QClamp® KRAS Mutation Detection Tests

Improved Sensitivity for Single Gene Mutation Detection

CE/IVD MARKED (OUTSIDE OF THE US) AND RESEARCH USE ONLY (IN THE US)

The QClamp® KRAS Mutation Detection Test for plasma and Formalin-Fixed Paraffin-Embedded (FFPE) samples aids in the identification of cancer patients eligible for treatment and in monitoring response to therapy, which can lead to improved outcomes in cancer patients. The QClamp® KRAS Mutation Detection Test is an in vitro diagnostic real-time quantitative 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.

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 reliably detect 0.1% to 0.5% mutant DNA out of wild-type DNA for targeted mutations, providing lower detection limit compared to similar assays available in the market due to robust enrichment of mutant sequences while suppressing amplification of wild-type sequences.

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Product Catalog

QClamp® KRAS Mutation Detection Test – CE Version: DC-10-3010

QClamp® KRAS Mutation Detection Test – Research-Use Version: DC-10-3010R

Pack Size: 30 Samples

Customized Kits Offering

Pick one or more existing NRAS target from the standard KRAS kit: Codons 12, 13, 59, 61, 117 and 146

Service Offering

We provide research service for QClamp® KRAS Mutation Detection Test.

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Advantages of QClamp® KRAS Mutation Detection Test

ULTRA-SENSITIVE

Reliably detects 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

The Most Frequently Mutated Oncogene in Cancer

One of the 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 are associated with poor prognosis. Mutations in KRAS may lead to abnormal growth signaling by the p21-ras protein, resulting in alterations in cell growth and division and triggering cancer development. 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

KRAS is an effector molecule involved in the transduction of signals from the epidermal growth factor receptor (EGFR) to the nucleus. EGFR is overexpressed in metastatic colorectal cancer (mCRC) and is an effective therapeutic target. Discovery of activating mutations in KRAS (exon 2, codons 12 and 13) that affect the efficiency of EGFR treatment has led to the use of KRAS 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

A recent clinical study found that about fifty percent of patients harboring wild-type KRAS and became drug-resistant during the course of treatment had gained new KRAS mutations. The 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 who would respond to anti-KRAS antibody combination therapy.

Supporting Data for QClamp® KRAS Mutation Detection Test

QClamp® KRAS Mutation Detection Test 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 was able to detect as low as 7-8 KRAS G12D mutant gene copies (0.5% VAF) in the background of wild-type cfDNA.

QClamp® KRAS Mutation Detection Test 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 was able to detect as low as 1.5 KRAS G12D mutant gene copies (0.1% VAF) in the background of wild-type FFPE DNA.

Streamlined Workflow for QClamp® Gene Mutation Detection Tests

Step 1: DNA Isolation & Quantification

Extract DNA from FFPE or plasma using a commercial DNA extraction kit and measure 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

Pack size: 10-sample

CE Catalog Number: DC-10-2010;
Research-use-only (RUO) catalog number: DC-10-2010R

Pack size: 30-sample

CE Catalog Number: DC-10-2020;
Research-use-only (RUO) catalog number: DC-10-2020R

Pack size: 60-sample

CE Catalog Number: DC-10-4020;
Research-use-only (RUO) catalog number: DC-10-4020R

Detected Codons

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

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

Exon	Amino Acid Change	Nucleotide change	Cosmic No.
2	G12>A	c.35G>C	522
	G12>R	c.34G>C	518
	G12>D	c.35G>A	521
	G12>C	c.34G>T	516
	G12>S	c.34G>A	517
	G12>V	c.35G>T	520
	G12>D	c.38G>A	532
	G12>C	c.37G>T	527
	G12>R	c.37G>C	529

3	A59>T	c.175G>A	546
	Q61>H	c.183A>C & c.183A>T	554/555
	Q61>K	c.181C>A	549
	Q61>L	c.182A>T	553
	Q61>R	c.182A>G	552

4	K117>E	c.349A>G	1360831
	K117>N	c.351A>C & c.351A>T	19940/28519
	K117>R	350A>G
	A146>A	c.438A>G	1360826
	A146>G	c.437C>G	1360829
	A146>P	436G>C	19905
	A146>T	436G>A	19404
	A146>V	437C>T>C	19900

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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. Outside the USA, this product is available for diagnostic use (CE/IVD) and research use (RUO). In the USA, this product is provided for research use only (RUO) and not for diagnostic use. DiaCarta ships CE/IVD version to locations outside the USA and ships the RUO version within 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 shipping carrier.