Standardized BCR-ABL Molecular Diagnostics Test

Clinical Utility: Test that monitors treatment efficiency, Minimal Residual Disease (MRD) and follow-up for disease relapse.
Intended For: Chronic Myeloid Leukemia (CML) patients previously diagnosed with a BCR-ABL Mbcr fusion gene event
Prescribed By: oncologists
Performed In: Multiple CLIA laboratories
current status: pursuing FDA approval

CML is a blood-based malignant disease defined by the presence of the Philadelphia (Ph) Chromosome in the leukemic cells as a result of a translocation between chromosomes 9 and 22 t(9;22). The Ph+ cells harbor a fusion oncogene known as BCR-ABL. The gene encodes the fusion protein known as p210BCR-ABL which leads to deregulated tyrosine kinase activity and cellular proliferation.