Abstract 4145: Performance of IntelliPlexTM companion diagnostics application in cancer management

Background: Cancer is a group of various diseases with diverse causes which lead to the uncontrolled growth of abnormal cells. Understanding the genetic alteration in genes associated with cancer optimizes therapy outcomes by tailoring treatment based on each patient genetic basis. Molecular profiling is therefore a crucial tool for precision medicine to improve cancer management. Method: The IntelliPlexTM system, based on πCodeTM technology, provides a multiplexing solution for molecular profiling in just one reaction. PlexBio developed several single target gene assays utilizing DNA samples derived from formalin-fixed paraffin-embedded (FFPE) tumor tissues. The IntelliPlex EGFR Mutation kit is intended for detection of 40 mutations in the EGFR gene. The IntelliPlex BRAF V600 Mutation Kit is designed for identification of 7 nucleotide changes. The IntelliPlex KRAS Mutation Plus kit targets 25 single nucleotide changes in the KRAS gene and the IntelliPlex NRAS Mutation qualitative detects 33 single nucleotide changes in the NRAS gene. All IntelliPlex assays analyze the mutational status of each target in less than 5 hours (nucleic acid extraction not included) and allow high-throughput screening of up to 94 samples in parallel with minimal hands-on time. The performance of IntelliPlex system was evaluated on archived FFPE DNA specimens by comparing the results of the respective IntelliPlex assay with results previously obtained using the indicated commercially available molecular assays. All tests were conducted in a hospital lab located in Italy. Results: Among 76 FFPE DNA specimens tested, the overall agreement between IntelliPlex system and the comparison method was found to be 93.4%. The individual concordance for each assay kit is 90.0%, 95.8%, 93.8%, and 93.8% for EGFR, KRAS Plus, NRAS and BRAF, respectively. Conclusion: PlexBio9s IntelliPlexTM system, a multiplex detection platform, is suitable to support precision medicine in cancer management. The system offers a rapid and cost-effective way to analyze patient specimens with high sensitivity and specificity in a clinical environment. Citation Format: Lara Felicioni, Fiamma Buttitta, Antonio Marchetti, ShianPin Hu, ChenHung Chao, WenKai Liang, JuiYu Hu, Stuart Palmer, ChinShiou Huang. Performance of IntelliPlexTM companion diagnostics application in cancer management [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 4145.