Automated Next-Generation Sequencing Assay Demonstrates High Concordance and Reduced Hands-On Time for EGFR and KRAS Mutation Testing for Solid Tumors
Key Clinical Takeaways
- Design/Population: Six FFPE clinical specimens were extracted manually and analyzed using a fully automated oncoReveal Dx workflow, with results compared against the standard manual oncoReveal Dx process.
- Key Outcomes: The automated workflow showed high concordance with manual testing results, significantly reduced hands-on time and touchpoints, and produced highly reproducible data.
- Clinical Relevance: The automated oncoReveal Dx workflow offers a reliable, efficient, and scalable approach for EGFR and KRAS mutation detection in NSCLC and CRC. By reducing manual complexity and turnaround time, this system may accelerate treatment initiation, improve laboratory efficiency, and broaden access to advanced NGS testing in clinical settings.
According to findings from a feasibility study, a fully automated next-generation sequencing (NGS) workflow for the oncoReveal Dx assay demonstrated strong concordance, reproducibility, and significant workflow efficiency improvements for detecting EGFR and KRAS mutations among patients with solid tumors.
These results were presented by Justin Ng, MD, Clear Labs, San Carlos, California, at the 2025 Association for Molecular Pathology (AMP) Annual Meeting and Exposition in Boston, Massachusetts.
In this study, researchers used the QIAamp DNA FFPE (formalin-fixed, paraffin-embedded) Tissue Kit to manually extract nucleic acid from 6 specimens from patients with non-small cell lung cancer (n = 3) and colorectal cancer (n = 3). Samples were loaded onto the fully automated NGS system, integrating targeted gene amplification, library preparation, sequencing, and data analysis within a single platform. Researchers also processed samples manually using oncoReveal Dx for comparison.
At analysis, the automated and manual workflows showed high concordance in variant detection across all samples. The fully automated system substantially reduced hands-on time and laboratory touchpoints, while maintaining high reproducibility and data consistency.
“The Clear Labs-developed fully automated assay described here is a promising approach for accurate and unbiased testing for EGFR and KRAS mutations from NSCLC and CRC FFPE samples, respectively. The results generated are highly comparable and reproducible,” concluded Dr. Ng and coauthors.
“Ongoing runs with more FFPE specimens are underway and will increase the power of this study,” they added.
Source:
Ng J, Khaksar D, Carter-House D, et al. A fully automated Oncoreveal Dx pan-cancer solid tumor IVD assay for the characterization of EGFR and KRAS genes in formalin-fixed, paraffin-embedded (FFPE) tissues. Presented at the 2025 AMP Annual Meeting. November 11-15, 2025; Boston, Massachusetts. ST001.
