Composition for detecting multiple gene mutations of lung cancer once and application of composition

Abstract

The invention discloses a composition for detecting multiple gene mutations of lung cancer once and application of the composition. The composition comprises primers and probes for detecting EGFR, KRAS, BRAF, HER2, ALK, ROS1, RET, NTRK1, NTRK2, NTRK3 and MET gene mutations of the lung cancer and distribution modes of the primers and probes. According to the composition, the design of polymerase chain reaction (PCR) 8-tubes is employed, and every two PCR 8-tubes detect 11 gene mutations / fusion states of a sample; a corresponding fusion detection reagent and internal control reagent are held inone of the PCR 8-tubes; and a corresponding mutation detection reagent is held in the other PCR 8-tube. The composition uses a fluorescent PCR method to realize one-time detection of 119 gene fusionsand 112 gene mutation types of the lung cancer, so that detection time is greatly shortened; and operation is simple, and results are accurate; and the composition meets the urgent clinical needs of tumor patients on timely diagnosis and treatment, and helps accurate detection.

Description

technical field [0001] The invention belongs to the field of biotechnology, and more specifically relates to a primer, a probe, a detection system and a kit for one-time detection of multiple gene mutations in lung cancer. Background technique [0002] Lung cancer is one of the common malignant tumors that seriously endanger human health, and 80-85% of lung cancers are non-small cell lung cancer (NSCLC). There are many types of gene mutations in NSCLC patients, among which the mutation frequencies of EGFR, HER2, KRAS, and BRAF genes are about 10-50%, 1-4%, 5-25%, and 1-2%, respectively; ALK, ROS1, RET, The frequency of NTRK1, NTRK2, NTRK3 gene fusion is about 3-7%, 1%, 1%, 0.12%, 0.02%, 0.08%, respectively, and the frequency of MET exon 14 skipping gene mutation is about 1%. A large number of clinical studies have shown that the driver gene mutation status is an important predictor of the efficacy of targeted drug therapy. Patients with EGFR, HER2, KRAS, and BRAF gene mutat...

AI Technical Summary

Problems solved by technology

However, most of the current kits can only detect one or several gene mutations at a time, the detection throughput is low, it takes a long time, and the demand for samples is large

Although the NGS Panel currently on the market for scientific research is also possible to detect the above 11 genes at one time, the high price of NGS, cumbersome operation, complex data analysis, and large amount of samples also restrict the popularization and application of NGS methods.

At present, there is no PCR kit that can detect these 11 hotspot genes at the same time and at one time in clinical practice

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