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Bio-Rad Releases First FDA-Cleared Digital PCR System and Test for Monitoring Chronic Myeloid Leukemia Treatment Response

BIO | February 14, 2019

Bio-Rad Releases First FDA-Cleared Digital PCR System and Test for Monitoring Chronic Myeloid Leukemia Treatment Response

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that its QXDx AutoDG ddPCR System, which uses Bio-Rad’s Droplet Digital PCR technology, and the QXDx BCR-ABL %IS Kit are the industry’s first digital PCR products to receive U.S. Food and Drug Administration (FDA) clearance. Used together, Bio-Rad’s system and kit can precisely and reproducibly monitor molecular response to treatment in patients with chronic myeloid leukemia (CML).

“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, offering physicians better insight into the management of this disease.

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.

Bio-Rad, Droplet Digital, ddPCR, and QuantaSoft are trademarks of Bio-Rad Laboratories, Inc. in certain jurisdictions

About Bio-Rad

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) is a global leader in developing, manufacturing, and marketing a broad range of innovative products for the life science research and clinical diagnostic markets. With a focus on quality and customer service for over 65 years, our products advance the discovery process and improve healthcare. Our customers are university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality. Founded in 1952, Bio-Rad is based in Hercules, California, and has a global network of operations with more than 8,000 employees worldwide. Bio-Rad had revenues exceeding $2.1 billion in 2017. For more information, please visit www.bio-rad.com.

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