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Human EGFR Gene T790M Mutation Detection Kit

Human EGFR Gene T790M Mutation Detection Kit

Digital PCR assay

CE-IVD Certificate no.:No.MDD-SZ-XWA1-180523

Only for scientific research use in China


According to the detection of EGFR status for patients with NSCLC, exon 19 deletions mutations are found in 45% of the patients, and a mutation of exon 21 L858R is about 40%- 45%, while the mutations of exon 20 insertions occupies about 5%. The first and second generations of EGFR-TKI drugs are effective for patients harboured EGFR mutation menttioned above. Studies have shown that most EGFR-mutant NSCLC patients have a good response to EGFR-TKI initially. However, approximately 50-65% of the patients will have drug resistance caused by T790M mutation of EGFR after they have been treated with EGFR-TKI drugs for about 10 months.




Mechanismsof acquired resistance to first- and second-generation EGFR tyrosine kinaseinhibitors

WestoverD et al. Ann Oncol.2018 Jan 1;29(suppl_1):i10-i19. doi: 10.1093



Performance Parameter


Product NameDetecting ItemTechnologyProduct SpecificationSample TypeMatched Instrument

Human EGFR Gene 

T790M Mutation 

Detection Kit

EGFR-T790MDigital PCR10 tests/kit

tumor tissue,

 ctDNA,, 

pleural effusion

Bio-Rad QX200,

Life QuantStudio 3D


Detection significance


Through the detection of EGFR-T790M ,  the patients with drug resistance can be predicted earlier than the progress of the disease can be identified by conventional radiology.


The detection results of EGFR-T790M can be used to predict the efficacy of the first and second generations of EGFR-TKI drugs and guide the selection for suitable  target treatments.


 Applicable People


The patients with drug resistance to the first /second generation of EGFR-TKI drugs.

 The advanced patients who will be treated with Ochitinib, a detection of EGFR-T790M status is recommended.



Highlights



Easy operation: Only 5 working days from sample processing to reporting.

Accuracy and ReliabilityThis kit can quantitatively detect the mutation abundance of T790M. The results can help monitor the development of the disease and adjust the therapeutic treatments in time .

High Sensitivity:This kit can detect as low as 0.1% mutation.More opportunities of treatments  for patients with drug resistance who can not be acquired secondary biopsy. 

No internal reference needed:Avoid fake negative.



Detection Process








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