EGFR T790M Detection Kit​ High rate of lung cancer recurrences​

Although most patients with epidermal growth factor receptor (EGFR)-mutant NSCLC respond to TKIs, patients typically develop resistance after an average of 1 year on treatment of 1st generation-TKI. EGFR genes are predictive of the response to EGFR tyrosine kinase inhibitors (TKIs). EGFR T790M is a mutation associated with acquired resistance to 1st generation EGFR-TKI therapy and has been reported in approximately 50% of Lung cancer patients with disease progression after initial response. ​

Current condition of EGFR T790M detection in Indonesia​

Assays for the detection of EGFR T790M should be designed to have an analytical sensitivity of a minimum of 5% allelic fraction. The assay for the detection will impact patients carrying the resistance mutation EGFR T790M to get benefit from the third-generation TKI Osimertinib as their targeted therapy. For testing in the setting of progression on targeted therapy, plasma biopsy is considered more feasible. However, plasma contain smaller amount of DNA, usually in short fragments (cfDNA).  Currently, available platform (Sanger sequencing and NGS) has some weakness such as insufficient sensitivity, costly or laborious. ​

Our Kit​

Based on these needs, the IVD-SCI team innovated to develop an EGFR T790M mutation detection kit that is more affordable and has good sensitivity. The kit we developed we named Diago T790M Mutation detection kit. Diago T790M Mutation Detection Kit is designed based on dual-labelled probe. Each reaction contains gene-specific primer pairs for amplification of EGFR exon 20 fragment. Further components are the FAM-labeled EGFR probe and the Cy5-labeled internal control probe, which hybridize into an internal sequence of the amplified fragments. The amplification of the wild-type sequences was suppressed, thereby enhancing the preferential amplification of the mutant sequences. This reaction competitively inhibits mutant probes to bind to the wild type, further increasing the specificity of detection. Mutant allele is detected using real time PCR (FAM dye, green channel). An internal control probe is also added to the reaction to check the amplification of each sample (Cy5 dye, red channel). The running time is only needed approximately 1.5 hours. ​