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Mimix™ Structural Multiplex, FFPE Reference Standard

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.

Please note: the specification for MYC-N amplification has been updated. After analysis of all available batch data, the expected copy number has been updated from 8.5 copies to 9.5 copies. All batches after 67641 will report this updated specification on the Certificate of Analysis.

本製品は研究用です。診断にはご使用いただけません。

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.

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

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With this product you are able to:

  • 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

 

Product Information

Product Description: Structural Multiplex Reference Standard

Catalog Number: HD789

Format: FFPE

Genes Covered: GNA11, AKT1, EGFR,PIK3CA , MET, MYC-N, RET, ROS1

Fixation Method: 4% PFA (w/v)

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 RSC Plus FFPE DNA Extraction kit

Verified Mutations: 

Gene Variant (AA) CDS mutation GRCh38 co-ordinates Expected Allelic Frequency/copy number
GNA11 Q209L c.626A>T 19:3118944 4.40%
AKT1 E17K c.49G>A 14:104780214 3.50%
PIK3CA E545K c.1633G>A 3:179218303 4.50%
EGFR A767_V769dup c.2300_2308dup 7:55181317 4.40%
EGFR ΔE746 - A750 c.2235_2249del 7:55174771 4.40%
ROS1 SLC34A2/ROS1 fusion N/A  N/A 9.70%
RET CCDC6/RET fusion N/A  N/A 4.60%
MET amplification N/A  N/A 4.5 copies
MYC-N amplification N/A  N/A 9.5 copies

The gDNA format of this product (HD753) has been verified by whole exome sequencing.

Unit Size: 1 FFPE Curl

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

 

General Information

Allelic Frequency: 3.5%-9.7% and 4.5 and 8.5 copies for the CNVs

Storage: 4˚C

Shipping: Ambient

Expiration: See all product shelf life information

 

Quality Control

Genotype and Allelic Frequency: Droplet Digital™ PCR

DNA Integrity: Agarose gel electrophoresis

Quantification: Quantifluor™

Manufacturing Quality: ISO 13485:2016

Intended use: For assay developers and molecular diagnostic labs for routine performance monitoring of molecular biology assays. Research use only. Not for diagnostic procedures.