Development and Clinical Application of Liquid chip Luminex Assay in theDetection of Epidermal Growth Factor Receptor and K-Ras Mutation

Abstract

Purpose: The success of molecular targeted cancer therapy relies on the accurate detection of the mutated gene. We attempted to develop a rapid, accurate, high sensitive and specific liquid chip luminex method for the detection of EGFR and K-ras mutation, both of which are an important biomarker for the personalized treatment of advanced lung cancer patients. Materials and Methods: Using the liquid chip technology, we developed a luminex system by combining PCR-LDR (Polymerase Chain Reaction-Ligase Detection Reaction) with Luminex platform for the detection of EGFR and K-ras mutation. To verify the clinical application of this liquid chip luminex system, we compared its detection results with those from the gold standard sequencing method through analysis of 100 patients. Results: The developed luminex system showed high flux, sensitivity and specificity for EGFR and K-ras gene mutation detection. Compared with sequencing for the EGFR and K-ras gene mutation detection, this luminex system showed no obvious difference in the mutation rates among different ages, histological classification and TNM stages. However, for the exon21 L585R and exon19 (including the E746-A750 deletion mutant), the luminex method showed even more effective and specificity and demonstrated obvious difference to sequencing (p Conclusion: Our liquid chip luminex system has a wide prospect of clinical application, especially for the detection of EGFR exon 21 L585R and 19 and can beused for early screening and individual therapy of patients with lung cancer.