IVD Assay Development

Seraseq® Breast CNV Mix, + 12 copies

Material Number 0710-0413
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 12 copies.

Seraseq Mix Safety Data Sheet (Non-Requirement Letter)

Doc type
Safety Data Sheet (Non-Requirement Letter)

Seraseq Breast CNV Mix

Doc type
Safety Data Sheet (Non-Requirement Letter)

Seraseq Breast CNV Mix Package Insert

Doc type
Package Insert

Seraseq Breast CNV Mix, +12 copies

Doc type
Product Report

Seraseq Copy Number Variation (CNV) Reference Materials

Doc type
Product Sheet

Seraseq Breast CNV Mix, +12 copies

Doc type
Technical Product Report
Lot #
10446810

Seraseq Breast CNV Mix, +12 copies

Doc type
Technical Product Report
Lot #
10623365

Seraseq Breast CNV Mix, +12 copies

Doc type
Certificate of Analysis/Technical Product Report
Lot #
10704888
Product Specifications
# of CNVs 3 (full gene region for ERBB2, FGFR3, and MYC)
Copy Numbers +12 copies (or 14 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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