Digital PCR Test Monitors CML Therapy Response

The first CE-IVD digital polymerase chain reaction PCR test has been launched that can monitor the molecular response of patients with CML to therapy, and it does so more precisely and reliably than other available technologies.

The QXDx BCR-ABL %IS Kit provides an absolute measure of BCR-ABL transcripts with high reproducibility, precision, and sensitivity because it uses Bio-Rad's Droplet Digital PCR (ddPCR) technology. The kit is able to detect deep molecular response (MR) values of 4.7 or 5.0 in 2- or 4-well formats, which exceeds typical limitations of reverse transcription quantitative PCR (RT-qPCR)-based tests that are reliable only down to MR 4.5. Its high sensitivity permits disease remission to be assessed more confidently, so can better aid clinicians in disease management decisions.

Additional benefits of the QXDx BCR-ABL %IS Kit include: reproducible results as absolute quantitation eliminates the need for standard curves and minimizes variation between samples; scalable throughput with test from eight to 48 samples per run to meet any clinical laboratory's throughput needs; high specificity that detect abnormal transcripts that encode for p210 hybrid BCR-ABL protein associated with CML, but not p190, which is associated with acute lymphoblastic leukemia.

Niels Pallisgaard, MSc, the chief molecular biologist at Zealand University Hospital (Roskilde, Denmark) said, “Bio-Rad's ddPCR system is a powerful solution for monitoring patients treated for CML. The increased sensitivity, precision, and reproducibility of BCR-ABL measurements without the need for standard curves, as in traditional RT-qPCR methods, lends to the rationale for the use of ddPCR in routine laboratory testing.”

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Zealand University Hospital