Performance Characteristics Of The First FDA-Cleared Droplet Digital PCR (ddPCR) IVD Assay For Monitoring Chronic Myelogenous Leukemia (CML)

By Nathan Sepulveda, Prasanthi Bhagavatula, Lan Beppu, Jerald Radich, and Dawne N Shelton

Chronic myelogenous leukemia (CML) is a cancer of myeloid cells that accounts for 15-20% of all cases of leukemia. Most CML cases are caused by a translocation between chromosomes 9 and 22 that creates an abnormal fusion gene, BCR-ABL1. The BCR-ABL1 gene expresses an abnormal tyrosine kinase protein that causes unregulated growth and survival of granulocytes. CML is treated with TKIs (tyrosine kinase inhibitors). The concentration of BCRABL1 transcript RNAs is a marker of disease progression and the effectiveness of TKI treatment.

Bio-Rad’s QXDx™ BCR-ABL %IS Kit quantifies the amount of BCR-ABL1 transcript as a ratio of BCR-ABL1/ABL1, then returns the value of Molecular Response (MR) and on the WHO International Scale(IS). The QXDx software performs automatic data analysis and reporting, results are reported in %IS, MR, and copies values.