Strength of ddPCR™ Products, Including IVDR Certification, Strategic Collaborations in Molecular Residual Disease Monitoring, and Large Methylation Assay Library, Support Company’s Oncology Strategy
HERCULES, Calif. — November 12, 2024 — Bio-Rad Laboratories, Inc., a global leader in life science research and clinical diagnostics products, announces updates on its oncology assay portfolio and regulatory milestones, ahead of its presence at the AMP 2024 meeting. Centered around improving patient outcomes through cancer biomarker detection, and based on Bio-Rad’s Droplet Digital™ PCR (ddPCR™) technology, updates include achieving IVDR Class C certification for its QXDx BCR-ABL %IS Kit (IVD/CE-IVD), to monitor patients with Chronic Myeloid Leukemia (CML), as well as strategic collaborations with leaders in the fields of molecular residual disease (MRD) detection and circulating tumor DNA (ctDNA) analysis in oncology.
Products to Support the Adoption of Droplet Digital PCR in Oncology
In a key regulatory milestone, Bio-Rad has obtained In Vitro Diagnostic Regulation (IVDR) certification for its ddPCR QXDx BCR-ABL test in Europe by the notified body GMED (0459). Reporting in both International Scale (%IS) and Molecular Response (MR) values, the QXDx BCR-ABL %IS Kit monitors the p210 BCR-ABL major translocation in the peripheral blood of patients with CML. The test is the first FDA-cleared CML monitoring assay for BCR-ABL designed to run on Bio-Rad's QXDx ddPCR System, enabling laboratories with precise, highly sensitive, direct absolute quantification of nucleic acids. Monitoring of BCR-ABL transcript levels gives an indication of leukemic inhibition throughout treatment in CML patients.
In July 2024, Bio-Rad launched more than 50 new ddPCR Methylation Detection Assays, available on the Company’s Digital Assays portal, designed to provide more precise and reliable detection of methylation markers that are critical tools in the research of early diagnosis and monitoring of various cancers. This builds upon Bio-Rad’s extensive library of thousands of oncology-specific assays developed for Droplet Digital PCR, which have supported hundreds of published peer-reviewed studies, supporting the Company’s strategy to help advance oncology research.
Collaborations Leveraging Droplet Digital PCR
MRD monitoring of cancer provides an indication of both remission and potential relapse and is being increasingly adopted for the monitoring of solid tumors. Bio-Rad is collaborating with Allegheny Health Network (AHN), an integrated health network with 14 hospitals, in an observational study using ddPCR for tumor-informed MRD monitoring in patients with solid-tumor cancer following curative-intent treatment. Bio-Rad’s QX600™ ddPCR System offers investigators unmatched sensitivity, precision, and absolute quantification capabilities, and can be used to detect disease markers, such as ctDNA, earlier and more precisely than other commonly used technologies. Bio-Rad is also collaborating with the Department of Molecular Medicine (MOMA) at Aarhus University Hospital in Denmark, to generate evidence for MRD monitoring post curative-intent treatment in patients with colorectal cancer.
Under a longstanding collaboration between Bio-Rad and Biodesix, a diagnostics solutions company with a focus on lung diseases, novel, highly multiplexed ddPCR oncology assays are being developed for future commercialization. Biodesix recently announced its use of ddPCR in the evolution of its collaborative research agreement with the Memorial Sloan Kettering Cancer Center, driving forward advancements in cancer diagnostics and treatment. Droplet Digital PCR performed at Biodesix was recently featured in two publications, in The New England Journal of Medicine, and Annals of Oncology, related to Johnson and Johnson’s MARIPOSA non-small-cell lung cancer trial, where it was used to measure cancer mutations in participating patient samples.
Bio-Rad will host thought-leaders from these collaborating organizations at its workshop at AMP 2024 focusing on MRD and Droplet Digital PCR. Hosted by Dr. Prithwish Pal, Director, Global Product Marketing, Oncology at Bio-Rad, both Dr. William LaFramboise, Chief Genomics Technology Officer at AHN, and Dr. Gary Pestano, Chief Development Officer at Biodesix, Inc., will discuss their work in the development of highly sensitive mutation detection and ctDNA analysis assays. Discussions will include how these applications are changing the field of MRD detection in oncology and why Droplet Digital PCR, which affords high precision along with a cost-effective, user-friendly workflow, has been critical to their work.
“Bio-Rad continues to build its leadership position in the oncology market,” said Steve Kulisch, Vice President Product Management, Digital Biology Group, Bio-Rad Laboratories. “We are extremely proud that our BCR-ABL assay has already obtained IVDR certification, alongside key product launches earlier in the year including the first ultrasensitive multiplexed digital PCR assay for breast cancer mutation detection in clinical research, the ddPLEX ESR1 Mutation Detection Kit.” He continues: “We are accelerating further progress through our strategic collaborations outlined above, and through our involvement in high-profile consortia, such as BloodPAC and the FNIH Biomarkers consortium. We are justifiably extremely proud of our progress in this vital area of science and look forward to meeting with our colleagues in the oncology field at AMP.”
To learn more about Bio-Rad’s QXDx BCR-ABL %IS Kit, visit bio-rad.com/IVDR/BCR-ABL.
