Reference Materials – The Foundation for Reliable Diagnostics

Standardized. Reproducible. Comparable.
Our cfDNA reference materials enable standardized verification of analytical procedures, validation of diagnostic tests, and reliable interpretation of results. Particularly in highly sensitive applications such as liquid biopsy, they are essential for accurately assessing performance characteristics such as sensitivity, specificity, detection limits, and reproducibility under practical conditions. As stable, biologically relevant control samples, they ensure the comparability of diagnostic processes across time, laboratories, and methods.

Validation and Method Comparison in Collaboration with QuoData

CEBIO collaborates with its partner QuoData in conducting interlaboratory comparisons. This innovative study concept was developed by QuoData in cooperation with the U.S. FDA. Regularly performed interlaboratory comparisons serve both the validation and comparison of different methods and assays as well as the assessment of laboratory performance and conformity. All interlaboratory comparisons are based on wild-type materials that reflect the natural variability of samples under real laboratory conditions.

Do you operate a liquid biopsy laboratory?

You are warmly invited to participate in our interlaboratory comparisons for a small participation fee.

CEBIO develops cell line–based cfDNA reference materials — standardized and practice-oriented.

In cooperation with specialized partners, CEBIO produces high-quality, cell-based reference materials for circulating free DNA (cfDNA). These materials are tailored to the requirements of modern liquid biopsy applications — from method development and validation processes to routine quality assurance.

Production is based on defined human cell lines. Both wild-type and tumor-specific cfDNA reference materials are generated, featuring authentic biological and molecular characteristics.

Quality Characterization Includes:

Fluorometric quantification
Fragment size analysis via Bioanalyzer 2100 and TapeStation
dPCR and NGS for mutation analyses (e.g., SNVs)
Homogeneity and stability testing

Applications and Diagnostic Utility

CEBIO reference materials are used for:

Development and validation of new liquid biopsy assays
Quality assurance in routine laboratory practice
External quality assessment (ring trials)
Device and platform comparisons
Studies of detection limits, specificity, and robustness of molecular assays

Key Advantages for Research and Diagnostics at a Glance

Biological authenticity – cfDNA with realistic fragment size distributions, derived from cultured tumor cell lines
Standardization – production according to defined protocols
Reproducibility – consistent results, ideal for longitudinal and multi-center studies
Stability & practical applicability – tested under real transport, storage, and application conditions
Flexibility – customized variants with specific SNVs

Overall Benefits at a Glance

Benefit	Description
Biological authenticity	cfDNA from tumor cell lines with natural fragment sizes and signatures
Reproducibility	Standardized materials enable consistent results, even in long-term and multi-center studies
Flexible customization	Tailored variants for optimizing specific research questions
Innovative diversity	Different fragmentation patterns and mutation profiles
Efficiency & scalability	Processes designed for both small-scale research and larger routine applications

Why CEBIO?

CEBIO combines extensive experience in the production of cell-based cfDNA reference materials with deep methodological expertise in validation, clinical relevance assessment, and quality assurance. Our products provide a reliable foundation for research, diagnostics, and innovative liquid biopsy applications. We work closely with QuoData, whose expertise in statistics, ring trial design, and methodological evaluation makes a key contribution to the quality and reproducibility of our materials.

We work closely with QuoData, whose expertise in statistics, ring trial design, and methodological evaluation makes a key contribution to the quality and reproducibility of our materials.

Reference Materials for Liquid Biopsy – Consultation & Distribution

Do you need reference materials for the validation of your liquid biopsy assays or are you looking for a customized solution?
Our experts will be happy to advise you personally and support you in selecting suitable products as well as in individual customization.

Unsere Produkte sind über unseren Vertriebspartner new_diagnostics erhältlich, der Sie auch bei Bestellung, Lieferung und technischen Rückfragen kompetent begleitet: