[REF NO.] UBP-T00324H
Ultrassay EML4-ALK Fusion Gene mutation detection kit is used for in vitro qualitative detection of 12 mutations of EML4-ALK fusion gene in human non-small cell lung cancer patients(Table 1). The test results of the kit are for clinical reference only and should not be used as the only basis for individualized treatment of patients. Clinicians should make comprehensive judgments on the test results based on factors such as the patient’s condition, drug indications, treatment response, and other laboratory test indicators.
Lung cancer is the most common malignant tumor worldwide, of which 80-85% of cases are non-small cell lung cancer (NSCLC). The gene fusion of echinoderm microtubule-associated protein-like 4(EML4) and anaplastic lymphoma kinase (ALK) is a novel target of NSCLC. EML4 and ALK are located in the P21 and P23 bands of human chromosome 2,with about 12.7 million base pairs therebetween, At least 20 fusion variants have been discovered so far, among which the 12 fusion mutants in Table 1 are the most common. The most common is mutant 1(E13;A20), followed by mutants 3a and 3b(E6;A20), accounting for 33% and 29% of NSCLC patients with the EML4-ALK fusion gene, respectively.ALK inhibitors represented by crizotinib are small-molecule targeted drugs developed for the fusion mutations of ALK gene,which inhibit the activity of ALK tyrosine kinase region and block its downstream abnormal signaling pathway, thereby inhibiting the growth of tumor cells and achieving targeted therapy of tumors . Clinical studies have shown that crizotinib has an effective rate of more than 61% in patients with EML4-ALK fusion mutations, while it has almost no effect on patients with wild-type . Therefore, detection of EML4-ALK fusion mutations is the premise and basis for guiding the use of crizotinib and other ALK inhibitors. This kit is used to guide the use of ALK inhibitors, and provide basis for the individualized medicine of NSCLC patients.