic test (GenesWell ddEGFR) received approval from the Ministry of Food and Drug Safety and passed the new medical technology evaluation. Earlier this year, it also completed the health insurance reimbursement review by the Health Insurance Review and Assessment Service, enabling coverage under national health insurance. The company has completed development of a follow-up product with improved performance and is conducting approval clinical trials.

In particular, GenCurix holds core technologies in digital PCR (gene amplification), an area where it has strengths in liquid biopsy. Digital PCR is a third-generation platform that improves sensitivity and accuracy by more than 50 times compared to the conventional RT-PCR (real-time gene amplification) method. This is why GenCurix is confident in its success in the liquid biopsy field, which requires much higher sensitivity than tissue biopsy.

Additionally, through cooperation with ‘Genobio,’ whose majority shareholder status GenCurix recently secured, the company is entering the circulating tumor cells (CTC) field, which is gaining attention in liquid biopsy. Genobio possesses proprietary technology to isolate and analyze CTCs, cancer cells circulating in the blood. Genobio’s CTC device, ‘GenoCTC,’ has obtained Class 1 approval from the Ministry of Food and Drug Safety and can isolate CTCs with significantly higher purity compared to existing products. It can be used in companion diagnostics, cancer treatment monitoring, and early diagnosis.

A GenCurix official said, “Since securing majority shareholder status in Genobio at the end of last year, we have continued cooperation in research and business development,” adding, “We will further strengthen business synergies in the liquid biopsy field and beyond.”

He continued, “Starting this year, based on the commercialization of GenesWell BCT (breast cancer prognosis diagnostic test), we will continuously launch innovative products that meet global market demands in the liquid biopsy field,” emphasizing, “We will accurately identify unmet market needs and strengthen our product portfolio to solidify our position as a leading company in the liquid biopsy market.”

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