The Mimix Geni Negative FFPE Reference Standard IVD 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 IVD (HD852-IVD) developed in collaboration with the Medical Device Innovation Consortium (MDIC) 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-IVD
• Prepared in FFPE format to mimic patient samples and for end-to-end workflow verification
• Ideal for creating custom dilution series with HD852-IVD to precisely challenge and establish LOD for molecular assays
• Can be used alongside HD852-IVD as a negative control
• Sequencing data and other publicly available cell line information can be found here: Genome in a Bottle.

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: 0.00% for ddPCR-verified variants

Verified mutations:

General information

Storage: 4°C

Shipping: Ambient

Expiration: See all product shelf life information

Intended Use Statement:
The MimixTM GeniTM Negative FFPE Reference Standard IVD is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl derived from the GM24385 Genome-in-a-Bottle Consortium (GIAB) cell line, with no additional genomic interventions. It is intended for qualitative and/or quantitative monitoring of next generation sequencing (NGS) and droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic oncogenic 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 Negative 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

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)

Manufacturing Quality: ISO 13485

Intended Use: For in vitro diagostic use