YONGIN, South Korea — November 27, 2025: GC Genome has announced the publication of its landmark study on a blood-based colorectal cancer (CRC) screening test in the American Journal of Gastroenterology, validating the performance of its proprietary AI-driven fragmentomics platform used in the Company’s multi-cancer early detection test, ai-CANCERCH. Conducted in collaboration with Professor Byeon Jeong-Sik’s team at Asan Medical Center, the study evaluated 1,677 individuals, including patients with colorectal cancer, advanced adenomas, and healthy controls, and demonstrated compelling diagnostic accuracy that may reshape early detection strategies for one of the world’s most common and preventable cancers.
Science Significance
This study represents an important scientific advance in the evolution of liquid biopsy diagnostics, showing that cfDNA fragmentomics combined with low-coverage whole genome sequencing (Lc-WGS) and a proprietary AI algorithm can deliver highly sensitive and specific early-stage detection of colorectal cancer. The assay achieved 90.4% CRC sensitivity, 94.7% specificity, and robust detection performance across disease stages—including 84.2% sensitivity in stage I, rising to 100% in stage IV—proving that fragmentomic signatures can accurately capture tumor-derived signals even in early-stage disease. Importantly, the test also demonstrated 90.0% sensitivity for T1N0 lesions, which are eligible for endoscopic resection and represent the earliest phases of tumor development, and 58.3% sensitivity for advanced adenomas, reinforcing the test’s ability to identify precancerous conditions. These scientific outcomes highlight the widening potential of non-invasive, genomics-enabled CRC screening, supporting the shift toward blood-based early detection as a complement or alternative to colonoscopy and fecal immunochemical tests.
Regulatory Significance
The high-performance data published in a leading gastroenterology journal strengthens the regulatory pathway for cfDNA-based colorectal cancer screening assays, which must demonstrate analytical validity, clinical validity, and clinical utility to progress toward broader clinical adoption. As governments and regulatory authorities continue evaluating liquid-biopsy screening methods, peer-reviewed evidence of accuracy across demographic groups, tumor locations, and early-stage disease serves as a critical foundation for risk-benefit assessment and future guideline inclusion. With sensitivity maintained regardless of tumor site (left vs. right colon) and age group (<60 vs. ≥60), the findings help support a regulatory case for population-wide screening eligibility, while also underscoring the need for standardized, quality-controlled cfDNA workflows aligned with cGCP, cGLP, and diagnostic validation frameworks.
Business Significance
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The publication further positions GC Genome as a rising global leader in AI-enabled cancer diagnostics, expanding commercial opportunities across screening partnerships, hospital networks, and international clinical collaborations. The Company’s flagship test, ai-CANCERCH, launched in 2023, already detects multiple cancer types using only 10 mL of blood, and a planned upgrade in January 2026 will expand coverage from 6 cancers to 10, including gastrointestinal, thoracic, hepatobiliary, and gynecologic cancers. With demand for non-invasive cancer screening rising worldwide, these results provide GC Genome with significant commercial momentum, reinforcing investor confidence, supporting market expansion strategies, and demonstrating clear differentiation in a rapidly growing early-detection sector driven by precision genomics, AI algorithms, and scalable laboratory infrastructure.
Patients’ Significance
For patients, especially those hesitant or unable to undergo colonoscopy, this advancement offers a convenient, minimally invasive, and highly accurate alternative that could dramatically improve screening rates and early intervention outcomes. Colorectal cancer remains highly treatable when detected early, yet screening adherence remains suboptimal globally due to discomfort, accessibility barriers, and resource limitations. A blood-based test with strong accuracy for both colorectal cancer and precancerous lesions provides a critically needed option that enhances participation, reduces disparities, and allows earlier detection across diverse populations. The consistency of results across tumor locations and patient age strengthens the clinical value of this test as a patient-friendly solution that supports early intervention, quality of life, and long-term survival.
Policy Significance
The study’s publication arrives at a pivotal time as healthcare systems worldwide reassess national CRC screening programs and explore the integration of liquid biopsy and AI-driven diagnostics into standard-of-care frameworks. With policymakers increasingly focused on population screening efficiency, health equity, and cost-effective preventive strategies, the validation of GC Genome’s fragmentomics test contributes important evidence supporting broader adoption of blood-based screening technologies. As multi-cancer early detection becomes a strategic priority across public health and oncology guidelines, this research strengthens the case for future policy inclusion, pilot programs, reimbursement considerations, and government-supported screening expansion.
By demonstrating strong accuracy and early-stage detection performance, GC Genome’s blood-based screening technology marks a meaningful step toward transforming colorectal cancer prevention and reshaping global diagnostic pathways. As the Company accelerates clinical collaborations and prepares new assay expansions, its AI-enabled cfDNA platform is poised to play an increasingly influential role in the future of precision oncology and population-scale cancer screening.
Source: GC Genome press release
