EP1.09-07 Detection of EGFR Mutation by Automated and Rapid qPCR Based Biocartis IdyllaTM System in Lung Cancer Patients

Abstract

Detection of EGFR mutations in subset of Non-small cell lung carcinoma (NSCLC) has significantly changed the therapeutic management strategies in lung cancer. The Biocartis IdyllaTM EGFR detection system is used for the qualitative detection of EGFR mutations (exon 18 (G719A/C/S), exon 20 (T790M, S768I), exon 21 (L858R, L861Q) mutations, exon 19 deletions and exon 20 insertions). The system is unique as it covers the entire process from sample to result with an integrated sample preparation, followed by real time PCR amplification and detection of the targeted sequences. We present the data of series of 38 NSCLCs tested on this system with discussion on the advantages and disadvantages of the assay system. A series of thirty-eight patients of NSCLC from July 2018 to March 2019 were included in the study. An H and E stained slide was prepared from the Formalin fixed paraffin embedded (FFPE) block to document the tumor content in each case. A cut off of 10-15% tumor content was set. About 10 sections were cut with a thickness of 10 micron. Using a new razor blade, the FFPE tissue sections were scrapped onto wet filter papers. Finally, the cartridges are loaded. The IdyllaTM EGFR specific software (EGFR TTP) automatically analyzes the obtained PCR data. The test includes an integrated sample processing controls to verify adequate completion of the sample to the result process. The clinical and demographic data of these cases was analysed. The median age of the population was 66 years. Male to female ratio was 1.5:1. Of total 38 cases, 15 were positive for EGFR mutation (39.4%). 10 cases were positive for Exon 19 deletion (66.6%) and 5 cases were positive for L858R mutation (33.3%). 1. The IdyllaTM mutation assay has an edge over conventional EGFR detection system of detecting 51 mutations and indels versus 21 mutations and indel. 2. Turn around time of this assay is average of 4 to 5 hours as compared to 12-48 hours of the conventional assay. 3. The system gains appreciation for minimum requirement of high end expertise required for the testing and interpretation of the results, making it valuable to reach to the masses and provide rapid treatment base for lung cancer patients. 4. The disadvantage of this system is the non-availability of extracted DNA for additional testing.