Development of High Sensitive Detection Kits for EGFR and KRAS Mutations (II)

Mutaions in epidermal growth factor receptor (EGFR) and KRAS genes determine the efficacy of targeted therapy using gefitinib and erlotinib in non-small cell lung cancers (NSCLC). Detection of these mutations is thus important before applying treatment. The goal of this proposal is to develop sensitive diagnostic kits for EGFR and KRAS mutation detection, taking advantage of our newly established technology, peptide nucleic acid (PNA) probe. The kit will be suitable for analysis of DNA from tissue, pleural effusion, Bronchial alveolar lavage, and blood, and can be finished within 40 min in a single tube. The PNA probe technology is protected by a patent and secret formula. In the first year, we have made a prototype of the kit, which detects 21 EGFR mutations with a sensitivity of 0.1% mutant in the wild-type background. The stability, detection limit, and specificity of the kit are also determined. In the second year, we will produce the kit in a GMP factory and apply it for pre-clinical trials, which is necessary for applying registeration of medical devices in Food and Drug Administration. In addition, we will continue to pursue opportunity of technology transfer. In the third year, we will complete the clinical trial and put the kit into market. The product of this project will have valuable potential in both academic research and business.

Project ID:PC10102-0008
External Project ID:NSC101-2321-B182-006