Comparative analysis of a novel next-generation sequencing-based IGH clonality assay for measurable residual disease detection in pediatric B-cell acute lymphoblastic leukemia patients

• DOI: 10.1080/08880018.2025.2463927
• Publication Date: 2025-02-13T10:55:51Z
• Authors: Min-Seung Park; Hee Young Ju; Ji Won Lee; Keon Hee Yoo; Hee-Jin Kim; Duck Cho; Hyun-Young Kim
• Keywords: Minimal Residual Disease

Measurable residual disease (MRD) is critical in guiding therapeutic strategies for B-cell acute lymphoblastic leukemia (B-ALL). This study evaluated the performance of a novel next-generation sequencing-based Celemics IGH assay (CM-IGH; Celemics, Seoul, Korea) compared with LymphoTrack® FR1 (LT-IGH; Invivoscribe Technologies, USA) and multiparameter flow cytometry (MFC). A total 31 diagnostic 60 follow-up bone marrow aspirate samples, all from same pediatric patients B-ALL, were analyzed using CM-IGH LT-IGH assays on MiSeq platform, as well MFC according to EuroFlow guidelines. Initial clonality was detected 83.9% samples 90.3% (p = 0.060). MRD positivity rates 74.5% CM-IGH, 61.1% LT-IGH, 56.7% MFC. showed concordance 78.3% 68.1% MFC, while demonstrated an 81.5% rate The correlation coefficients (r) levels 0.831 between 0.702 0.776 demonstrates substantial detecting highlighting complementary value