Our website has a fresh new "look"
We've updated our site with modern design and easier navigation, but you'll still find the same quality Dharmacon™ reagents and Mimix™ reference standards that you love.
Mimix™ Geni™ Negative FFPE Reference Standard IVD
For In Vitro Diagnostic Use. This product is only available where licensed in accordance with law. Please contact your local representative for availability.
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:
| 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
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
We accept orders using the following methods.
Online
Our online catalog and ordering system can be used to search our full menu of available Reference Standards. Select your desired reference standards and add them to the shopping basket. Your order can be submitted instantly using credit card, telephone ordering or a purchase order number as the preferred payment method.
Offline
If you prefer to send us orders outside our online ordering system, please see the Contact Us page for telephone, fax, and email details in order to place an order. We recommend that you use our online system to identify the products you require and their respective "HD" product codes.
To order offline we will require the following information:
- Product code(s) of the item(s) you wish to order (e.g. "HD123")
- Your name, email address, title and organization
- Shipping address and billing address with contact names
- Purchase Order number if you have one
- Telephone number
- VAT Number (European Countries only)
If you're having trouble ordering or finding what you're looking for, or if you require something we don't yet offer, please contact us.
Safety data sheets
Selection guides
Reference Standards
-
At what temperature do you ship reference standards?
-
Can both DNA and RNA be extracted from the same FFPE curl?
-
How can I open the NGS data .gz files?
-
How do you recommend extracting DNA from an FFPE reference standard?
-
How is the Mimix IVD product different to the RUO version?
-
How was the batch-specific supplementary NGS data produced and analysed?
-
Is it possible to order custom versions of Mimix Reference Standards?
-
The FFPE yield is lower than expected, how can I improve the yield?
-
What batch-specific supplementary NGS data is provided?
-
Where can I access batch-specific supplementary NGS data?
-
Which extraction kits have been tested with FFPE RNA reference standards?
-
Why do I see different allele frequencies or different variants in my NGS data when comparing to the data provided with the reference standard?