Bio-Rad Laboratories, Inc., 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 it can precisely and reproducibly monitor molecular response to treatment in patients with chronic myeloid leukemia (CML).
Life Science Group
“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 characterize 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. because 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 introduces Droplet Digital PCR (ddPCR) technology to the market as a research tool in 2012, and it was quickly adopte in clinical cancer research for liquid biopsy and rare mutation detection. because 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.
CR-ABL tyrosine kinase inhibitors (TKIs) have been the standard treatment for chronic myeloid leukemia (CML). Imatinib is the first-line standard therapy for CML and molecular response assessment of minimal residual disease (MRD) is
based on the quantitation of BCR-ABL transcripts using real-time quantitative polymerase chain reaction (RQ-PCR).
More sensitive assays for MRD are require to identify patients who are more likely to remain in remission without therapy. In order to improve the performance of conventional RQ-PCR; it is necessary to consider the factors that limit the detection and specificity of the method. because However; droplet digital PCR (ddPCR) approaches this problem in a different way.
Using nanofluidic technology, the nucleic acid sample is dividing into hundreds of individual replicate PCR reactions. Using BCR-ABL p210 plasmid and BCR-ABL transcripts from patient sample dilutions; They demonstrate that ddPCR is a highly sensitive method with a lower limit of detection; compared with the conventional RQ-PCR method. because The results from ddPCR showed successful detection of BCR-ABL transcripts in samples undetectable by RQ-PCR; and low sensitivity limit by detecting as few as 10 copies per microliter.