Controls & Reference Materials

Seraseq® FFPE Tumor Fusion RNA Reference Material v2

Material Number 0710-0129
Size 1 x 1 FFPE curl
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.

Seraseq FFPE Tumor Fusion RNA Reference Material v2 contains 16 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 at least 400 nanograms of RNA. The transcript level for each fusion is quantified using highly sensitive digital PCR to establish ground-truth, which helps ensure the material remains constant over time.

  • 16 clinically relevant fusions evaluate assay sensitivity and specificity for important diagnostic, prognostic, and therapeutic targets
  • Multiplexing of mutations saves time and cost by generating the most information in a single run
  • Full-process FFPE format may be treated like a clinical specimen, which can reveal pre-analytic variability
  • Quantification of transcript levels by digital PCR 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

If you are looking for ready-to-use purified fusion RNA materials which do not require extraction, please see our Seraseq Fusion RNA Mix v2. The Seraseq FFPE Tumor Fusion RNA Reference Material v2 is designed for use with NGS assays that detect gene fusions via sequencing of RNA transcripts.

Fusions contained in this product are not present at the DNA level. This product is intended as a quality reference material for translational and disease research testing to monitor workflow steps such as nucleic acid extraction, library preparation, and variant detection under a given set of bioinformatics parameters.

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

Seraseq FFPE Tumor Fusion RNA Reference Material v2

Doc type
Package Insert

Seraseq FFPE Tumor Fusion RNA Reference Material v2

Doc type
Product Report
Lot #
10330720

Seraseq Fusion RNA Reference Material

Doc type
Product Sheet
Lot #
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Variant List

Fusion RNA 5' Partner 3' Partner Primary Cancer Tissue
EML4-ALK EML4 exon 13 ALK exon 20 Lung
KIF5B-RET KIF5B exon 24 RET exon 11 Lung
NCOA4-RET NCOA4 exon 8 RET exon 12 Thyroid
CD74-ROS1 CD74 exon 6 ROS1 exon 34 Lung
SLC34A2-ROS1 SLC34A2 exon 4 ROS1 exon 34 Lung, Stomach
TPM3-NTRK1 TPM3 exon 7 NTRK1 exon 9 Lung, Large Intestine
FGFR3-BAIAP2L1 FGFR3 exon 17 BAIAP2L1 exon 2 Urinary Tract (rare)
PAX8-PPARG1 PAX8 exon 9 PPARG1 exon 3 Thyroid
FGFR3-TACC3 FGFR3 exon 17 TACC3 exon 11 Urinary Tract, CNS
ETV6-NTRK3 ETV6 exon 5 NTRK3 exon 15 Multiple
LMNA-NTRK1 LMNA exon 2 NTRK1 exon 10 Skin
SLC45A3-BRAF SLC45A3 exon 1 BRAF exon 8 Prostate
TMPRSS2-ERG TMPRSS2 exon 1 (5' UTR) ERG exon 2 Prostate
EGFR-SEPT14 EGFR exon 24 SEPT14 exon 10 Brain
MET exon 14 skipping MET exon 13 MET exon 15 Lung
EGFR Variant III EGFR exon 1 EGFR exon 8 Brain

Additional information including transcript IDs, breakpoint coordinates, and digital PCR data may be found in the Tecnical Product Report.

If you are looking for ready-to-use purified fusion RNA materials which do not require extraction, please see our Seraseq Fusion RNA Mix v3.

The Seraseq FFPE Tumor Fusion RNA Reference Material v2 is designed for use with NGS assays that detect gene fusions via sequencing of RNA transcripts. Fusions contained in this product are not present at the DNA level. This product is intended as a quality reference material for translational and disease research testing to monitor workflow steps such as nucleic acid extraction, library preparation, and variant detection under a given set of bioinformatics parameters.

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