Seraseq® Tumor Mutation DNA Mix v3 Tri-Level

SeraCare continues to lead in providing innovative, fit-for-purpose reference standards to meet the evolving needs of NGS assays. The Seraseq® Tumor Mutation Mix DNA v3 Tri-Level reference material represents one of our most complex products to date, containing the highest number of biosynthetic variants in a single mix. Specifically designed to support NGS assay development, validation, and routine QC monitoring, this unique product offers a range of allele frequencies in a single sample format. 

Seraseq® Tumor Mutation Mix DNA v3 Tri-Level contains 112 biosynthetic variants across 92 genes - including key tumor suppressors, oncogenes, DNA repair and cell cycle regulators. These variants are blended into a well-characterized GM24385 background, with certain variants targeted at 4%, 7% and 10% allele frequency and +3, +6, or +12 copies.  This ready-to-use material is optimized for use in NGS workflows following DNA extraction through to downstream analysis. Manufactured under cGMP-compliant ISO 13485-certified facilities, this reference material ensures lot-to-lot consistency and accuracy, ultimately supporting high-quality genomic testing outcomes.  

FEATURES and BENEFITS  

• 112 unique multiplexed biosynthetic DNA variants across 92 genes in a single reference material  
  • 51 SNVs
  • 39 Indels
  • 10 Translocations
  • 12 CNVs
• 94 variants recognized as FDA drug targets support comprehensive detection of clinically actionable mutations 
• Allele frequencies are distributed at 4%, 7% and 10%, and CNVs at +3, +6, or +12 copies

• Mutation targets quantified with digital PCR and orthogonally validated by NGS 

• Blended with well-characterized GM24385 human genomic DNA as background wildtype material 
• Support assay validation studies including determination of assay sensitivity, specificity and Limit of Detection (LoD)
• Manufactured under cGMP-compliance and ISO 13485-certified facilities