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Tests that count copies of a cancer gene in a blood sample, used most in chronic myeloid leukaemia to measure how far the BCR::ABL1 signal has fallen on treatment. Digital PCR splits the sample into thousands of droplets and counts the positive ones.
The FDA created product code OYX for BCR::ABL1 monitoring tests (21 CFR 866.6060) with Asuragen's Quantidex qPCR BCR-ABL IS kit (De Novo DEN160003, 22 July 2016). Bio-Rad's QXDx BCR-ABL %IS kit on the QXDx AutoDG ddPCR system (K181661, 13 February 2019) measures BCR::ABL1 to ABL1 on the International Scale "in t(9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors" and "is not intended for the diagnosis of CML". Digital PCR kits from China followed: Suzhou Sniper Medical's BCR-ABL1 (p210) %IS kit (K221869, 5 September 2023) and Suzhou Precigenome's Fastplex (K252243, 2 July 2026). Cepheid's Xpert BCR-ABL Ultra on GeneXpert (K190076, 27 September 2019) is a cartridge quantitative PCR test. The droplet digital PCR instrument itself has its own code, PHG (21 CFR 862.2570).
The sample is partitioned into thousands of droplets or wells so each holds zero or a few target molecules; after PCR, the fraction of positive partitions gives an absolute count by Poisson statistics without a standard curve.
Query for this technology: (TITLE:"Digital PCR and BCR::ABL1 monitoring kits" OR ABSTRACT:"Digital PCR and BCR::ABL1 monitoring kits" OR TITLE:"QXDx, Fastplex, Xpert BCR-ABL Ultra" OR ABSTRACT:"QXDx, Fastplex, Xpert BCR-ABL Ultra" OR TITLE:"Digital PCR" OR ABSTRACT:"Digital PCR" OR TITLE:"Droplet digital PCR" OR ABSTRACT:"Droplet digital PCR") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Digital PCR and BCR::ABL1 monitoring kits (QXDx, Fastplex, Xpert BCR-ABL Ultra), not a curated reading list.
Shares Haematology analysers and digital blood film and marrow morphology (Sysmex XN, DxH 900, CellaVision, Scopio), Flow cytometers and the tag devices-gaps-2026-11.
Shares Haematology analysers and digital blood film and marrow morphology (Sysmex XN, DxH 900, CellaVision, Scopio) and the tag devices-gaps-2026-11.
Shares Haematology analysers and digital blood film and marrow morphology (Sysmex XN, DxH 900, CellaVision, Scopio) and the tag devices-gaps-2026-11.
Shares Haematology analysers and digital blood film and marrow morphology (Sysmex XN, DxH 900, CellaVision, Scopio), Flow cytometers.
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