To aid in the identification of patients eligible for treatment and to monitor response to therapy, DiaCarta offers QClamp® EGFR Mutation Detection Test in plasma and Formalin-Fixed Paraffin-Embedded (FFPE) samples which can lead to improved outcomes in cancer patients. The QClamp® EGFR Mutation Detection Test is an in vitro diagnostic real-time qualitative 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 with competition due to a strict 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
Detect reliably 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
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. Overexpression and oncogenic mutations that constitutively activate the TK domain of EGFR have been found in various solid
Target Therapy for EGFR
The most common activating mutations in the EGFR oncogene, exon 19
Streamlined Workflow for QClamp® EGFR 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
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|
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 is able to detect as low as 2 EGFR T790M mutant gene copies (0.125% 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 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 is able to detect as low as 1.5 copies of EGFR T790M mutant (0.1% VAF) in the background of wild-type FFPE DNA.
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. 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 firstname.lastname@example.org 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.