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.
QClamp® EGFR Mutation Detection Test is CE/IVD-certified.
Advantages of QClamp® EGFR Mutation Detection Test
Reliably detects 0.1% to 0.5% VAF mutant DNA out of wild-type DNA for targeted mutations
plasma and FFPE samples
LOW INPUT DNA
Minimum 5ng input DNA per reaction. Less than 2 tubes of blood (10mL each) needed for cfDNA
Covering all relevant somatic mutations in 7 codons of
Less than 4 hours of
assay run time
Validated on the most common
qPCR machines with minimized variability
EGFR Mutation and Cancer
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
CE/IVD catalog #: DC-10-0012
Research-use-only (RUO) catalog #: DC-10-0012R
Codons 719, 861, Ex19del, Ex20insASV and S768I, T790M and L858R mutations
For In vitro diagnostic Use (CE/IVD) or for research use
Plasma and FFPE
Roche LightCycler® 480, Bio-Rad CFX384 and ABI QuantStudio 5
Less than 4 hours
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.|
|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_A750del||c.2236_2250 del 15||6225|
|E746_S752>D||c.2238_2255 del 18||6220|
|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_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|
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
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.