cfDNA Detection

cfDNA Detection

Circulating cell-free DNA (cfDNA), as a core liquid biopsy biomarker, plays a pivotal role in cancer early screening, minimal residual disease (MRD) monitoring, therapeutic efficacy evaluation, and prognosis prediction. cfDNA detection also serves as an important tool for assessing the in vivo safety of cell and gene therapy products, enabling monitoring of post-treatment genomic instability, clonal hematopoiesis, and long-term tumorigenic risk. GeneRulor's cfDNA detection platform focuses on two core technologies: low-frequency variant capture and DNA methylation analysis. Low-frequency variant detection employs ultra-deep targeted sequencing (sequencing depth up to 10,000–50,000×) combined with Unique Molecular Identifier (UMI) technology and advanced bioinformatics algorithms, achieving ultra-sensitive detection of variant allele frequencies as low as 0.01% for precise identification of driver mutations, resistance mutations, and clonal evolution trajectories within ctDNA. DNA methylation detection enriches methylation sites through bisulfite conversion or enzyme digestion, profiling epigenetic markers in cfDNA to enable tumor tissue-of-origin tracing, tumor burden quantification, and early diagnosis. MRD detection for hematologic malignancy and solid tumor patients tracks patient-specific somatic mutations or methylation markers during post-treatment remission to assess residual tumor cell burden, predict relapse risk, and guide subsequent treatment decisions. This technology holds significant value for efficacy monitoring and long-term safety follow-up after CAR-T therapy, enabling dynamic monitoring of tumor burden changes, CAR-T expansion kinetics, and potential secondary malignancy signals. The platform complies with clinical laboratory quality management system requirements, providing highly sensitive and highly specific molecular diagnostic support for precision medicine and individualized therapy.