Bio-Rad Laboratories Inc, Hercules, Calif, has introduced the QXDx BCR-ABL %IS kit, a CE-marked digital polymerase chain reaction (PCR) test that can monitor the molecular response to therapy of patients with chronic myeloid leukemia (CML).

CML is characterized by the ‘Philadelphia chromosome,’ a translocation of chromosomes 9 and 22 that results in BCR-ABL gene fusion. For many patients, tyrosine kinase inhibitors can target BCR-ABL kinase activity and can transform CML into a manageable chronic disease.

The QXDx BCR-ABL %IS kit provides an absolute measure of BCR-ABL transcripts using 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, exceeding the limitations of RT-qPCR-based tests, which are typically reliable only to MR 4.5. The high sensitivity of the QXDx BCR-ABL %IS test permits disease remission to be assessed more confidently.

Niels Pallisgaard, Zealand University Hospital.

Niels Pallisgaard, Zealand University Hospital.

“Bio-Rad’s ddPCR system is a powerful solution for monitoring patients treated for CML,” says Niels Pallisgaard, a molecular biologist in the department of pathology at Zealand University Hospital. “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.”

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 company’s QX200 ddPCR Dx system. The QXDx BCR-ABL %IS kit uses QuantaSoft software v1.7 for data acquisition and output.

For more information, visit Bio-Rad Laboratories.