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EGFR Gene Mutation Detection Kit

(Real Time PCR)

CE-IVD



Introduction of EGFR

Epidermal growth factorreceptor (EGFR) is a receptor tyrosine kinase, expressed in 50% of non-smallcell lung cancer (NSCLC) [1], which is closely related to theoccurrence and development of tumors. EGFR is the most frequently mutateddriver gene in NSCLC patients in East Asian population, with a mutationfrequency of 38.4%, among which East Asian female NSCLC patients have amutation frequency of 51.1% [2]. EGFR gene mutation is the mostimportant predictor of the efficacy of EGFR kinase inhibitors (TKI) and is aprerequisite for clinically determining whether patients can use EGFR-TKItherapy. Both the National Comprehensive Cancer Network (NCCN) and the ChineseSociety of Clinical Oncology (CSCO) guidelines include EGFR mutation detectionas a category 1 recommendation [3] [4]


[1]Nat Rev Cancer. 2007 Mar;7(3):169-81.

[2]Oncotarget. 2016 Nov 29;7(48):78985-78993.

[3]NCCN Clinical Diagnosis and Treatment Guidelines NSCLC 2021 V6

[4]CSCO NSCLC Diagnosis and Treatment Guidelines 2021



Common Mutations

The carcinogenic mutations of EGFR mostly occur in exons18-21, of which 19 del and L858R account for 85% to 90% of EGFR mutations [1],which are also the most common EGFR-TKI sensitive mutations. The T790M mutationsuggests resistance to the first and second generation of EGFR-TKIs while sensitiveto the third generation of EGFR-TKI. For 20 ins mutationwhichis not sensitive to traditional EGFR-TKI, suggesting the use of EGFR 20 insinhibitor.





Common mutations in the EGFR gene [1]


Detection Items


GeneMutationMedication
EGFR

19 del、L858R

Gefitinib,Erlotinib,Icotinib,Afatinib,Osimertinib,

Almonertinib,Dacomitinib

G719X、S768I、L861Q

Afatinib

T790M

Osimertinib,Almonertinib,Furmonertinib
20 insAmivantamab、Mobocertinib


Performance Parameter


Product Name Core TechnologyProduct SpecificationAdaptive ModelSample Type

Human EGFR Gene

 Mutation Detection Kit

PAP-ARMS®

10 tests / kit

Stratagene Mx3000P™, 

ABI 7500 etc.

tumor tissue,ctDNA,

pleural effusion  


Clinical Significance

1. The detection of EGFR mutation for stage II/III non-squamous cell carcinoma after operation can help guide adjuvating targeted therapies.

2. The detection of EGFR mutation for inoperable stage III and IV NSCLC patients, can help guide the treatments according to molecular classification.

3. For patients with EGFR-TKI resistance, it is recommended to perform another biopsy for EGFR gene mutation detection.


Product Highlights

Stable and Reliable: Closed tube detection to avoid cross contamination.

High Sensitivity: The detection can reach as low as 1%in 10 ng DNA.

Comprehensive Detection: Covers all available drug mutations on exons 18-21 of the EGFR gene, including sensitive mutations, T790M and 20 ins.

Simple Operation: Based on patent technology PAP-ARMS®, it needs only one step for detection.


Detection Process