21P Analytical performance of FusionPlex Dx

FusionPlex Dx (FP Dx) is a 2-part multimodal next-generation sequencing (NGS)-based in vitro diagnostic kitted device that detects structural alterations and oncogenic isoforms RNA derived from formalin-fixed, paraffin-embedded (FFPE) samples solid tumors using proprietary Anchored Multiplex PCR (AMP™) chemistry. FP approved as companion for five indications: METex14 skipping events, ALK, RET, ROS1 gene fusions to guide therapy non-small cell lung cancer NTRK1/2/3 all tumors. The assay also provides comprehensive genomic profiling patients with This study summarizes the analytical performance of Dx. instructions use were followed studies. Total nucleic acid was extracted 1132 unique clinical FFPE specimens positive or negative ≥40 tumor types 4 commercial reference generating total 3279 libraries. Libraries sequenced on Illumina MiSeqDx NextSeq 550Dx platforms. Pre-defined in-process control metrics used monitoring library preparation sequencing, only libraries meeting these included analysis (97.65%). Data processed via software, R Analysis Suite Statistical Software, Invitae Solid Tumor IVD Analysis. limit detection measured be 22 reads alteration (ALK, fusions), 26 – 35 31 NTRK fusions. accuracy evaluated by comparison TST-170 NGS, Oncomine Focus TSO Comp assays. Concordance agreement results >95%, demonstrating Overall reproducibility NTRK, METex14, ≥99.15%, repeatability ≥92.50%, consistent precision Collectively, data support Dx’s ability detect alterations. capabilities Assay chemistry software allow exhaustive characterization sensitivity targeted alterations, even without prior knowledge fusion partners breakpoints.