Quality Controls & Reference Materials for Oncology Assays

CD Genomics Oncology Nucleic Acid Quality Controls & Reference Products are dedicated to supporting the promise of precision oncology by enabling the analysis of operationally challenging genomic variations within patient samples. These patient-relevant reference materials facilitate the development, validation, and implementation of next-generation sequencing (NGS) and PCR-based assays for cancer research, therapeutic monitoring, and patient stratification.

Controls and Reference Materials for Genomic Analysis in Cancer and Genetic Diseases


The execution of tumor analysis assays, whether based on NGS or PCR, is often hindered by the lack of reference samples that encompass the necessary breadth of relevant genomic alterations and similarity to patient specimens. CD Genomics oncology analysis reference and QC materials are highly multiplexed and rigorously validated, including ddPCR, combining well-characterized normal or tumor cell lines with engineered biological variants. They meet the demands of targeted DNA and RNA sequencing analysis, providing high-quality QC products for various sample types, including liquid biopsies (cancer ctDNA) and FFPE samples. Our goal is to expedite the clinical application of NGS and PCR technologies in diagnosis, treatment, and management across various cancer types.

Our Product Portfolio

  • Genomic DNA (gDNA) QC: Single nucleotide variants (SNVs), insertions and deletions (INDELs), copy number variations (CNVs), structural variations (SVs), and wild types.
  • Circulating Tumor DNA (ctDNA) for liquid biopsy QC: Purified ctDNA and plasma-encapsulated ctDNA, allowing laboratories to validate and optimize the detection of cancer-associated mutations in minimal amounts of circulating tumor DNA.
  • Formalin-Fixed Paraffin-Embedded (FFPE) QC: Ensure the accuracy of NGS assays on FFPE tissue, a crucial aspect of cancer diagnostics.
  • HRD Reference Products: Asses the genomic instability characteristic of certain cancer types. They are valuable tools for the development and quality control of HRD detection assays, important for precision medicine approaches.
  • Minimal Residual Disease (MRD) Reference Products: Monitor disease progression and treatment response. They enable the validation and calibration of assays aimed at detecting minimal levels of residual cancer cells in patient samples.
  • Homologous Recombination Repair (HRR) Reference Products: These materials are specifically designed to support the evaluation of homologous recombination repair deficiency in cancer. They assist in the development and validation of assays for identifying patients who may benefit from specific therapies.
  • Tumor Mutation Burden (TMB) Reference Products: TMB is an emerging biomarker for immunotherapy response prediction. Our TMB reference materials aid in the standardization of TMB assessment across laboratories, ensuring consistent and reliable results.
  • Microsatellite Instability (MSI) Reference Products: MSI is another crucial biomarker in immuno-oncology. Our MSI reference materials facilitate the accurate detection and interpretation of MSI status in cancer samples.
  • Copy Number Variation (CNV) Reference Products: CNVs play a significant role in cancer development. Our CNV reference materials assist in the calibration and quality control of CNV detection assays.

Key Features and Benefits

  • Accurate simulation of real patient samples.
  • Reduced troubleshooting time.
  • Enhanced consistency in assay performance.
  • Increased confidence in results.
  • Available in various forms (purified nucleic acids [DNA, RNA, or circulating tumor DNA (ctDNA)], plasma-encapsulated ctDNA, or FFPE).
  • Inclusive of all mutation types: SNV, INDEL, CNV, SV, RNA fusion, and complex genomic features.
  • Compliant with GMP requirements.

Our quality control materials offer versatile solutions for oncology applications, including the analysis of solid tumors, hematological diseases, immune oncology, and liquid biopsies.


What do oncology nucleic acid quality control materials entail?

Oncology nucleic acid quality control materials serve as essential reference substances employed to evaluate and guarantee the precision and reliability of DNA and RNA specimens for oncology assessments. These quality control materials commonly feature well-defined DNA or RNA sequences, playing a crucial role in validating the exactness and consistency of a laboratory's sequencing and analytical procedures.

Why is the use of dependable DNA/RNA quality control materials of paramount importance in oncology testing?

  • Ensuring Data Precision: Quality control (QC) materials play a pivotal role in validating the precision of sequencing data, thereby guaranteeing the credibility and accuracy of analytical outcomes.
  • Facilitating Experimental Consistency: QC materials are instrumental in standardizing experimental results, promoting comparability across various laboratories, and maintaining uniformity in data generation.
  • Aiding in Problem Identification: These QC materials serve as invaluable tools for promptly identifying and troubleshooting potential issues within the experimental process, especially in cases where sequencing data presents anomalies or irregularities.
  • Enhancing Data Interpretation: The inclusion of QC materials provides a valuable framework for elucidating the correlation between potential biological disparities and variations arising from distinct experimental methodologies.

What technologies can be employed to guarantee the precision of sequencing data?

  • QC Samples: Employ well-characterized standard samples to validate the precision and uniformity of sequencing.
  • QC Metrics: Implement quality control metrics for continuous monitoring of sequencing data, encompassing parameters like sequencing depth and base quality scores.
  • Quality Assurance Protocols: Laboratories can establish robust quality assurance protocols, encompassing sample handling, maintenance of sequencing instruments, and rigorous data analysis, all designed to uphold the integrity of the data.
  • Sample Reproducibility: Validate the consistency of results by resequencing samples, ensuring the reliability and repeatability of the obtained data.

How can laboratories optimize their strategies for ensuring the quality of sequencing processes?

Quality Control (QC) and Reference Standards: Laboratories routinely rely on Quality Control (QC) measures and reference materials to assess and validate the integrity of their sequencing procedures. QC samples feature well-established sequences and serve as benchmarks for assessing sequencer performance, while reference materials encompass samples with known characteristics used to confirm the precision and reliability of the experimental workflow. By performing comparative analyses against these reference samples, potential issues can be identified and rectified promptly, thereby safeguarding the credibility of sequencing outcomes.

What are the current shortcomings in oncology quality control testing?

  • Sample Diversity Complexity: The extensive diversity of tumor samples poses a multifaceted challenge to quality control (QC) processes, necessitating the development of a broader range of QC criteria to accommodate the diverse array of tumor types.
  • Standardization Dilemmas: Achieving standardization in oncology testing remains a persistent hurdle, with laboratories often employing disparate QC methodologies, undermining the uniformity and reliability of results.
  • Sensitivity Limitations: Some QC techniques exhibit limitations in their ability to detect low-frequency variants or accurately measure tumor markers at low concentrations, raising concerns about their efficacy in certain clinical scenarios.

What are the new quality control solutions available?

Liquid biomarkers, including liquid biomarker assays like liquid biopsies, offer non-invasive insights into tumor characteristics. However, there is an ongoing quest to enhance their precision and sensitivity.

Deep Learning and Artificial Intelligence: The utilization of deep learning and artificial intelligence techniques has become indispensable for scrutinizing sequencing data. These technologies play a pivotal role in identifying potential issues and elevating the overall quality of data.

Microfluidics: Microfluidics technology is transforming the landscape of sample handling in laboratories. It offers precision and accuracy, minimizing the scope for errors and elevating the quality of sequencing processes.

* For Research Use Only. Not for use in diagnostic procedures.
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