{"entity":{"id":"foundationone-rna","kind":"drug","name":"FoundationOne RNA","aka":["F1 RNA","FoundationOneRNA"],"tldr":"An add-on to Foundation Medicine's tumour DNA test that reads RNA to find gene fusions, some of which DNA testing misses.","summary":"Foundation Medicine describes \"a laboratory-developed test (LDT) for all solid tumors\" that \"uses hybrid capture-based next generation sequencing (NGS) to detect cancer-related gene fusions and rearrangements from RNA across 318 genes\", \"only available as an add-on to FoundationOne CDx\", and states that it \"has not been cleared or approved by the U.S. Food and Drug Administration\". Its analytical validation in 189 tumour specimens reported 98.28 per cent positive and 99.89 per cent negative percent agreement with orthogonal assays and measures expression of 1,521 genes (Sun 2025).","status":"established","asOf":"2026-11-04","links":[{"label":"Foundation Medicine: FoundationOne RNA","url":"https://www.foundationmedicine.com/solution/foundationone-rna"}],"tags":["test","rna"],"related":["tempus-xr","archer-fusionplex"],"cancers":[],"sections":[],"technologies":["rna-seq","cgp"],"targets":[],"drugs":[],"companies":["foundation-medicine"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-sun-foundationone-rna-validation-plos-one-2025"],"journals":[],"dependsOn":[],"notes":[],"brand":"FoundationOne RNA","modality":"Targeted tumour RNA sequencing test (fusions in 318 genes)","mechanism":"Hybrid-capture sequencing of RNA co-extracted from the FoundationOne CDx sample detects fusions and rearrangements in 318 genes.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/foundationone-rna/","neighbours":{"drug":[{"id":"archer-fusionplex","kind":"drug","name":"Archer FusionPlex panels","route":"/drugs/archer-fusionplex/"},{"id":"tempus-xr","kind":"drug","name":"Tempus xR","route":"/drugs/tempus-xr/"}],"technology":[{"id":"cgp","kind":"technology","name":"Comprehensive genomic profiling","route":"/technologies/cgp/"},{"id":"rna-seq","kind":"technology","name":"RNA sequencing & expression profiling","route":"/technologies/rna-seq/"}],"company":[{"id":"foundation-medicine","kind":"company","name":"Foundation Medicine (Roche)","route":"/companies/foundation-medicine/"}],"paper":[{"id":"paper-sun-foundationone-rna-validation-plos-one-2025","kind":"paper","name":"Analytical validation (accuracy, reproducibility, limit of detection) and gene expression analysis of FoundationOneRNA assay for fusion detection in 189 clinical tumor specimens","route":"/key-papers/paper-sun-foundationone-rna-validation-plos-one-2025/"}]}}