Somatic Cancer
Solid Tumors
SHOP PRODUCTS
Accelerate the clinical implementation of NGS-based tumor profiling assays with reference samples comprising a broad range of clinically relevant genomic alterations. Seraseq® tumor profiling reference materials are highly multiplexed and patient-like, combining well-characterized normal or tumor cell lines with engineered biosynthetic DNA targets. For support of targeted sequencing panels, including DNA- and RNA-seq, in clinical diagnosis and biomarker-based therapeutic guidance.
Features and Benefits
- Tumor DNA reference materials include up to 113 clinically relevant variants.
- Coverage across broad variant types - SNVs, INDELs, CNVs, and gene fusions as well as genome-wide signatures
- A variety of fusion RNA reference materials with up to 22 unique fusions
- Multiple formats: purified DNA, purified RNA, or FFPE, including compromised FFPE
- Variants and fusions quantified by digital PCR and orthogonally confirmed by NGS
- Materials to meet different needs: pan-cancer profiling, solid tumor screening, targeted RNA panels, whole transcriptome RNA-seq, and cancer type- and gene-specific applications.
- The GM24385 wild-type cell line is available in different formats for use as a negative reference sample with matching genomic background.
- Manufactured in GMP-compliant and ISO 13485-certified facilities
These products are compatible with a range of NGS solid tumor assays such as:
- Archer® VariantPlex® and FusionPlex® Panels
- Illumina TruSight® Oncology 500 Sequencing Panel
- Thermo Fisher Oncomine® Comprehensive and Oncomine® Precision Assays
Tumor DNA Solutions
Seraseq Tumor Mutation DNA Mixes are available at variant allele frequencies (VAFs) ranging from 4%-10% in purified DNA format for limit of detection, sensitivity and accuracy studies of 113 variants across 92 genes, including SNVs, INDELs and translocations. The full-process Seraseq Compromised FFPE Tumor DNA Reference Material can challenge the detection of 28 clinically relevant variants among 17 genes in FFPE patient samples. The comprehensive Seraseq Solid Tumor FFPE DNA Reference Material contains 74 variants in 62 genes, the majority of which are actionable targets.
Gene List – Seraseq Tumor Mutation DNA Mixes and Seraseq Compromised FFPE Tumor DNA Reference Material
Seraseq FFPE and gDNA HRD reference materials are based on human diseased cell lines and are intended for use in validating and harmonizing NGS assays evaluating genomic instability caused by homologous recombination deficiency (HRD).
Gene List – Seraseq FFPE and gDNA HRD (High-Positive, Low-Positive, Negative) Reference Materials. 8 SNVs across 4 genes that result in Homologous Recombination Deficiency (HRD).
Seraseq gDNA BRCA1/2 LGR Mutation Mixes and Reference Material. These newly-released solutions carry 20 BRCA1 and BRCA2 gene variants blended with the wildtype GM24385 background. Ideally suited for NGS, 11 variants are large genomic rearrangements (LGRs), which are difficult to detect using current NGS assays. Available in either purified genomic DNA or FFPE formats.
CNV Solutions
Copy Number Variations (CNVs) comprise one of the most important biomarkers for cancer detection. The Seraseq® Solid Tumor CNV Reference Materials provide the most comprehensive, multiplexed CNV reference material solutions on the market, with 12 clinically-relevant, full-length genes spiked into the GM24385 cell line background. Purified gDNA and full-process FFPE formats are available.
Gene list – Seraseq Solid Tumor CNV reference materials in gDNA (+3, +6, +12 copies) and FFPE (≥3 copies) formats:
AKT1
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ERBB2
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KRAS
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MYCN
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BRAF
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FGFR3
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MET
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NTRK1
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EGFR
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KIT
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MYC
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PIK3CA
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The Seraseq Breast, Lung & Brain CNV Mix reference materials are the first disease-specific CNV reference materials to support clinical labs performing NGS-based tumor profiling of cancer patient samples. These products include varying copy number dosage of relevant genes associated with cancers of the breast, lung, and brain. Amplifications in these target genes are blended with genomic DNA from the well-characterized GM24385 cell line at 3, 6, or 12 additional copies, and precisely quantitated by digital PCR.
CNV reference materials consist of 2 sets of tumor-specific full-length genes at different amplification levels. Available as purified genomic DNA.
Gene list – Seraseq Breast, Lung & Brain CNV Mix reference materials (+3, +6, +12 copies)
Tumor RNA Solutions
Fusion RNA reference materials include the most comprehensive panel of solid tumor fusions on the market, as well as a set of hard to source NTRK fusions to support patient stratification, in purified RNA and FFPE formats. They are complemented by a unique pan-cancer fusion reference material to support whole transcriptome RNA-seq applications.
Seraseq FFPE Fusion RNA v4 Reference Material / Fusion RNA Mix v4. 18 fusions, MET4 exon skipping and alternative transcripts in FFPE and purified gDNA formats.
Seraseq Whole Transcriptome RNA Seq Mix. 22 fusions and MET4 exon skipping in purified gDNA format.
Seraseq FFPE NTRK Fusion RNA Reference Material.15 fusions across all NTRK genes in in FFPE format In FFPE format.
Fusion List - Seraseq RNA Fusion Reference Materials
