Structural Multiplex Reference Standard (FFPE)

Format: FFPE

The Structural Multiplex FFPE Reference Standard is a highly-characterized, biologically-relevant quality control material, which can be used to assess the performance of NGS assays that detect structural, low-allelic somatic mutations.

With this product, you can:

•     Evaluate workflow integrity from pre-analytical DNA extraction to post-analytical bioinformatics
•     Optimize and validate the sensitivity of your workflow for structural variant detection
•     Optimize and validate new cancer panels and routinely monitor the performance of your assay

The Structural Multiplex Reference Standard covers a wide range of mutations in defined genomic context. This standard is designed to challenge your molecular and bioinformatics workflow by providing validated copy number variants/ amplifications, translocations and large insertions/deletions. Additionally, you may examine the genomic context of variants within regions of specific GC-content (high vs. low). The Structural Multiplex FFPE DNA Reference Standard includes 9 digital PCR-validated variants with allelic frequencies ranging from 3.5% to 9.7% and CNVs at 4.5x and 8.5x amplification.

Highlight features of this control material include RET and ROS1 fusion variants, MYC-N and MET focal amplifications and a BRCA2 variant.

The Structural Multiplex Reference Standard is also available in high molecular weight gDNA (HD753) and cfDNA (HD786) format.

Technical Data

Genes Covered: AKT1, BRAF, BRCA2, EGFR, FBXW7, FLT3, GNA11, KRAS, MET, MYC-N, NOTCH1, PIK3CA, RET, ROS1

Fixation Method: 4% Formalin

Section Size: 15 µm

Cell Density: 3 x 10⁸ cells per block. Approx. 3.5 x 10⁵ cells per section

Expected DNA Yield: ≥ 400 ng DNA per section using Promega Maxwell LEV Plus FFPE DNA Extraction kit


Unit Size: 1 FFPE Curl

Extractable DNA: ≥ 400 ng DNA per section using Promega Maxwell LEV Plus FFPE DNA Extraction kit

Intended Use: For routine performance monitoring (Research Use Only)

General Information
Allelic Frequency: 3.5%-9.7% and 4.5x and 8.5x amplification for the CNVs

Storage: 4˚C

Expiry: 48 months from the date of manufacture

Quality Control

Allelic Frequency: Droplet Digital™ PCR
Genotype: Droplet Digital™ PCR
Quality: Agarose gel electrophoresis
Quantification: Quantifluor™