Reference Standards for Tumor Profiling Analysis

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LGC SeraCare is the industry leader in NGS-based Reference Standards

LGC SeraCare’s portfolio of Seraseq® oncology reference products are industry standards for use in a broad range of NGS-based tumor profiling and immuno-oncology (I-O) assay workflows (see, e.g., Figure-1), used in disease diagnosis and I-O treatment outcome decisions. We offer RNA and DNA-based reference standards, in all formats (purified gDNA, RNA and FFPE) for use as positive sample controls in all phases of NGS assay needs – development, validation and clinical applications.

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Figure-1: A sample-to-report workflow for targeted NGS assays and applications of Seraseq controls for ensuring assay quality and accuracy of test results.

DNA Standards

Developing and optimizing somatic mutation assays is a difficult task, with variations in the amount of tumor cellularity and potential sources of variability across the NGS workflow. Successful assays require accuracy throughout the entire process, from sample DNA purification and quantitation, to library construction and template preparation, through bioinformatics parameters and variant annotation. 

Seraseq's DNA products offer mutation analysis of 40 clinically-relevant variants (SNVs, INDEL, SVs) blended at AF7% and AF10% in a single reference sample (see Figure-2). We also offer DNA reference standards for analyzing CNV amplifications of clinical relevance in some cancer diseases.

List of DNA genes

AKT1 CTNNB1 FLT3 GNAS KRAS NRAS/CSDE1 RET
APC EGFR FOXL2 IDH1 MPL PDGFRA SMAD4
ATM ERBB2 GNA11 JAK2 NCOA4-RET PIK3CA TP53
BRAF FGFR3 GNAQ KIT NPM1 PTEN TPR-ALK



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Seraseq Solid Tumor DNA Products
Seraseq Tumor Mutation DNA Mix v2 AF 10 HC Seraseq Lung & Brain CNV Mix, + 6 copies
Seraseq Tumor Mutation DNA Mix v2 AF 7 HC Seraseq Lung & Brain CNV Mix, + 12 copies
Seraseq Tri-Level Tumor Mutation DNA Mix v2 Seraseq Breast CNV Mix, + 3 copies
Seraseq FFPE WT (DNA/FNA) Reference Material Seraseq Breast CNV Mix, + 6 copies
Seraseq Lung & Brain CNV Mix, + 3 copies Seraseq Breast CNV Mix, + 12 copies

 

Contact us to learn more about our DNA Products

RNA Standards

LGC SeraCare has developed the most comprehensive panel of highly multiplexed Seraseq Fusion RNA reference materials to match these new highly muliplexed targeted RNA-based NGS assays. These products are offered in both a purified RNA format for ease of use in evaluating library preparation and sequencing, as well as a full-process FFPE reference material to assess performance starting with pre-analytical steps.

List of RNA fusion genes

CCDC6-RET FGFR3-BAIAP2L1 PAX8-PPARG1 IRF2BP2-NTRK1 PAN3-NTRK2
CD74-ROS1 FGFR3-TACC3 SLC34A2-ROS1 SQSTM1-NTRK1 BTBD1-NTRK3
EGFR Variant III KIF5B-RET SLC45A3-BRAF AFAP1-NTRK2  
EGFR-SEPT14 LMNA-NTRK1 TFG-NTRK1 NACC2-NTRK2  
EML4-ALK MET ex14 Skipping TMPRSS2-ERG QKI-NTRK2  
ETV6-NTRK3 NCOA4-RET TPM3-NTRK1* TRIM24-NTRK2  

 

RNA-Unique-Reads

For more on RNA standards read our blog posts on: Multi-Lab FFPE Fusion and Multi-Lab Fusion RNA Mix assessments for NGS assays.

Seraseq Solid Tumor RNA Products
Seraseq® FFPE Tumor Fusion RNA v4 Reference Material
Seraseq® Fusion RNA Mix v4
Seraseq® FFPE NTRK Fusion RNA Reference Material

 

Contact us to learn more about our RNA Products

 

TMB Products 

LGC SeraCare’s industry-first TMB reference standards are derived from tumor-normal matched human cell lines, and characterized by whole exome sequencing (WES) and a TMB analysis pipeline to determine their empirical TMB scores (see Table-1). Developed in collaboration with industry experts and analyzed by a range of NGS targeted panels and analysis pipelines (see, e.g., Figure 4), these reference standards provide ground-truth information for accurate determination of cancer patient TMB scores.

Table-1: Seraseq TMB reference standards and WES-derived TMB scores

Products

TMB Scores* (gDNA)

TMB Scores* (FFPE)
Seraseq® TMB Score 7 7.2 ± 0.2 7.15 ± 0.4
Seraseq® TMB Score 9 9.5 ± 0.4 7.52 ± 1.3
Seraseq® TMB Score 13  NEW! 12.6 ± 0.02 12.1 ± 0.3
Seraseq® TMB Score 20 20.1 ± 0.2 18.59 ± 0.5
Seraseq® TMB Score 26 25.8 ± 0.5 22.8 ± 3.6

 

 

 


*Based on Whole Exome Sequencing (WES)


NGS-based-TMB-Scores

  

Please contact us to learn more about our early access blood TMB (bTMB) and Micro-Satellite Instability (MSI) reference standards

 

Scientific Resources

To support our commitment and value we have selected assets we hope you find valuable. CLICK HERE to download some of the scientific content for our Seraseq® tumor profiling and immuno-oncology reference standards. After completing the form, you will receive an email with a link to all downloads.

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