Seraseq® FFPE Tumor Fusion RNA v4 Reference Material

As the diagnostic testing paradigm for chromosomal translocations and other complex structural variants continues to shift from single-site Fluorescent In Situ Hybridization (FISH) and targeted RT-PCR to highly multiplexed next-generation sequencing (NGS) assays, there is increasing need for highly multiplexed reference materials for these difficult mutations.

The Seraseq FFPE Tumor Fusion RNA Reference Material v4 contains 18 clinically significant RNA fusions which are prevalent across different types of solid tumors, in an efficient single-sample format. RNA transcripts carrying structural variants are engineered into well-characterized wild-type cells. Cells are formalin-fixed and embedded in paraffin, and the FFPE block is cut into 10-micron sections, each of which typically yields >400 ng of purified total RNA. The transcript level for each fusion is quantified using highly sensitive digital PCR to establish ground-truth (and orthogonally validated with NGS), which helps ensure the material remains constant over time.

• 18 clinically relevant fusions evaluate assay sensitivity and specificity for important diagnostic, prognostic, and therapeutic targets
• Full-process FFPE format may be treated like a clinical specimen, which can reveal pre-analytic variability
• Quantification of transcript levels by dPCR establishes ground-truth and simplifies dilutions for Limit of Detection (LoD) experiments
• Well-characterized GM24385 human genomic DNA as background wild-type material
• Manufactured in GMP-compliant and ISO 13485-certified facilities

For research use only. Not for use in diagnostic procedures.

Specifications

Documents

• Seraseq Fusion RNA Reference Materials (Product Sheet)
• Seraseq FFPE Fusion RNA v4 Reference Material (Package Insert)
• Technical Spreadsheet for Seraseq Tumor Fusion RNA v4 Reference Materials (Technical Spreadsheet)
• Seraseq FFPE Safety Data Sheet (Safety Data Sheet)

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