KRAS Mutation Detection Test | DiaCarta, Inc.

To aid in the identification of patients eligible for treatment and to monitor response to therapy, DiaCarta offers QClamp® KRAS Mutation Detection Test in plasma and Formalin-Fixed Paraffin-Embedded (FFPE) samples which can lead to improved outcomes in cancer patients. The QClamp® KRAS Mutation Detection Test is an in vitro diagnostic real-time qualitative PCR assay for the detection of somatic mutations in and near codons 12 and 13 in Exon 2, codons 59 and 61 in Exon 3, and codons 117 and 146 in Exon 4 in the human KRAS gene, using purified DNA extracted from FFPE or plasma.

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Powered by XNA technology, the QClamp® KRAS Mutation Detection Test has achieved a much higher analytical sensitivity compared to other commercial qPCR kits and other cancer gene mutation detection methods. QClamp® KRAS Mutation Detection Test is able to detect reliably 0.1% to 0.5% mutant DNA out of wild-type DNA for targeted mutations, providing lower detection limit compared with competition due to a strict enrichment of mutant sequences while suppressing amplification of wild-type sequences.

QClamp® KRAS Mutation Detection Test is CE/IVD-certified.

Advantages of QClamp® KRAS Mutation Detection Test

ULTRA-SENSITIVE

Detect reliably 0.1% to 0.5% VAF mutant DNA out of wild-type DNA for targeted mutations

SAMPLE READY

Suitable for
plasma and FFPE samples  

LOW INPUT DNA

Minimum 5ng input DNA per reaction. Less than 2 tubes of blood (10mL each) needed for cfDNA

COMPREHENSIVE COVERAGE

Covering all relevant somatic mutations in 6 codons of
KRAS oncogene

FAST RESULTS

Less than 4 hours of
assay run time  

GREAT VERSATILITY

Validated on the most common
qPCR machines with minimized variability

KRAS Mutation and Cancer

KRAS: the Most Frequently Mutated Oncogene in Cancer

The most common cancer gene mutations, Kirsten rat sarcoma viral oncogene (KRAS) mutations, are found in several cancers including pancreatic (80 to 90%), colorectal (25 to 60%), lung (25 to 60%) cancers, and associated with poor prognosis. KRAS mutations may lead to abnormal growth signaling by the p21-ras protein. The alterations in cell growth and division may trigger cancer development as signaling is excessive. Currently, there is no effective treatment for cancers carrying KRAS mutations and KRAS protein is not directly druggable.
 
 
 

KRAS as an Important Biomarker for Targeted Therapy

The epidermal growth factor receptor (EGFR), which is overexpressed in metastatic colorectal cancer (mCRC) has become an effective therapeutic target. Discovery of activating mutations in KRAS (exon 2, codons 12 and 13) that affect the efficiency of treatment has led to the use of these biomarkers to predict patient response to drug therapy. For example, a KRAS mutation is considered to be a strong prognostic marker of response to tyrosine kinase inhibitors such as gefitinib (Iressa) or erlotinib (Tarceva). KRAS mutations have also been detected in many colorectal cancer patients and are associated with responses to cetuximab (Erbitux) or panitumumab (Vectibix), which are used in colon cancer therapy.

Recent Clinical Study

For patients who receive treatment while having wild-type KRAS and later become drug-resistant, about fifty percent of patients gained new KRAS mutations. The recent PEAK Phase 2 clinical study of Panitumumab and Bevacizumab plus mFOLFOX6 for first-line treatment of mCRC illustrated the need to extend testing of KRAS mutations at codons 61, 117 and 146 for selection of patients that would respond to anti-KRAS antibody combination therapy.
 
 
 
 
 

Streamlined Workflow for QClamp® KRAS Mutation Detection Tests

Step 1: DNA Isolation & Quantification

Extract DNA from FFPE or plasma using a commercial DNA extraction kit followed by measuring the concentration using fluorometric analysis

Step 2: set up qpcr

Mix the assay reagents, load into PCR plate, add controls and extracted DNA ~ 30-60 minutes

Step 3: Amplification parameters

Enter amplification parameters on
qPCR instrument, load PCR plate
and start the run ~ 2.5 hours

Step 4: Data analysis

Determine the presence or absence
of mutations according to the Cq
value cutoffs ~ 15 minutes

Resources

Catalog Number 

CE/IVD catalog Number: DC-10-3010;
Research-use-only (RUO) catalog number: DC-10-3010R

Pack Size

30 samples

Detected Codons

Codons 12, 13, 59, 61, 117 and 146

Intended Use

In vitro diagnostic Use (CE/IVD) or for research use

Sample Type

Plasma and FFPE

Input DNA

5-10ng/Reaction

Validated Instruments

Roche LightCycler® 480, Bio-Rad CFX384 and ABI QuantStudio 5

Detection Channel

FAM; HEX

Detection Chemistry

TaqMan

Turnaround Time

Less than 4 hours

Stability

Stable for 12 months at -25 ℃ to -15 ℃

Most frequent KRAS mutations detected by QClamp® KRAS Mutation Detection Test

ExonAmino Acid Change Nucleotide change Cosmic No.
2G12>Ac.35G>C522
G12>Rc.34G>C518
G12>Dc.35G>A521
G12>Cc.34G>T516
G12>Sc.34G>A517
G12>Vc.35G>T520
G12>Dc.38G>A532
G12>Cc.37G>T527
G12>Rc.37G>C529
 
3A59>Tc.175G>A546
Q61>Hc.183A>C & c.183A>T554/555
Q61>Kc.181C>A549
Q61>Lc.182A>T553
Q61>Rc.182A>G552
 
4K117>Ec.349A>G1360831
K117>Nc.351A>C & c.351A>T19940/28519
K117>R350A>G
A146>Ac.438A>G1360826
A146>Gc.437C>G1360829
A146>P436G>C19905
A146>T436G>A19404
A146>V437C>T>C19900

Analytical sensitivity in plasma: Detects as low as 0.5% VAF mutant DNA in a 5ng input

cfDNA extracted from plasma of a colorectal cancer patient with known KRAS G12D mutation was diluted in 5ng/μl of wild-type cfDNA. VAF of the sample was verified by Next-Generation Sequencing (NGS). The KRAS c12 assay is able to detect as low as 7-8 KRAS G12D mutant gene copies (0.5% VAF) in the background of wild-type cfDNA.

Analytical sensitivity in FFPE: Detects as low as 0.1% VAF mutant DNA in a 5ng input

DNA extracted from FFPE of a colorectal cancer patient with known KRAS G12D mutation was diluted in 5ng/μl of wild-type FFPE DNA. VAF of the sample was verified by NGS. The KRAS c12 assay is able to detect as low as 1.5 KRAS G12D mutant gene copies (0.1% VAF) in the background of wild-type FFPE DNA.

 

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Ordering Information

For products that are in stock, DiaCarta will arrange shipment in 1-3 days. For products that are on backorder, DiaCarta will arrange shipment in 3-5 weeks.
Intended Use: QClamp® KRAS Mutation Detection Test is CE/IVD-certified. For the outside USA, this product is available for diagnostic use (CE/IVD) and research use (RUO). For the USA, this product is provided for research use only (RUO) and not for diagnostic use. DiaCarta ships CE/IVD version to the outside USA and ships RUO version to the USA. Please call 1-800-246-8878 or email order@diacarta.com if you have questions or specific needs.
Shipping Condition: QClamp® KRAS Mutation Detection Test will be shipped with dry ice. For domestic shipment, DiaCarta provides overnight delivery through FedEx Domestic Overnight Shipping Service. For international shipment, DiaCarta provides 3-7 days in transit through FedEx International Priority Shipping Service. Please contact DiaCarta if you prefer to use your own shipping carrier.

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Email us: information@diacarta.com

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