Bio-Rad Releases First CE-IVD Digital PCR Test for Monitoring Chronic Myeloid Leukemia Response to Therapy

Bio-Rad Laboratories, Inc. has announced the launch of the QXDx BCR-ABL %IS Kit, the first CE-IVD digital PCR test that can monitor the molecular response of patients with chronic myeloid leukemia (CML) to therapy, and it does so more precisely and reliably than other available technologies.

Chronic myeloid leukemia, or CML, is characterized by the "Philadelphia chromosome," a translocation of chromosomes 9 and 22 that results in BCR-ABL gene fusion. Tyrosine kinase inhibitors can target BCR-ABL kinase activity and can transform CML into a manageable chronic disease for many patients.

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The global standard of care for managing CML, measuring BCR-ABL mRNA, however, falls short of clinicians' needs. There remains significant variation between laboratories as well as within laboratories that are using existing reverse transcription quantitative PCR (RT-qPCR) methods, which are not sensitive enough to determine whether a patient can discontinue therapy without risking disease recurrence.

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 values of MR 4.7 or 5.0 in 2- or 4-well formats, which exceeds typical limitations of 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.

"Bio-Rad's ddPCR system is a powerful solution for monitoring patients treated for CML," said Dr. Niels Pallisgaard, from the Department of Pathology at Zealand University Hospital in Denmark. "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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With its CE-IVD marking, the kit is available for diagnostic use in Europe, Hong Kong, and New Zealand. It can be used with Bio-Rad's QX200 AutoDG ddPCR Dx System or with the QX200 ddPCR Dx System. The QXDx BCR-ABL %IS Kit uses QuantaSoft Software v1.7 for data acquisition and output.

Additional benefits of the QXDx BCR-ABL %IS Kit include:

• Reproducible results -- absolute quantitation eliminates the need for standard curves and minimizes variation between samples
• Scalable throughput -- test from 8 to 48 samples per run to meet any clinical laboratory's throughput needs
• High specificity -- detect abnormal transcripts that encode for p210 hybrid BCR-ABL protein associated with CML, but not p190, which is associated with acute lymphoblastic leukemia