IVD Assay Development

Seraseq® Tri-Level Tumor Mutation DNA Mix v2 HC

Material Number 0710-0097
Size 1 x 25 µL
Inventory Status In Stock
Unit EA

The Seraseq Tri-Level Tumor Mutation DNA Mix v2 (HC) is a multiplexed mixture of actionable biosynthetic DNA targets precisely blended with a single, well-characterized genomic background. This product is produced under rigorous design control and manufacturing practices, offered in a high concentration (HC) format at 25 ng/µL. Designed to assess the overall performance of your somatic mutation assay by next-generation sequencing (NGS), this unique product offers a range of allele frequencies in a single sample format, including single nucleotide variants (SNVs), insertion-deletion mutations (indels), and structural variants (SVs).

  • Single-sample format for daily run use
  • 40 unique multiplexed variants across 28 genes (see table in Specifications tab) at allele frequencies distributed at 4%, 7% or 10%
    • 20 SNVs
    • 5 SNVs that are part of homopolymers
    • 13 indels
    • 2 SVs
  • Mutation targets quantitated with digital PCR
  • Well-characterized GM24385 human genomic DNA as background ‘wild-type’ material
  • Manufactured under cGMP within ISO 9001 and ISO 13485 certified facilities

The Seraseq Tri-Level Tumor Mutation DNA Mix v2 (HC) is formulated for use with targeted next-generation sequencing (NGS) assays that detect mutations in key oncogenes and tumor suppressor genes. The Seraseq Tri-Level Mutation DNA Mix v2 (HC) is intended as a quality reference material for translational and disease research testing to monitor library preparation, sequencing, and variant allele detection under a given set of bioinformatics pipeline parameters.

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

Seraseq Tri-Level Tumor Mutation DNA Mix v2

Doc type
Certificate of Analysis
Lot #
10321209

Seraseq Tri-Level Tumor Mutation DNA Mix v2

Doc type
Certificate of Analysis
Lot #
10329443

Seraseq Tri-Level Tumor Mutation DNA Mix v2

Doc type
Certificate of Analysis
Lot #
10621387

Seraseq Tri-Level Tumor Mutation DNA Mix v2

Doc type
Certificate of Analysis
Lot #
10469093

Seraseq Tri-Level Mutation DNA Mix v2

Doc type
Certificate of Analysis
Lot #
10420449

Seraseq® Tumor Mutation Non-Requirement Letter

Doc type
Safety Data Sheet (Non-Requirement Letter)

Seraseq Tri-Level Tumor Mutation DNA Mix v2

Doc type
Safety Data Sheet (Non-Requirement Letter)

Seraseq Tri-Level Tumor Mutation DNA Mix v2 HC

Doc type
Product Sheet

Seraseq Tri-Level Tumor Mutation DNA Mix v2

Doc type
Certificate of Analysis
Lot #
10551335

Seraseq Tri-Level Tumor Mutation DNA Mix v2

Doc type
Certificate of Analysis
Lot #
10507945

Seraseq Tri-Level Tumor Mutation DNA Mix v2

Doc type
Certificate of Analysis
Lot #
10329444

Seraseq Tri-Level Tumor Mutation DNA Mix v2

Doc type
Certificate of Analysis
Lot #
10481539

Seraseq Tri-Level Tumor Mutation DNA Mix v2

Doc type
Certificate of Analysis
Lot #
10663058

Seraseq Tri-Level Tumor Mutation DNA Mix v2

Doc type
Certificate of Analysis
Lot #
10592800

Seraseq Tri-Level Tumor Mutation DNA Mix v2 Package Insert

Doc type
Package Insert

Seraseq Tri-Level Tumor Mutation DNA Mix v2 Technical Spreadsheet

Doc type
Technical Spreadsheet
Gene List
AKTI FGFR3 JAK2 PDGFRA
APC FLT3 KIT PIK3CA
ATM FOXL2 KRAS PTEN
BRAF GNA11 MPL RET
CTNNB1 GNAQ NCOA4-RET SMAD4
EGFR GNAS NPM1 TP53
ERBB2 IDH1 NRAS/CSDE1 TPR-ALK

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