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

HERCULES, Calif.–(BUSINESS WIRE)–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

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Bio-Rad Laboratories, Inc.
Tina Cuccia, Corporate Communications

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