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Mimix™ Geni™ Onco Mix 1 DNA/RNA FFPE Reference Standard IVD

The Mimix™ Geni™ Onco Mix 1 DNA/RNA FFPE Reference Standard IVD is an industry first pan-cancer dual DNA/RNA reference material developed in collaboration with the Medical Device Innovation Consortium (MDIC). Mutations with clinical relevance in oncology testing, as selected by a committee of industry experts, have been engineered into the GM24385 Genome-in-a-Bottle Consortium cell line, providing a highly characterized somatic cancer reference standard (SRS) you can trust to verify and monitor your oncology detection assays and workflow.

For In Vitro Diagnostic Use. This product is only available where licensed in accordance with law. Please contact your local representative for availability.

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The Mimix Geni Onco Mix 1 DNA/RNA FFPE Reference Standard IVD is a highly characterized somatic cancer reference standard developed in collaboration with the Medical Device Innovation Consortium (MDIC) as part of the Somatic Reference Samples (SRS) Initiative led by MDIC to help clinical diagnostic labs improve the accuracy of their cancer diagnostic assays. These new somatic cancer reference standards have been developed from the Genome-in-a-Bottle Consortium (GIAB) cell line, recognized by the industry as one of the most tested and trusted cell lines available. Revvity has engineered the GM24385 GIAB cell line to contain 7 cancer-relevant mutations selected by the SRS steering committee of industry experts. The mutations include 2 single nucleotide variants, 1 multi-nucleotide variant, 2 indels, and 2 gene fusions. MDIC has tested and verified this material. The reference standards will be sent to multiple labs for interlab validation and the report will be made available once complete in 2026. There is also a negative control available (HD876-IVD) which can be used as a wildtype or matched negative control for Mimix Geni Onco Mix 1 DNA/RNA FFPE reference standard IVD.

Key Features
  • Developed from an engineered Genome-in-a-Bottle Consortium cell line (GM24385)
  • Engineered with 7 cancer-relevant mutations
  • Contains DNA and RNA fusions
  • Cell line-derived for patient-like performance
  • Tested and verified by MDIC
  • Multi-lab testing using WGS underway
  • Negative control also available (HD876-IVD)

The Mimix Geni Onco Mix 1 DNA/RNA FFPE Reference Standard IVD comes with NGS data. You can access the VCF file here. Each batch was sequenced using Agilent's CREV4 (Clinical Research Exome) kit at a depth of 500x on AVITI™ platform and run through the Illumina® DRAGEN™ Somatic Pipeline for mapping, sorting, and variant calling.

 

Technical Product Information

Only DNA or RNA should be extracted at any one time. Using dual extraction kits is not recommended for this product.

Format: FFPE

Fixation method: 4% PFA (w/v)

Section size: 15µm

Cell density: 150 x 106 cells per block. Approx. 4.5 x 105 cells per section

Expected DNA yield: ≥400ng using Promega® Maxwell® RSC FFPE Plus DNA Extraction kit

Expected RNA yield: ≥100ng using Chemagic ™ CMG-1212 kit

Genes covered: ERBB2, BRAF, EGFR, PDGFRA, FGFR3, TPM3-NTRK1 fusion, CCDC6-RET fusion. Please refer the VCF file for mutations covered by NGS.

Allelic frequencies: 9.42% - 13.48%

 

Verified mutations:

Chromosome Gene Variant Variant Type Expected Allelic
Frequency (%)
Chr17 ERBB2 V659E MNV 10.82%
Chr7 BRAF V600E SNV 9.75%
Chr7 EGFR A763_Y764insFQEA INDEL 9.42%
Chr4 PDGFRA I843del/ I843_D846del INDEL 11.51%
Chr4 FGFR3 S249C SNV 10.15%
Chr1 TPM3-NTRK1 Fusion Fusion 13.48%
Chr10 CCDC6-RET Fusion Fusion 11.22%

 

General information

Storage: 4°C

Shipping: Ambient

Expiration: See all product shelf life information

Intended Use Statement:

The MimixTM GeniTM Onco Mix 1 DNA/RNA FFPE Reference Standard IVD is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl made from a multiplex of 7 engineered cell lines from the GM24385 Genome in a Bottle Consortium Cell line (GIAB), containing 5 single nucleotide polymorphisms (SNPs) and 2 gene fusions. It is intended for quantitative and/or qualitative monitoring of next-generation sequencing (NGS) or droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic mutations and gene fusions in genomic DNA (gDNA) or RNA from human samples for in vitro diagnostic use.

The gDNA or RNA obtained from Mimix Geni Onco Mix 1 DNA/RNA FFPE Reference Standard IVD can be used to monitor NGS or ddPCR workflows, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.

 

Quality control

Allelic frequency: Droplet Digital™ PCR, Reverse Transcription Droplet Digital™ PCR and Whole Exome Sequencing

DNA Quantification: Quantifluor® system

DNA Integrity: Agarose Gel Electrophoresis

RNA Quantification: Qubit® RNA HS Assay (Thermo Fisher Scientific)

RNA Integrity: DV200 ≥65% using TapeStation® High Sensitivity RNA ScreenTape Assay (Agilent)

RNA Expression: TPM3-NTRK1 ≥40 copies/ng and CCDC6-RET ≥4 copies/ng confirmed by fusion-specific RT-ddPCR using the QX200® ddPCR System (BioRad®)

Manufacturing Quality: ISO 13485

Intended Use: For in vitro diagnostic use.