Skip to main content

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).

Brought to you byBio-Rad Laboratories
| 1 min read

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

“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?
Add The Scientist as a preferred source on Google

Add The Scientist as a preferred Google source to see more of our trusted coverage.

Related articles background image
The Scientist Digest cover September 2026
September 2026

Multiplex Microscopy Becomes Easier with Encoded Antibodies

A new system that enables researchers to uniquely tag monoclonal antibodies for use in microscopy could help simplify complex imaging studies.

View this Issue
Rethinking ALS Biomarkers: From Discovery to Clinical Impact

Rethinking ALS Biomarkers: From Discovery to Clinical Impact

Alamar Biosciences logo
Best Practices for qPCR Assay Design and Optimization

Best Practices for qPCR Assay Design and Optimization

Bio-Rad
Beyond the Basics: Strategies for Single-Cell and Spatial Transcriptomics Analysis

Beyond the Basics: Strategies for Single-Cell and Spatial Transcriptomics Analysis

bioxcell
Scientist reviewing cellular and molecular data on a computer in a laboratory.

Building Translation-Ready Biomarkers with Connected Workflows

Danaher Logo

Products

Closeup image of a multi channel pipette dispensing pink liquid into a 96-well plate.

The ASSIST PLUS pipetting robot for affordable workflow automation

Integra Logo
Single cells in suspension

Rapidly isolate primary cells and make uniform single-cell suspensions with Corning® Cell Strainers

Corning logo
Abstract image representing cell membranes linked together.

CellBrite® Steady Membrane Stain: Cell surface staining built for real-time imaging

Biotium
sino biological logo

Monod Bio Licenses AI-designed Protein Technologies to SignalChem Biotech for Custom Discovery Assays