MRD Reference Standards – For Ultra-Low Frequency ctDNA Detection
40+ pathogenic variants across 30+ genes, validated down to 0.005% VAF for MRD research
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Product Introduce
CB-Gene’s Package-Ref™ MRD Cocktail Reference Standard is designed specifically for ultra-low frequency ctDNA detection. It contains 30+ genes and 40+ pathogenic/likely pathogenic variants, including SNVs, insertions, deletions, and fusions. Using optimized ddPCR with >6000 copies per well, we have precisely characterized variants at 0.5% VAF, with serial dilution validation down to 0.05% and 0.005% VAF – levels that simulate real-world MRD detection challenges (NSCLC requires stable detection of ≥0.02% ctDNA).
Product Advantages
Our HRD Reference Standards to ensure the accuracy and reproducibility of HRD testing in clinical diagnostics and research, standardized reference materials are essential.
40+ pathogenic variants
Across 30+ genes, all with clinical significance (Pathogenic/Likely Pathogenic).
Diverse mutation types
Includes SNVs, insertions, deletions, frameshift, in-frame, nonsense, missense, splice-site, and fusions.
Serial dilution ready
High-frequency anchor variants (e.g., BRAF V600E at 5%) enable accurate dilution factor verification for 0.05% and 0.005% levels.
Ultra-low frequency validation
ddPCR-characterized at 0.5% VAF; dilution-validated at 0.05% and 0.005% VAF.
High-copy ddPCR calibration
>6000 copies per well at 0.5% to distinguish true positives from LOB; >12,000 copies for ultra-low frequency validation.
Dual-route compatible
Suitable for both tumor-informed assays (personalized panels) and tumor-agnostic assays (fixed panels).
Application
MRD Assay Development
Ultra-Low Frequency LoD
Daily Quality Control
Company Advantage
Expertise in reference standards – CB-Gene specializes in oncology molecular diagnostics with ISO‑certified production and patented technology.
Scientific Quality Management
With our ISO9001 certification, we adhere to a stringent quality management system, ensuring that all our products meet the highest standards of accuracy, stability, and consistency.
Ultra-low frequency expertise
Proprietary ddPCR calibration protocols achieve robust characterization at 0.005% VAF.
Specialized in IVD reference standards
CB-Gene focuses on positive reference panels, LoD standards, and precision controls for diagnostic development.
40+ clinically relevant variants
All variants are pathogenic/likely pathogenic with clear pathological grading significance.
Customizable formats
Art-base and Nat-base options; gDNA, FFPE, or ctDNA formats available upon request.
Experienced and Skilled Team
Backed by a talented team of experts, we leverage advanced technology and extensive experience to drive innovation in molecular diagnostics, ensuring we stay at the forefront of the industry.
Dedicated technical support
Free pre- and post-sales assistance for assay integration and troubleshooting.
Comprehensive Product Range
We offer a complete set of reference materials, including SNP, Indel, CNV, Fusion, NIPT, and more, covering a wide array of diagnostic needs and offering customized services for a variety of applications.
Contact Us
We're here to assist you! Whether you have questions about our products, services, or need technical support, our team is ready to provide you with the information you need. Reach out to us today!
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