In vitro diagnostic medical devices for cancer refer to medical tools used to analyze samples collected from the human body—such as blood, tissue, urine, or saliva—outside the body to determine the presence of cancer, identify genetic mutations, monitor treatment responses, and assess prognosis.

At Epinode, we collectively refer to this category of diagnostic devices as Y-node.

These devices offer not only early cancer detection but also enable precision medicine, treatment monitoring, and recurrence surveillance. Thanks to recent technological advances, the accuracy and efficiency of these diagnostics have significantly improved. Cancer IVDs can be broadly classified into four categories: immunoassays, molecular diagnostics, cytogenetic analysis, and microscopic pathology-based diagnostics. Among these, molecular diagnostics have advanced rapidly, allowing for the precise analysis of genes, DNA, RNA, and methylation patterns—offering a deeper understanding of the molecular characteristics of cancer. Typically, molecular diagnostic IVD products consist of nucleic acid extraction reagents, amplification reagents, analytical instruments, and data interpretation software. Many of these systems are integrated with automation platforms for faster and more consistent analysis. In particular, technologies that analyze DNA methylation patterns have gained attention for their ability to sensitively detect tumor-specific epigenetic changes, making them especially valuable for early detection. One such example is ColonAiQ, a blood-based methylation test developed for early colorectal cancer screening.

Cancer IVDs are subject to stringent regulatory oversight due to their clinical importance. In Korea, they must be approved by the Ministry of Food and Drug Safety (MFDS), in the United States by the FDA, and in Europe under the IVDR framework. Most cancer-related IVDs are considered high-risk (Class 2 or 3) devices, requiring detailed technical documentation, clinical performance data, and strict compliance with quality management systems (QMS).
In summary, cancer IVDs are a core technology in the era of precision medicine. They are widely applied throughout the full cancer care continuum—from early detection and companion diagnostics to prognosis and treatment monitoring. As genomic analysis, AI-based interpretation, and liquid biopsy platforms continue to evolve, the role of cancer IVDs—what we call Y-node—is expected to grow even more vital in transforming cancer care.