[Edaily Reporter Kim Hyung-il ] Gencurix Inc.(229000), a company specializing in molecular diagnostics for cancer, announced on the 8th that it presented research findings on “COLO eDX,” a blood-based molecular diagnostic test for colorectal cancer, at the International Congress of Colorectal Surgery (iCRS 2026), hosted by the Korean Society of Colorectal Surgery.
Professor Song Ji-hyung of Inje University Haeundae Paik Hospital presenting at iCRS 2026, organized by the Korean Society of Colorectal Surgery. (Photo courtesy of Gencurix Inc.)
COLO eDX is a colorectal cancer diagnostic test that uses digital polymerase chain reaction (PCR) to detect multi-gene DNA methylation biomarkers—which Gencurix Inc. identified independently—in blood. Inje University Haeundae Paik Hospital, which conducted the study, developed a digital PCR test using DNA methylation biomarkers selected through large-scale epigenomic analysis and conducted an exploratory evaluation of its performance using clinical samples.
According to the study results, analysis of preoperative colorectal cancer patients and a healthy control group using ColoiDX showed a sensitivity of 79.4% and a specificity of 92.6%.
In addition to its performance in detecting colorectal cancer, the study also evaluated the potential of ColoiDX for early monitoring of postoperative recurrence. Among the four patients in whom recurrence was confirmed within one year after surgery, three consistently showed high levels corresponding to a positive ColoiDX result even before clinical recurrence was confirmed. Gencurix Inc. explained that this confirms the potential of ColoiDX to be used not only for detecting colorectal cancer but also for monitoring early postoperative recurrence.
Colon cancer carries a risk of recurrence even after curative surgery, making continuous follow-up crucial. Currently, blood tests for carcinoembryonic antigen (CEA) and computed tomography (CT) scans are primarily used, but they have limitations in detecting minimal residual disease (MRD) or early-stage recurrence. Consequently, interest is growing in liquid biopsy-based molecular diagnostic technologies that use blood to detect signs of recurrence at an early stage.
Professor Song Ji-hyung of Inje University Haeundae Paik Hospital, who presented the study, stated, “It is significant that blood-based molecular signals were observed in patients with postoperative recurrence even before clinical recurrence was confirmed,” adding, “We plan to verify the clinical utility of recurrence monitoring through long-term follow-up involving a larger number of patients.”
Han Jin-il, a director at Gencurix Inc., said, “Through this study, we confirmed the applicability of the methylation biomarker we discovered in-house and digital PCR technology.” He added, “We plan to develop this into a blood-based test that covers both colorectal cancer diagnosis and postoperative monitoring through future clinical validation and data accumulation.”
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