SPACEGEN - EGFR Gene T790M/L858R Mutation Detection Kit （Digital PCR）

Epidermal growth factor receptor (EGFR) is a receptor tyrosine kinase, which is expressed in 50% of non-small cell lung cancer (NSCLC), and is closely related to the occurrence and development of tumor. Carcinogenic mutations of EGFR mostly occur in exons 18~21, among which L858R accounts for 40% ~ 45% of all EGFR mutations, and it is the most common EGFR-TKI sensitive mutation. In addition, T790M mutation indicates that the first and second generation EGFR-TKI are resistant, so the third generation EGFR-TKI should be used. The guidelines of National Comprehensive Cancer Network (NCCN) and China Clinical Oncology Association (CSCO) have written EGFR mutation detection into Class 1 recommendation , and it is also clearly stated in the guidelines that "EGFR mutation detection can be carried out through peripheral blood free/tumor DNA(cf/ctDNA) when tumor samples are unavailable or too few for gene detection.

ctDNA INTRODUCTION
CtDNA is released into blood vessels by tumor cells or circulating tumor cells through apoptosis, necrosis, phagocytosis or active secretion, which can reflect the real-time tumor load in vivo, dynamically monitor the curative effect of drugs, and predict the disease changes in advance. CtDNA has become a dynamic biomarker based on plasma, which plays an important role in the fields of early diagnosis of tumors, molecular typing, targeted drug selection, and monitoring of minimal residual lesions. Because the content of ctDNA is usually less than 1% of the total cfDNA of individuals, screening ctDNA from a large number of cfDNA requires high detection sensitivity. The liquid biopsy technology based on digital PCR makes it possible to detect low-concentration ctDNA.

Core Technology:PAP-ARMS®

Applicable Disease:Non-small cell lung cancer

Instruments Validated:Bio-Rad：QX200

Sample Type:Tumor tissue,Peripheral blood,Pleural effusion &Ascites

1.Select patients for the treatment of EGFR T790M/ L858R mutation-positive NSCLC with third-generation EGFR-TKIs following progression on or after EGFR TKI therapy based on the presence of an EGFR T790M/ L858R mutation in tumor or plasma specimens.

2.Select patients for treatment with EGFR-TKIs based on the presence of EGFR-L858R.

1.High Sensitivity: DNA samples with mutation frequency as low as 0.1% can be detected.

2.Quantitative Accuracy: Quantitative detection of gene mutation abundance, timely detection of disease progress, adjustment of treatment programs.

3.No need for internal standard: Reduce false negative results.