“Bio-Rad is proud to announce our first FDA-cleared liquid biopsy test in oncology,” said 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 leukemia under tyrosine kinase inhibitor therapy.”
CML is a cancer of white blood cells that is characterized by a fusion of the BCR and ABL genes. Tyrosine kinase inhibitor (TKI) therapy has transformed CML into a manageable chronic disease for many patients. The current standard for monitoring treatment response in patients with CML is using reverse transcription quantitative PCR (RT-qPCR), but this method can produce variable results, particularly when measuring low levels of the disease. Using the QXDx BCR-ABL %IS Kit, clinicians can accurately and reproducibly monitor residual disease in patients with CML, even at low levels, ...