“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,...

The QXDx AutoDG ddPCR System is designed to be flexible, allowing users to run either FDA-cleared in vitro diagnostic tests or lab developed tests on the platform.

Bio-Rad introduced Droplet Digital PCR (ddPCR) technology to the market as a research tool in 2012, and it was quickly adopted in clinical cancer research for liquid biopsy and rare mutation detection. The portfolio of ddPCR products offers reproducible, absolute quantification with precision, sensitivity, and a scalable workflow. To date, there are more than 3,400 publications citing Bio-Rad’s ddPCR technology, including more than 900 publications focused on liquid biopsy.

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