Validation of NTRK Fusion Detection Using an Ultrarapid, Fully Automated Cartridge-based PCR Assay

NTRK gene fusions are rare but actionable oncogenic drivers, and their timely detection is critical for guiding TRK-targeted therapy. Conventional methods such as immunohistochemistry, fluorescence in situ hybridization, reverse transcription polymerase chain reaction, and next-generation sequencing can be limited by variable sensitivity, cost, and slow turnaround times. We evaluated the Idylla GeneFusion Assay—a rapid, fully automated cartridge-based platform that infers NTRK1/2/3 fusions through 3’–5’ expression imbalance—across a retrospective, fusion-enriched cohort of 193 tissue and cytology specimens from MD Anderson Cancer Center and Mayo Clinic, all of which had prior RNA-based next-generation sequencing profiling.