Human EML4-ALK Fusion Gene Detection Kit

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EML4-ALK Fusion Gene Detection Kit is a PCR-based in vitro diagnostic test designed to detect 12 human EML4-ALK fusion genes (V1, V2, V3a, V3b, V4, V5a, V5b, V5 “, V6, V7, V8a, V8b) in formalin fixed paraffin-embedded (FFPE) samples of clinical tumor patients for targeted drug therapy.

Product Features:

  • High Sensitivity:  accurately detect 1% of mutant DNA from 10ng of the wild-type gene
  • High Specificity:  effectively improve the testing specificity by ARMS-PCR detection technology
  • High Accuracy: closed tube reaction effectively prevent false negative and false positive results through the standard internal system and UNG enzyme system
  • Quick & Easy: easy to operate with reliable results analysis, 90 mins to complete

Product Information

Cat.No. Product Name Technology Specification Supply Format
YZYMT-021 Human EML4-ALK Fusion Gene Detection Kit PCR-Fluorescence Method 20tests/ kit  CE-IVD/RUO

Clinical Significance

ALK(anaplastic lymphoma kinase)gene and EML4(echinodermmicro tubule associated proteinlike 4)fusion gene is one of the newly discovered molecular targets of NSCLC. With biological activation, the activated EML4-ALK fusion gene affects cell proliferation,differentiation and apoptosis by activating and transmitting downstream substrate molecules.

 

The Positive rate of ALK fusion of adenocarcinoma is 5.1%, but the positive rate of ALK fusion gene in adenocarcinoma with wild-type EGFR and KRAS was as high as 30 to 42%. Some studies have shown that age is a significant independent predictor of ALK-positive NSCLC, study has found that the incidence of ALK fusion positivity was as high as 18.5% in patients younger than 51 years old, and the incidence of ALK fusions was also found to be nearly 20% in patients younger than 40 years of age.

For patients with a positive EML4-ALK fusion gene, good clinical results can be obtained with small molecule inhibitors targeting theALK genes, such as crizotinib, ceritinib and aletinib.

 

EML4-ALK Gene Corresponding Targeted Drugs

Molecular Typing Corresponding Targeted Drugs Available on Market or not
EML4-ALK Fusion Crizotinib, ceritinib, aletinib Yes
Ensartinib Yes
Brigatinib, lorlatinib Yes

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