IVD Assay Development

Seraseq® Tumor Mutation DNA Mix v2 AF 7 HC

Material Number 0710-0095
Size 1 x 25 µL
Inventory Status In Stock
Unit EA

The Seraseq Tumor Mutation DNA Mix v2 (AF7) 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 to an allelic frequency of 7%, and is 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 includes a wide range of single nucleotide variants (SNVs), insertion-deletion mutations (indels), and structural variants (SVs).

  • Single-vial format for daily run use
  • 40 unique multiplexed variants across 28 genes (see table in Specifications tab)
    • 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 within cGMP-compliant, ISO 13485-certified facilities

The Seraseq Tumor Mutation DNA Mix v2 (AF7) HC is formulated for use with targeted next-generation sequencing (NGS) assays that detect mutations in key oncogenes and tumor suppressor genes. The Seraseq Tumor Mutation DNA Mix v2 (AF7) 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. Previous Part Number: 0710-0073.

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

Seraseq Tumor Mutation DNA Mix v2 AF7

Doc type
Certificate of Analysis
Lot #
10403956

Seraseq Tumor Mutation DNA Mix v2 AF7

Doc type
Certificate of Analysis
Lot #
10641989

Technical Spreadsheet for Seraseq Tumor DNA Mutation DNA Mixes v2 HC

Doc type
Technical Spreadsheet

Seraseq Tumor Mutation DNA Mix v2 AF 7 HC Technical Spreadsheet

Doc type
Technical Spreadsheet

Seraseq® Tumor Mutation Non-Requirement Letter

Doc type
Safety Data Sheet (Non-Requirement Letter)

Seraseq Tumor Mutation DNA Mix v2 AF7

Doc type
Safety Data Sheet (Non-Requirement Letter)

Seraseq Tumor Mutation DNA Mix v2 AF7

Doc type
Certificate of Analysis
Lot #
10219422

Seraseq Tumor Mutation DNA Mix v2 AF7

Doc type
Certificate of Analysis
Lot #
10536952

Seraseq Tumor Mutation DNA Mix v2 AF7

Doc type
Certificate of Analysis
Lot #
10523341

Seraseq Tumor Mutation DNA Mix v2 AF7

Doc type
Certificate of Analysis
Lot #
10656724

Seraseq Tumor Mutation DNA Mix v2 AF7 Package Insert

Doc type
Package Insert

Seraseq Tumor Mutation DNA Mix v2 HC

Doc type
Product Sheet
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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