IVD Assay Development

Seraseq® FFPE Tumor Fusion RNA v4 Reference Material

Material Number 0710-0496
Size 1 x 10 µm
Inventory Status In Stock
Unit EA

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.

Seraseq Certificate of AnalysisFFPE Fusion RNA Reference Mat

Doc type
Certificate of Analysis
Lot #
10566485

Certificate of AnalysisFFPE Fusion RNA Reference Mat

Doc type
Certificate of Analysis
Lot #
10528033

Seraseq FFPE Fusion RNA Reference Material v4

Doc type
Certificate of Analysis
Lot #
10430469

Seraseq FFPE Fusion RNA Reference Material v4

Doc type
Certificate of Analysis
Lot #
10544638

Seraseq FFPE Fusion RNA Reference Material v4

Doc type
Certificate of Analysis
Lot #
10430470

Seraseq FFPE Fusion RNA Reference Mat

Doc type
Certificate of Analysis
Lot #
10456407

Seraseq FFPE Fusion RNA Reference Mat

Doc type
Certificate of Analysis
Lot #
10456409

Seraseq FFPE Fusion RNA Reference Material v4

Doc type
Certificate of Analysis
Lot #
10633066

Seraseq FFPE Fusion RNA Reference Material v4

Doc type
Certificate of Analysis
Lot #
10621247

Seraseq FFPE Fusion RNA Reference Material v4

Doc type
Certificate of Analysis
Lot #
10682596

Seraseq FFPE Fusion RNA Reference Material v4

Doc type
Certificate of Analysis
Lot #
10610614

Seraseq FFPE Fusion RNA Reference Material v4

Doc type
Certificate of Analysis
Lot #
10690782

Seraseq FFPE Fusion RNA Reference Material v4

Doc type
Certificate of Analysis
Lot #
10705099

Seraseq Certificate of AnalysisFFPE Fusion RNA Reference Mat

Doc type
Certificate of Analysis
Lot #
10510041

Seraseq FFPE Fusion RNA Reference Material v4

Doc type
Certificate of Analysis
Lot #
10430471

Seraseq FFPE Fusion RNA Reference Mat

Doc type
Certificate of Analysis
Lot #
10456408

Seraseq FFPE Fusion RNA Reference Mat

Doc type
Certificate of Analysis
Lot #
10496536

Seraseq FFPE Fusion RNA Reference Material v4

Doc type
Certificate of Analysis
Lot #
10643075

Seraseq FFPE Fusion RNA Reference Material v4

Doc type
Certificate of Analysis
Lot #
10587339

Seraseq FFPE Fusion RNA Reference Material v4

Doc type
Certificate of Analysis
Lot #
10659791

Seraseq FFPE Fusion RNA v4 Reference Material

Doc type
Package Insert

Seraseq Fusion RNA Reference Materials

Doc type
Product Sheet

Seraseq FFPE Safety Data Sheet

Doc type
Safety Data Sheet

Technical Spreadsheet for Seraseq Tumor Fusion RNA v4 Reference Materials

Doc type
Technical Spreadsheet
Product Specifications
# of Fusions 18
Size 10 µm
Format FFPE
RNA Yield* >400 ng

*From 1x10 µm FFPE curl using QIAGEN AllPrep DNA/RNA Prep kit/Qubit RNA HS quant

Solid Tumor FAQs

Review the common questions we receive from our customers and the responses we provide.

LEARN MORE