Bio-Rad Launches First FDA-Approved Digital PCR System for Monitoring Molecular Response in Chronic Myeloid Leukemia Therapy

VCBeat (WeChat ID: biobeat1) has learned that on February 14, 2019, Bio-Rad Laboratories, Inc. (NYSE: BIO), a global leader in life science research and clinical diagnostic products, announced that its QXDx AutoDG ddPCR System and QXDx BCR-ABL %IS Kit had become the first digital PCR products to receive approval from the U.S. Food and Drug Administration (FDA).

The QXDx AutoDG ddPCR System utilizes Bio-Rad’s Droplet Digital PCR technology. When used in conjunction with Bio-Rad’s systems and kits, it enables precise and reproducible monitoring of molecular response to therapy in patients with chronic myeloid leukemia (CML).

“Bio-Rad is proud to announce our first FDA-approved liquid biopsy test in the field of oncology,” said Annette Tumolo, Executive Vice President and President of the Life Science Group at Bio-Rad. “The QXDx AutoDG ddPCR System and the QXDx BCR-ABL %IS Kit are the first digital PCR solutions available for monitoring and directly quantifying molecular responses in patients with chronic myeloid leukemia undergoing tyrosine kinase inhibitor therapy.”

CML is a leukemia of white blood cells, characterized by the fusion of the BCR and ABL genes. Tyrosine kinase inhibitor (TKI) therapy has transformed CML into a treatable chronic condition for many patients. Currently, the standard for monitoring treatment response in CML patients is reverse transcription quantitative PCR (RT-qPCR). However, this method can yield unstable results, particularly when measuring low levels of disease. Using the QXDx BCR-ABL %IS Kit, clinicians can accurately and reproducibly monitor residual disease in CML patients, even at low levels, thereby enabling physicians to better understand the management of this disease.

The QXDx AutoDG ddPCR System features a flexible design, allowing users to run FDA-approved in vitro diagnostic tests or laboratory-developed tests on the platform.

Bio-Rad launched Droplet Digital PCR (ddPCR) technology as a research tool in 2012, and it was rapidly adopted in clinical cancer research for liquid biopsy and rare mutation detection. The ddPCR product portfolio delivers reproducible absolute quantification with precision, sensitivity, and scalable workflows. To date, Bio-Rad’s ddPCR technology has been cited in more than 3,400 publications, including over 900 focused on liquid biopsy.

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B) is a global leader in developing, manufacturing, and marketing a wide range of innovative products for the life science research and clinical diagnostics markets. For over 65 years, our focus on quality and customer service has accelerated the discovery process and improved healthcare. Our customers include universities and research institutions, hospitals, public health and commercial laboratories, as well as biotechnology and pharmaceutical companies and applied laboratories in fields such as food safety and environmental quality.

Bio-Rad was founded in 1952 and is headquartered in Hercules, California. It operates a global network with more than 8,000 employees worldwide. In 2017, Bio-Rad generated revenues exceeding $2.1 billion.