Signature® KRAS/BRAF (RUO)*
KRAS and BRAF are oncogenes involved in the epidermal growth factor receptor (EGFR) signaling
pathway that controls cell proliferation, differentiation and apoptosis.
Mutations in the KRAS and BRAF oncogenes are frequently found in human cancers, such as
colorectal cancers and non-small cell lung cancers.
The Signature® KRAS/BRAF Mutations assay is a research tool for the rapid detection of mutations in
genomic DNA extracted from human cell lines or fresh, frozen or fixed tissues.
The qualitative assay simultaneously detects:
- 6 KRAS mutations in codons 12
- 6 KRAS mutations in codon 13
- 1 BRAF mutation in codon 600
The Signature® reagents are adapted for use on the Luminex® 100 IS™ or 200™ Systems.
Assay Features:
Streamlined workflow, protocol and reagents optimized for the molecular lab
Compatible with a broad range of genomic DNA input and type*
- FFPE, biopsies, FNA, macro- or micro-dissected cells
- 6 KRAS mutations in codon 13
- Recommended input for optimal performance: 5-20 ng genomic DNA
Qualitative assay with simple data interpretation:
- A specimen is positive for a given mutation if signal ≥ validated cut off
- Recommended research use cutoff: 400-500 MFI
Analytical sensitivity* of about 1% demonstrated with genomic DNA and model FFPE
cell line dilutions
Includes internal endogenous control (EC) to assess sample DNA quality/purity
External positive and negative plate controls provided independently to assess the validity of
the amplification, hybridization and detection steps in each run
Assay Controls
The control set provides negative and positive controls for both panels:
- G12V Positive Control
- G13V Positive Control
- BRAF V600E Positive Control
- KRAS/BRAF Pooled Control (all mutations detected)
Assay Sensitivity
Analytical sensitivity* of at least 1% with KRAS mutant positive cell line DNA
diluted in KRAS WT cell line DNA
Assay Specificity
Excellent analytical specificity* with no cross detection between KRAS and BRAF
- The HCT1116 cell line is KRAS G13D positive and wild type BRAF
- The HT29 cell line is KRAS wild type and BRAF V600E positive
*Preliminary research data, the performance characteristics of this assay
are not yet established.