IVD Assay Development

Seraseq® Breast CNV Mix, + 6 copies

Material Number 0710-0412
Size 1 x 20 µL
Inventory Status In Stock
Unit EA

Copy number variations (CNV) are genomic changes that lead to higher (amplification) or lower (loss) gene copies in comparison to a reference genome. Cells that are affected by aberrant copy number changes for certain cancer-associated genes may experience disruption of normal cellular function and, ultimately, tumorigenesis. Next-generation sequencing (NGS) can be used to determine CNVs across multiple genes in a sequencing run. However, without a widely adopted standard for CNV profiling, NGS assays may evaluate dosage for different targets using different wet and dry methods. In response, SeraCare has developed the first disease-specific CNV reference materials to support clinical labs performing NGS-based tumor profiling of breast cancer patient samples.

  • Single sample with three clinically-relevant CNVs (save acquisition and sequencing costs)
  • Develop, optimize, and validate your assay’s ability to detect a range of copy numbers (amplifications)
  • CNV targets precisely quantitated with digital PCR
  • Single well-characterized GM24385 human genomic DNA as background wild-type material
  • Manufactured in GMP-compliant, ISO 13485-certified facilities

This specific CNV Mix for breast cancer includes 6 copies.

Seraseq Breast CNV Mix, +6 copies

Doc type
Product Report

Seraseq Breast CNV Mix, +6 copies

Doc type
Technical Product Report
Lot #
10446809

Seraseq Breast CNV Mix, +6 copies

Doc type
Technical Product Report
Lot #
10632778

Seraseq Mix Safety Data Sheet (Non-Requirement Letter)

Doc type
Safety Data Sheet (Non-Requirement Letter)

Seraseq Breast CNV Mix

Doc type
Package Insert

Seraseq Breast CNV Mix Package Insert

Doc type
Package Insert

Seraseq Copy Number Variation (CNV) Reference Materials

Doc type
Product Sheet
Product Specifications
# of CNVs 3 (full gene region for ERBB2, FGFR3, and MYC)
Copy Numbers +6 copies (or 8 total copies) of each gene
Concentration 10 ng/µL
Amount 200 ng (single vial)
Buffer 1 mM Tris / 0.1 mM EDTA pH 8.0

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