Zencurix Develops Cervical Cancer Mutation Test... "Expanding Liquid Biopsy Companion Diagnostic Product Line"

[Asia Economy Reporter Hyungsoo Park] GenCurix, a liquid biopsy molecular diagnostics developer, announced on the 23rd that it has developed a uterine endometrial cancer mutation diagnostic test product called ‘Droplex POLE’ and plans to conduct clinical trials for approval from the Ministry of Food and Drug Safety within this year. The company plans to continuously expand the companion diagnostic Droplex product line, including uterine cancer products.

This test analyzes the genes of uterine endometrial cancer patients using the Droplet Digital Polymerase Chain Reaction (ddPCR) platform and detects the presence of mutations in uterine endometrial cancer. The POLE gene, when mutated, induces mutations in various other cancer-related genes such as PTEN, KRAS, and PIK3CA. Prioritizing treatment based on gene mutations leads to better prognosis and reduces unnecessary treatments.

ddPCR is the most suitable diagnostic platform for liquid biopsy, with sensitivity far superior to the conventional real-time polymerase chain reaction (RT-PCR) method, enabling accurate detection of mutations that cannot be detected in blood or small tissue samples. GenCurix is pursuing both domestic and global approvals and sales for the companion diagnostic Droplex products, including the uterine endometrial cancer test. Having established a partnership with Bio-Rad, a global diagnostic company and manufacturer of ddPCR equipment, the company expects overseas marketing to be facilitated.

A company representative stated, "The ddPCR-based Droplex product line optimized for liquid biopsy companion diagnostics is expanding its target areas from non-small cell lung cancer to colorectal cancer, thyroid cancer, melanoma, and uterine cancer." They added, "The ddPCR platform-based world’s first IVD (in vitro diagnostic) product, the non-small cell lung cancer companion diagnostic kit ddEGFR, completed the health insurance reimbursement review by the Health Insurance Review and Assessment Service in January and has started to be covered by health insurance."

Based on ddPCR test development technology, GenCurix recently succeeded in developing eDX, an early diagnostic test for liver cancer and colorectal cancer, and plans to complete approval clinical trials within this year. The company expects to dominate the ddPCR testing market based on its globally recognized technology.

A GenCurix representative said, "One of the most important factors for the commercialization of liquid biopsy is the sensitivity of the test products," adding, "The ddPCR-based companion diagnostic Droplex products enable liquid biopsy with high sensitivity and are expected to replace not only existing RT-PCR but also imaging diagnostic methods such as CT (computed tomography) scans in the field of anticancer treatment monitoring."

They continued, "GenCurix is the only company worldwide to have simultaneously succeeded in developing early diagnostic and companion diagnostic products using next-generation ddPCR technology," emphasizing, "We will focus on research and development to accelerate product commercialization and continuously release additional products targeting various cancer types."

Meanwhile, uterine cancer is one of the three major gynecological cancers, with over one million new patients worldwide annually, and the number of uterine endometrial cancer patients has rapidly increased in Korea since 2000.

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