# Analytical and Clinical Validation of the Oncomine Dx Express Test, an In Vitro Diagnostic-Labeled Assay, for Genomic Profiling of FFPE Tumor Samples

Source: https://onco.cc/key-papers/paper-cheng-oncomine-dx-express-validation-mol-diagn-ther-2026/  
OnCo record `paper-cheng-oncomine-dx-express-validation-mol-diagn-ther-2026` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The validation of Thermo Fisher's tissue sequencing test, which reads DNA and RNA from the same small sample.

## Summary

In 462 fixed tumour samples, agreement with orthogonal methods for RNA variants (fusions and splice variants) was 95.9 per cent positive and 100 per cent negative; RNA repeatability ranged from 88.9 per cent (ALK fusion) to 100 per cent.

## Fields

- Kind: Key paper
- Last checked: 2026-11-04
- Journal: Molecular Diagnosis and Therapy
- Year: 2026
- DOI: 10.1007/s40291-026-00884-z
- Authors: Cheng A, Nallu S, He L, et al.
- Findings: RNA variants: positive agreement 95.9%, negative agreement 100%.
- What it means: Approved tissue tests now read RNA fusions alongside DNA in one run.
- Caveats: Industry-sponsored.

## Sources

- Cheng et al., Mol Diagn Ther 2026: https://doi.org/10.1007/s40291-026-00884-z
- PubMed: https://pubmed.ncbi.nlm.nih.gov/42848264/

## Connected records

- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [RNA sequencing & expression profiling](https://onco.cc/technologies/rna-seq/)
- drugs: [Oncomine Dx Express Test](https://onco.cc/drugs/oncomine-dx-express/)
- terms: [Biomarker](https://onco.cc/terms/biomarker/)

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