QClamp® EGFR 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® EGFR Mutation Detection Test for plasma and Formalin-Fixed Paraffin-Embedded (FFPE) samples aids in the identification of patients eligible for cancer treatment and in monitoring response to therapy, which can lead to improved outcomes in cancer patients. The QClamp® EGFR Mutation Detection Test is an in vitro diagnostic real-time quantitative PCR assay for the detection of somatic mutations in and near codon 719 in Exon 18, Exon 19 deletions, codons 768, 790 and insertions in Exon 20, and codons 858 and 861 in Exon 21 in the human EGFR gene, using purified DNA extracted from FFPE or plasma.

Powered by XNA technology, the QClamp® EGFR Mutation Detection Test has achieved a much higher analytical sensitivity compared to other commercial qPCR kits and other cancer gene mutation detection methods. QClamp® EGFR 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 to similar assays available in the market due to robust enrichment of mutant sequences while suppressing amplification of wild-type sequences.

Learn More about QClamp® Assays >

Product Catalog

QClamp® EGFR Mutation Detection Test – CE Version: DC-10-0012

QClamp® EGFR Mutation Detection Test – Research-Use Version: DC-10-0012R

Pack Size: 30 Samples

Customized Kits Offering

Pick one or more existing EGFR target from the standard EGFR kit: Codons 719, 861, Ex19del, Ex20insASV and S768I, T790M and L858R mutations

Service Offering

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

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Advantages of QClamp® EGFR 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 7 codons of
EGFR oncogene

FAST RESULTS

Less than 4 hours of
assay run time

GREAT VERSATILITY

Validated on the most common
qPCR machines with minimized variability

EGFR Mutation and Cancer

EGFR Introduction

The epidermal growth factor receptor (EGFR) is a membrane protein that possesses an intracellular receptor tyrosine kinase (TK) on the surface of epidermal cells. EGFR plays a central role in transmitting signals that promote cell growth, survival and proliferation by activating several downstream pathways including the Ras-Raf-MAPK pathway, the PI3-kinase-PDK1-Akt pathway, and JAK1/2-STAT pathways. EGFR overexpression and presence of oncogenic mutations that constitutively activate the TK domain of EGFR have been found in various solid tumors such as lung cancer and colorectal cancers. For instance, some of the KRAS mutations are associated with resistance to TK inhibitors, erlotinibor and gefitinib, in lung adenocarcinoma patients with EFGR mutations.

Target Therapy for EGFR

The most common activating mutations in the EGFR oncogene, exon 19 deletion and L858R, respond to certain tyrosine kinase inhibitor (TKI) cancer therapies such as GILOTRIF, GEFITINIB (Iressa) and ERLOTINIB (Tarceva), in patients with non-small cell lung cancer (NSCLC). Such mutations in the EGFR oncogene are present in the general population of patients with NSCLC at a frequency of approximately 7 to 23% in patients from the Western population of the USA and Europe, and 30 to 50% in Asian metastatic NSCLC patients. Excessive activation of EGFR has been found to be connected with cancer progression and poor prognosis. On the other hand, T790M mutation shows resistance to TKI therapy and therefore TKI therapy will not work on these patients. Thus, detection of somatic mutations in the EGFR gene helps in choosing the appropriate targeted therapeutic regimens to increase the survival rate of cancer patients.

Supporting Data for QClamp® EGFR Mutation Detection Test

QClamp® EGFR Mutation Detection Test analytical sensitivity in plasma: detects as low as 0.125% VAF mutant DNA in a 5ng input

cfDNA extracted from plasma of a colorectal cancer patient with known EGFR T790M mutation was diluted in 5ng/μl of wild-type cfDNA. VAF of the sample was verified by Next-Generation Sequencing (NGS). The EGFR T790M assay was able to detect as low as 2 EGFR T790M mutant gene copies (0.125% VAF) in the background of wild-type cfDNA.

QClamp® EGFR 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 EGFR T790M mutation was diluted in 5ng/μl of wild-type FFPE DNA. VAF of the sample was verified by NGS. The EGFR T790M assay was able to detect as low as 1.5 copies of EGFR T790M mutant (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 #: DC-10-1038
Research-use-only (RUO) catalog #: DC-10-1038R

Pack size: 30-sample

CE Catalog #: DC-10-0012
Research-use-only (RUO) catalog #: DC-10-0012R

Detected Codons

Codons 719, 861, Ex19del, Ex20insASV and S768I, T790M and L858R mutations

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 EGFR mutations detected by QClamp® EGFR Mutation Detection Test

Exon	Amino Acid Change	Nucleotide change	Cosmic No.
18	G719>A	c.2156G>C	6239
	G719>S	c.2155G>A	6252
	G719>C	c.2155G>T	6253

19	E746_A750del	c.2235_2249 del 15	6223
	E746_T751>I	c.2235_2252 > AAT	13551
	E746_T751del	c.2236_2253 del 18	12728
	E746_T751>A	c.2237_2251 del 15	12678
	E746_S752>A	c.2237_2254 del 18	12367
	E746_S752>V	c.2237_2255>T	12384
	E746_A750del	c.2236_2250 del 15	6225
	E746_S752>D	c.2238_2255 del 18	6220
	L747_A750>P	c.2238_2248 >GC	12422
	L747_T751>Q	c.2238_2252 >GCA	12419
	L747_E749del	c.2239_2247 del 9	6218
	L747_T751del	c.2239_2253 del 15	6254
	L747_S752del	c.2239_2256 del 18	6255
	L747_A750>P	c.2239_2248 TTAAGAGAAG>C	12382
	L747_P753>Q	c.2239_2258 >CA	12387
	L747_T751>S	c.2240_2251 del 12	6210
	L747_P753>S	c.2240_2257 del 18	12370
	L747_T751del	c.2240_2254 del 15	12369
	L747_T751>P	c.2239_2251>C	12383
	K745_E749del	2233_2247del15	26038
	S752_I759del	2253_2276del24	13556
	E746_A750>IP	2235_2248>AATTC	13550
	E746_T751>V	2237_2252>T	12386
	E746_T751>IP	2235_2251>AATTC	13552
	E746_S752>I	2235_2255>AAT	12385
	E746_T751>VA	2237_2253>TTGCT	12416
	E746_P753>VS	2237_2257>TCT	18427
	L747_T751del	2238_2252del15	23571
	L747_S752>Q	2239_2256>CAA	12403

20	S768I	c.2303G>T	6241/18486
	V769_D770insASV	c.2307_2308insGCCAGC...	12376/26352
	V769_D770insASV	c.2308_2309insCCAGCG...	12426
	T790>M	c.2369C>T	6240

21	L858R2303 G>T	2573_2574TG>GTS768I	12429/6241
	L858>R	c.2573T>G	6224
	L861>Q	c.2582T>A	6213

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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® EGFR Mutation Detection Test is CE/IVD-certified. Outside 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 USA and ships 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® EGFR 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.