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Human EGFR/ALK/ROS1 Gene Mutation Combination Test Kit (Fluorescent PCR Method)
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Product Code:R-0601004Ⅰ-01/R-0601004Ⅰ-02/R-0601004Ⅰ-03/R-0601004Ⅰ-04
Product Model:Type Ⅰ (ready-to-use)
Registration Number:
Product Overview

The Human EGFR/ALK/ROS1 Gene Mutation Combination Test Kit uses NSCLC sample DNA and RNA as the test object to detect multiple EGFR gene mutations present in NSCLC by detecting EGFR gene mutations in the DNA of the sample, and ALK gene fusion and ROS1 gene fusion in the RNA of the sample by RT-PCR method, ALK gene fusion types and ROS1 gene fusion types at the same time, thus assisting the clinic in more comprehensively selecting NSCLC patients who can benefit from EGFR TKI drugs or Securitas. It is recommended to be used by NSCLC patients before entering targeted therapy to provide a scientific basis for individual drug administration for tumor patients.

Characteristics: A single test can meet the needs of clinical targeted therapy-related gene testing; easy to operate, easy to carry out, one step can be completed in 90 minutes, the required instruments are all PCR laboratory routine configuration; 1-3 slices can be satisfied.


Technological Process

Applicable samples: fresh tissue, frozen tissue, paraffin-embedded tissue, etc.


Background Information

In recent years, in the field of molecular targeted therapy for lung cancer, the research hotspots mainly focus on EGFR, ALK and ROS1 targets. Among NSCLC patients, the proportion of EGFR gene mutations in the East Asian population is about 35-40%, and about 90% of the mutations are exon 19 deletions and L858R mutations; the proportion of ALK gene fusions is about 3-11%; and the proportion of ROS1 gene fusions is about 2-4%.

The EGFR gene is an important biomarker for NSCLC patients treated with Tyrosine Kinase Inhibitors (TKIs), such as Erizal, Terokai, and Kemena, etc. NSCLC patients with ALK gene fusion and ROS1 gene fusion can benefit from treatment with the targeted drug Cyclobenzaprine.

The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, the European Society for Medical Oncology (ESMO) Lung Cancer Consensus, and the Chinese Expert Consensus on Molecular Targeted Therapy for Advanced Non-Small Cell Lung Cancer all clearly recommend that NSCLC patients should be tested for the EGFR, ALK, and ROS1 genes prior to treatment, and that the appropriate treatment strategy should be decided based on the gene status, and recommend that the units in which the conditions are available should conduct tests for the three genes at the same time. It is also recommended that units with the necessary conditions conduct the testing of the three genes at the same time.