Bio-Rad Laboratories Inc, Hercules, Calif, a life science research and clinical diagnostic products leader, recently announced that its QXDx AutoDG ddPCR system, which uses Bio-Rad’s droplet digital polymerase chain reaction (ddPCR) technology and the QXDx BCR-ABL %IS kit, are the company’s first digital PCR products to receive FDA clearance. Used together, Bio-Rad’s system and kit can precisely and reproducibly monitor molecular response to treatment among patients with chronic myeloid leukemia (CML).

“Bio-Rad is proud to announce our first FDA-cleared liquid biopsy test in oncology,” says Annette Tumolo, Bio-Rad executive vice president and president of the company’s 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.”

Annette Tumolo

Annette Tumolo, Bio-Rad Laboratories.

CML is a cancer of white blood cells that is characterized by a fusion of the BCR and ABL genes. For many patients, the availability of tyrosine kinase inhibitor (TKI) therapy has transformed CML into a manageable chronic disease. 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, offering physicians better insight into the management of this disease.

The QXDx AutoDG ddPCR system is designed to be flexible, allowing users to select the platform for performing either FDA-cleared in vitro diagnostics or lab-developed tests.

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 company’s 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.

For further information, visit Bio-Rad.

Featured image: The QXDx BCR-ABL %IS kit by Bio-Rad Laboratories.