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Mimix™ Geni™ Negative FFPE Reference Standard

The Mimix™ Geni™ Negative FFPE Reference Standard is a negative control for the Mimix Geni Onco Mix 1 DNA/RNA FFPE Reference Standard (HD852), developed in collaboration with the Medical Device Innovation Consortium (MDIC) and the National Institute of Standards and Technology (NIST) as part of the Somatic Reference Samples (SRS) Initiative led by MDIC.

Product name change
As part of the continuous evolution of our portfolio, we have changed the name of our range to Mimix™ reference standards to better reflect the patient-like performance they provide.

While our product range has a new name, everything you rely on remains the same:

  • Identical formulation and performance
  • Same part numbers and SKUs
  • Existing protocols and procedures
  • Same technical specifications
  • Quality and reliability you trust

No action is required from you. Future orders, product labels, documentation, and communications will reference the new product name.

mdic logo

The Mimix Geni Negative FFPE Reference Standard is made using the parental GM24385 Genome-in-a-Bottle Consortium cell line, one of the most tested and trusted cell lines available. This reference standard can be used as a wildtype or matched negative control for Mimix Geni Onco Mix 1 DNA/RNA FFPE reference standard (HD852) developed in collaboration with the Medical Device Innovation Consortium (MDIC) and the National Institute of Standards and Technology (NIST) as part of the Somatic Reference Samples (SRS) Initiative. It can also be used as a general FFPE workflow control, enabling comprehensive verification of end-to-end workflows, from DNA extraction to analysis.

Key Features
  • Made with GIAB GM24385 cell line
  • Tested negative for the 7 mutations engineered in HD852
  • Prepared in FFPE format to mimic patient samples and for end-to-end workflow verification
  • Ideal for creating custom dilution series with HD852 to precisely challenge and establish LOD for molecular assays
  • Can be used alongside HD852 as a negative control

Sequencing data and other publicly available cell line information can be found here Genome in a Bottle | NIST.

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

Genes covered: ERBB2, BRAF, EGFR, PDGFRA, FGFR3, TPM3-NTRK1 fusion, CCDC6-RET fusion.

Allelic frequencies: 0.00% for ddPCR-verified variants

Verified mutations:

Chromosome Gene Variant Variant Type Expected Allelic
Frequency (%)
Chr17 ERBB2 V659E MNV 0.00%
Chr7 BRAF V600E SNV 0.00%
Chr7 EGFR A763_Y764insFQEA INDEL 0.00%
Chr4 PDGFRA I843del/ I843_D846del INDEL 0.00%
Chr4 FGFR3 S249C SNV 0.00%
Chr1 TPM3-NTRK1 Fusion Fusion 0.00%
Chr10 CCDC6-RET Fusion Fusion 0.00%

 

General information

Storage: 4°C

Shipping: Ambient

Expiration: See all product shelf life information

 

Quality control

Allelic frequency: Droplet Digital™ PCR

DNA Quantification: Quantifluor®

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)

Manufacturing Quality: ISO 13485

Intended Use: For research use only. Not for use in diagnostic procedures.