Seraseq® Tumor Mutation DNA Mix v3 AF10%

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 AF10% reference material represents one of our most complex products to date, containing the highest number of biosynthetic variants in a single mix. It is specifically designed to support NGS assay development, validation, and routine QC monitoring.

Seraseq® Tumor Mutation Mix DNA v3 AF10% contains 112 variants across 92 genes, including key tumor suppressors, oncogenes, DNA repair and cell cycle regulators. These biosynthetic variants are blended into a well-characterized GM24385 background. 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 
• All variants are targeted at a VAF of 10% and CNVs at +12 copies

• Mutation targets quantified by highly sensitive 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