Global life science researcher Bio-Rad has announced that its droplet digital PCR-based test for chronic myeloid leukaemia (CML), the first of its kind, has been cleared by the FDA. The test quantifies BCR-ABL, the gene fusion which causes CML, in a patient’s blood.

CML is a cancer of the white blood cells where the BCR and ABL genes fuse. The diseases is manageable in some patients by tyrosine kinase inhibitor (TKI) therapy. Currently, the standard for monitoring treatment response is using reverse transcription quantitative PCR (RT-qPCR). This method produces a range of responses, however, particularly when measuring the disease at low levels.

Bio-Rad’s QXDx AutoDG ddPCR System lets users run either FDA-approved in vitro diagnostic tests or lab-developed tests on the platform. Though no criteria has been established to determine when therapy can stop, the detection of low BCR-ABL levels might be able to help physicians give patients the best treatment possible.

According to Annette Tumolo, Bio-Rad EVP and President, Life Science Group: “The QXDx AutoDG ddPCR System and QXDx BCR-ABL %IS Kit represent the first-ever digital PCR solution that can monitor and directly quantitate the molecular response of patients with chronic myeloid leukaemia under tyrosine kinase inhibitor therapy.”