# Digital PCR and BCR::ABL1 monitoring kits (QXDx, Fastplex, Xpert BCR-ABL Ultra)

Source: https://onco.cc/technologies/digital-pcr-platforms/  
OnCo record `digital-pcr-platforms` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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).

## Fields

- Kind: Technology
- Status: established
- Last checked: 2026-11-04
- Also known as: Digital PCR; Droplet digital PCR; ddPCR; QXDx; BCR-ABL monitoring; International Scale; Xpert BCR-ABL Ultra; Quantidex
- Tags: devices-gaps-2026-11
- Principle: 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.
- Since: 2016
- Strengths: Absolute quantification sensitive enough for deep molecular response; Reported on the International Scale for CML
- Limitations: Cleared kits cover common transcripts only (e13a2, e14a2); Not for diagnosis

## Sources

- FDA product code OYX: BCR/ABL1 monitoring test: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=OYX
- FDA De Novo DEN160003: Quantidex qPCR BCR-ABL IS kit: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN160003
- FDA 510(k) K181661: QXDx BCR-ABL %IS kit (13 February 2019): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181661
- FDA 510(k) K221869: Sniper BCR-ABL1 (p210) %IS digital PCR kit (5 September 2023): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221869
- FDA 510(k) K252243: Fastplex BCR-ABL (p210) %IS digital PCR kit (2 July 2026): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252243
- FDA 510(k) K190076: Xpert BCR-ABL Ultra (27 September 2019): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190076
- FDA product code PHG: droplet digital PCR system: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=PHG

## Connected records

- cancers: [Chronic myeloid leukaemia (CML)](https://onco.cc/cancers/cml/)
- fronts: [Devices & Physical Therapies](https://onco.cc/fronts/devices/), [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/)
- technologies: [Flow cytometers](https://onco.cc/technologies/flow-cytometers/), [Haematology analysers and digital blood film and marrow morphology (Sysmex XN, DxH 900, CellaVision, Scopio)](https://onco.cc/technologies/haematology-analysers/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/)

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