# Analytical validation (accuracy, reproducibility, limit of detection) and gene expression analysis of FoundationOneRNA assay for fusion detection in 189 clinical tumor specimens

Source: https://onco.cc/key-papers/paper-sun-foundationone-rna-validation-plos-one-2025/  
OnCo record `paper-sun-foundationone-rna-validation-plos-one-2025` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The laboratory validation of Foundation Medicine's tumour RNA fusion test in 189 tumour samples.

## Summary

FoundationOne RNA detects fusions in 318 genes and measures expression of 1,521 genes. Against orthogonal assays, positive percent agreement was 98.28 per cent and negative percent agreement 99.89 per cent; it found a low-level BRAF fusion that orthogonal whole-transcriptome sequencing missed.

## Fields

- Kind: Key paper
- Last checked: 2026-11-04
- Journal: PLoS One
- Year: 2025
- DOI: 10.1371/journal.pone.0329697
- Authors: Sun D, Huang RSP, Green M, et al.
- Findings: Positive agreement 98.28%, negative agreement 99.89%.
- What it means: A targeted RNA test can supplement DNA profiling for fusions.
- Caveats: Analytical validation by the maker; clinical benefit not tested.

## Sources

- Sun et al., PLoS One 2025: https://doi.org/10.1371/journal.pone.0329697
- PubMed: https://pubmed.ncbi.nlm.nih.gov/40938919/

## Connected records

- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/)
- technologies: [Comprehensive genomic profiling](https://onco.cc/technologies/cgp/), [RNA sequencing & expression profiling](https://onco.cc/technologies/rna-seq/)
- drugs: [FoundationOne RNA](https://onco.cc/drugs/foundationone-rna/)
- terms: [Biomarker](https://onco.cc/terms/biomarker/)

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