EGFR Mutation Detection Test 

Improved sensitivity for single gene mutation detection


CE/IVD Marked Product


Research Use Product


Research Service

Early Detection/Screening


Therapy Selection

Therapy Monitoring

Introducing QClamp® EGFR Test

The QClamp® EGFR Mutation Detection Test for Formalin-Fixed Paraffin-Embedded (FFPE) samples aids in the identification of patients eligible for cancer treatment and monitor response to therapy, which can lead to improved outcomes in cancer patients. It 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 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 (for CE/IVD version) or plasma (for research use version).

With proper validation, the kit can be used for low-frequency mutation detection of important EGFR mutations such as resistance mutation T790M using plasma samples.

Ultra-sensitive: reliably detects 0.1% to 0.5% VAF mutant DNA out of wild-type DNA for targeted mutations

Low DNA input: Minimum 5ng input DNA per reaction for RUO (research use) and 10 ng DNA per reaction for CE/IVD

Fast result: Less than 4 hours of assay run time

Validated on the most common qPCR machines with minimized variability

EGFR Mutation and Lung 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, the detection of somatic mutations in the EGFR gene helps in choosing the appropriate targeted therapeutic regimens to increase the survival rate of cancer patients.

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

Powered by XNA technology, the QClamp® EGFR Mutation Detection Test has achieved a much higher analytical sensitivity than other commercial qPCR kits and other cancer gene mutation detection methods. QClamp® EGFR Mutation Detection Test can reliably detect 0.1% to 0.5% mutant DNA out of wild-type DNA for targeted mutations, providing a 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.

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

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 T790M, and L858R mutations

Sample Type


Input DNA


Validated Instruments

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

Detection Channel


Detection Chemistry


Turnaround Time

Less than 4 hours


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

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

ExonAmino Acid ChangeNucleotide changeCosmic No.
19E746_A750delc.2235_2249 del 156223
E746_T751>Ic.2235_2252 > AAT13551
E746_T751delc.2236_2253 del 1812728
E746_T751>A c.2237_2251 del 1512678
E746_S752>Ac.2237_2254 del 1812367
E746_A750delc.2236_2250 del 156225
E746_S752>Dc.2238_2255 del 186220
L747_A750>Pc.2238_2248 >GC12422
L747_T751>Qc.2238_2252 >GCA12419
L747_E749delc.2239_2247 del 96218
L747_T751delc.2239_2253 del 156254
L747_S752delc.2239_2256 del 186255
L747_A750>Pc.2239_2248 TTAAGAGAAG>C12382
L747_P753>Q c.2239_2258 >CA12387
L747_T751>Sc.2240_2251 del 126210
L747_P753>Sc.2240_2257 del 1812370
L747_T751del c.2240_2254 del 1512369
K745_E749del 2233_2247del1526038
S752_I759del 2253_2276del2413556
E746_T751>V 2237_2252>T12386
E746_T751>IP 2235_2251>AATTC13552
E746_P753>VS 2237_2257>TCT18427
L747_S752>Q 2239_2256>CAA12403
21L858R2303 G>T2573_2574TG>GTS768I12429/6241
L858>Rc.2573T>G 6224


Intended Use: QClamp® EGFR Mutation Detection Test is CE/IVD-certified. This product is available outside the USA 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 the CE/IVD version to locations outside the USA and ships the RUO version within the USA. Please call 1-800-246-8878 or email if you have questions or specific needs.

Shipping Condition: QClamp® EGFR Mutation Detection Test will be shipped with dry ice. DiaCarta provides overnight delivery through FedEx Domestic Overnight Shipping Service for domestic shipments. 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 at