EGFR Mutation Test
Supporting precision medicine for more patients: ADPS™ EGFR Mutation Test Kit v1
EGFR mutations occur in non-small cell lung cancer (NSCLC) at a frequency of about 50%.
44 somatic mutations in the EGFR gene can be detected accurately and quickly
with a detection sensitivity of 0.01~0.05%.
Clinicians can prescribe EGFR TKI according to diagnosis.
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Key Features
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Detection sensitivity 0.01~0.05%
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Specificity ≥ 99%
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Turnaround time 1.5hrs
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Applicable to
liquid biopsy or
tissue biopsy
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real-time PCR data sample
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VIC L858R mutant
(copies)gDNA
(copies)Red 30,000 0 Orange 3,000 27,000 Green 300 29,700 Blue 30 29,970 Violet 3 29,997 Black 0 30,000 -
Intended Use
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The ADPS™ EGFR Mutation Test kit v1 is a real–time PCR assay for qualitative detection of 44 somatic mutations in exons 18-21 of the EGFR gene.
DNA extracted from formalin-fixed paraffin-embedded samples of tissue biopsy or circulating cell-free DNA extracted from liquid biopsy can be used.
The kit is for in vitro diagnostic use by trained professionals in a laboratory setting. -
Targeted mutations
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Exon Mutation EGFR Nucleic Acid Sequence (COSMIC ID) Exon 18 G719X 2155G>A (6252), 2155G>T (6253), 2156G>C (6239) Exon 19 Ex19Del 2240_2251del12 (6210) , 2239_2247del9 (6218) , 2238_2255del18 (6220) , 2235_2249del15 (6223) , 2236_2250del15 (6225) , 2239_2253del15 (6254) , 2239_2256del18 (6255) , 2237_2254del18 (12367) , 2240_2254del15 (12369) , 2240_2257del18 (12370) , 2239_2248TTAAGAGAAG>C (12382) , 2239_2251>C (12383) , 2237_2255>T (12384) , 2235_2255>AAT (12385) , 2237_2252>T (12386) , 2239_2258>CA (12387) , 2239_2256>CAA (12403) , 2237_2253>TTGCT (12416) , 2238_2252>GCA (12419) , 2238_2248>GC (12422) , 2237_2251del15 (12678) , 2236_2253del18 (12728) , 2235_2248>AATTC (13550) , 2235_2252>AAT (13551) , 2235_2251>AATTC (13552) , 2253_2276del24 (13556) , 2237_2257>TCT (18427) , 2238_2252del15 (23571) , 2233_2247del15 (26038) , 2232_2249del18 (221565) , 2234_2248del15 (1190791) Exon 20 S768I 2303G>T (6241) T790M 2369C>T (6240) Ex20Ins 2307_2308ins9GCCAGCGTG (12376) , 2319_2320insCAC (12377) , 2310_2311insGGT (12378) , 2311_2312ins9GCGTGGACA (13428) , 2309_2310AC>CCAGCGTGGAT (13558) Exon 21 L858R 2573T>G (6224) , 2573_2574TG>GT (12429) L861Q 2582T>A (6213) -
Product information
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- Catalog No.D8000APA
- Detection
technologyAllele-Discriminating Priming System (ADPS™) - Compatible qPCR machinesAB7500 FAST
- CE No.NL-CA002-2020-49586
Tube Contents Quantity EGFR Master Mixture 1 400 μL/tube EGFR Master Mixture 2 400 μL/tube EGFR Master Mixture 3 400 μL/tube EGFR Master Mixture 4 400 μL/tube ADPS™ Smart DNA Polymerase 80 μL/tube EGFR Positive Control 100 μL/tube Nuclease-Free Water 1.0 mL/tube -
Related diseases
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Non-small cell lung cancer (NSCLC)
Any type of epithelial lung cancer other than small cell lung cancer (SCLC).
NSCLC accounts for about 85% of all lung cancers.Frequency of mutations in NSCLC
Mutation frequency and distribution in Asian and Caucasian populations
EGFR Biomarker-Directed Therapies (NCCN guideline)
EGFR TKIs EGFR mutations Gefitinib, Erlotinib Exon 19 deletions and L858R Osimertinib T790M -
Protocol
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Workflow
Required DNA amount
-The maximum detection sensitivity of ADPSTM EGFR Mutation Test Kit v1 is 0.01%(3/30,000), thus up to 99 ng of DNA can be used for reaction based on the table below -EGFR testing (for 44 mutations) consists of 4 reactions, thus up to 396 ng (99 ng x 4) can be used.
Tube DNA amount / reaction 1 ng 10 ng 99 ng Input DNA (copies) 300 3,000 30,000 Limit of detection (copies) 3 3 3 Detection sensitivity (maximum) 1% 0.10% 0.01% EGFR test plate Example (96 wells)
MMX1
PCSample
1Sample
3Sample
5Sample
7Sample
9Sample
11Sample
13Sample
15Sample
17Sample
19Sample
21MMX2
PCMMX3
PCMMX4
PCMMX1
NTCSample
2Sample
4Sample
6Sample
8Sample
10Sample
12Sample
14Sample
16Sample
18Sample
20Sample
22MMX2
NTCMMX3
NTCMMX4
NTC1.ADPS™ EGFR Mutation Test Kit v1 (for 44 mutations) consists of 4 reactions (MMX1~4). 2.22 samples can be tested per 1 plate running.
-MMX : Multiplex Mix -PC : Positive Control -NTC : No-Template Control (negative control)