ArticlePloS one2022
Performance characteristics of the first Food and Drug Administration (FDA)-cleared digital droplet PCR (ddPCR) assay for BCR::ABL1 monitoring in chronic myelogenous leukemia.
Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed, 17 citations in OpenAlex.
- Next-generation digital polymerase chain reaction assay for BCR::ABL1 in chronic myeloid leukemia: comprehensive validation for standardized measurable residual disease detection.Blood research · 2026Article
- Analytical performance evaluation and method comparison of the 1copy BCR::ABL1 qPCR assay for monitoring chronic myeloid leukemia.Practical laboratory medicine · 2026Article
- Therapeutic Targets for Overcoming BCR::ABL1 Tyrosine Kinase Inhibitor Resistance in Chronic Myeloid Leukemia.Oncology research · 2026Review
- Review
- Rapid and Sensitive Digital Droplet PCR Assays for Detecting HPV16 DNA in Liquid Biopsies.Journal of medical virology · 2025Article
- Quantitative detection of T315I mutations of BCR::ABL1 using digital droplet polymerase chain reaction.Hematology, transfusion and cell therapy · 2024Article
- Laboratory-developed Droplet Digital PCR Assay for Quantification of the JAK2Global medical genetics · 2024Article
- [NGS-based molecular genetics of leukemia-a powerful and decentralized approach].Pathologie (Heidelberg, Germany) · 2023Review
- Droplet Digital PCR for Oncogenic KMT2A Fusion Detection.The Journal of molecular diagnostics : JMD · 2023Article
- MolecularInternational journal of molecular sciences · 2023Article
- Digital and Absolute Assays for Low Abundance Molecular Biomarkers.Accounts of chemical research · 2023Article
- Measurable residual disease in chronic myeloid leukemia.Haematologica · 2022Review
- Clinically relevant fusion oncogenes: detection and practical implications.Therapeutic advances in medical oncology · 2022Review
- Article
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Authors and funding
8 authors at 3 institutions in 1 country.
Funding
Abstract
Chronic myelogenous leukemia (CML) is a hematopoietic stem cell malignancy that accounts for 15-20% of all cases of leukemia. CML is caused by a translocation between chromosomes 9 and 22 which creates an abnormal fusion gene, BCR::ABL1. The amount of BCR::ABL1 transcript RNA is a marker of disease progression and the effectiveness of tyrosine kinase inhibitor (TKI) treatment. This study determined the analytical and clinical performance of a droplet digital PCR based assay (QXDx BCR-ABL %IS Kit; Bio-Rad) for BCR::ABL1 quantification. The test has a limit of detection of MR4.7 (0.002%) and a linear range of MR0.3-4.7 (50-0.002%IS). Reproducibility of results across multiple sites, days, instruments, and users was evaluated using panels made from BCR::ABL1 positive patient samples. Clinical performance of the assay was evaluated on patient samples and compared to an existing FDA-cleared test. The reproducibility study noted negligible contributions to variance from site, instrument, day, and user for samples spanning from MR 0.7-4.2. The assay demonstrated excellent clinical correlation with the comparator test using a Deming regression with a Pearson R of 0.99, slope of 1.037 and intercept of 0.1084. This data establishes that the QXDx™ BCR-ABL %IS Kit is an accurate, precise, and sensitive system for the diagnosis and monitoring of CML.
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Registered trials
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