ADPS_EGFR_Mutation_Test_Kit

ADPS
EGFR Mutation Test Kit v1

CE-IVD Marked RUO Marked

Supporting precision medicine for more patients

Key Feature

EGFR is a membrane protein that transmits signals that promote cell growth and proliferation, and is strongly associated with certain types of cancer. EGFR mutations are identified in approximately 20% NSCLC patients in Western populations and 40 to 55% of NSCLC patients in East Asian populations. Most EGFR mutations occur in exons 18–21.

EGFR mutations are targeted by specific tyrosine kinase inhibitors (TKIs), and the EGFR T790M mutation is used as a resistance biomarker. Therefore, the analysis of EGFR mutations in NSCLC patients can help personalize treatment for patients.

The ADPS™ EGFR Mutation Test Kit v1 detects 44 mutations in exons 18 to 21 of the EGFR gene with a detection sensitivity ranging from 0.01% to 0.1%. It is designed to allow testing of both tissue and plasma samples with a single kit.

In Europe, medical professionals can prescribe EGFR TKI based on the analysis results. In other regions, it is for research use only (RUO) and cannot be used in diagnostic procedures.

ADPS_EGFR_Mutation_Test_Kit
Catalog No.  (IVD) D8000APA (RUO) R8000APA
Detection target 44 mutations in EGFR exon 18, 19, 20 and 21
Assay type qPCR
Sample type DNA extracted from FFPE, frozen, and fresh cancer tissue or liquid biopsy
Master Mixture
(MMX)
4MMXs
Internal Control EGFR exon 4
Detection Sensitivity 0.01~0.1%(FFPET), 10~60copies/mL(plasma)
Detection Specificity ≥ 99%
Precision (% CV) ≤ 5% (CV, coefficient of variation)
Storage -20±5℃
Stability 18 months
Freeze/Thaw stability 5 times
Compatible Instruments IVD - AB7500Fast / 
RUO – AB7500Fast, CFX96, Roter-Gene Q, 
LightCycler 480, QuantStudio 5 

ADPS™ Oncogene Mutation Test

PRODUCTS