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).

Written byBio-Rad Laboratories
| 1 min read

Register for free to listen to this article
Listen with Speechify
0:00
1:00
Share

“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, ...

Interested in reading more?

Become a Member of

The Scientist Logo
Receive full access to more than 35 years of archives, as well as TS Digest, digital editions of The Scientist, feature stories, and much more!
Already a member? Login Here
Share
Illustration of a developing fetus surrounded by a clear fluid with a subtle yellow tinge, representing amniotic fluid.
January 2026

What Is the Amniotic Fluid Composed of?

The liquid world of fetal development provides a rich source of nutrition and protection tailored to meet the needs of the growing fetus.

View this Issue
Human-Relevant In Vitro Models Enable Predictive Drug Discovery

Advancing Drug Discovery with Complex Human In Vitro Models

Stemcell Technologies
Redefining Immunology Through Advanced Technologies

Redefining Immunology Through Advanced Technologies

Ensuring Regulatory Compliance in AAV Manufacturing with Analytical Ultracentrifugation

Ensuring Regulatory Compliance in AAV Manufacturing with Analytical Ultracentrifugation

Beckman Coulter Logo
Skip the Wait for Protein Stability Data with Aunty

Skip the Wait for Protein Stability Data with Aunty

Unchained Labs

Products

Sino Biological Logo

Sino Biological's Launch of SwiftFluo® TR-FRET Kits Pioneers a New Era in High-Throughout Kinase Inhibitor Screening

SPT Labtech Logo

SPT Labtech enables automated Twist Bioscience NGS library preparation workflows on SPT's firefly platform

nuclera logo

Nuclera eProtein Discovery System installed at leading Universities in Taiwan

Brandtech Logo

BRANDTECH Scientific Introduces the Transferpette® pro Micropipette: A New Twist on Comfort and Control