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Real-World Performance of the EasyPGX® Ready Epidermal Growth Factor Receptor Assay for Genomic Testing of Non-Small
Michael Bento Schmid1, Izadora Demmer1, Sandra Floriani1
1Institute of Pathology, Cantonal Hospital St. Gallen, 9007 St. Gallen, Switzerland.
Abstract:
Background/Objectives: Activating epidermal growth factor receptor (EGFR) variants is the most common targetable alteration in non-small cell lung cancer (NSCLC). Clinical decision-making requires fast and reliable detection of EGFR variants in early and advanced NSCLC, but limited available tissue necessitates tissue-sparing approaches and optimized sample management. The objective of this study was to assess the performance of the commercial EasyPGX® ready EGFR assay using real-world clinical NSCLC samples. Methods: A consecutive cohort of 804 non-squamous NSCLC samples was prospectively analyzed with the real-time quantitative polymerase chain reaction (RT-qPCR)-based EasyPGX® ready EGFR assay (Diatech Pharmacogenetics, Jesi, Ancona, Italy) and compared to next-generation sequencing (NGS) assays. Results: NGS revealed conclusive results in 99.7% samples, of which 11.1% had at least one EGFR variant. The most common variants were exon 19 deletions and p.L858R. The RT-qPCR-based assay identified EGFR variants with high accuracy (overall concordance rate 94.3%) over a broad range of clinical sample types, variant allele frequencies, tumor cell contents and deoxyribonucleic acid (DNA) input amounts. Conclusions: This study demonstrates that the EasyPGX® ready EGFR assay is a valid approach for the rapid detection of common EGFR variants in real-world clinical NSCLC samples with DNA inputs as low as 5 ng (less than the 15 ng recommended by the manufacturer), improving sample management in small specimens with limited quantity of nucleic acids.
Insights
The EasyPGX® ready EGFR assay accurately detects common epidermal growth factor receptor (EGFR) variants in non-small cell lung cancer (NSCLC) using real-world samples. This rapid, tissue-sparing method works even with low DNA input, improving clinical decision-making.
Area of Science:
- Oncology
- Molecular Diagnostics
- Genetics
Background:
- Activating epidermal growth factor receptor (EGFR) variants are common in non-small cell lung cancer (NSCLC).
- Accurate and rapid detection of EGFR variants is crucial for clinical decision-making in NSCLC.
- Limited tissue samples in NSCLC necessitate tissue-sparing and optimized sample management approaches.
Purpose of the Study:
- To evaluate the performance of the commercial EasyPGX® ready EGFR assay.
- To assess the assay's utility with real-world clinical NSCLC samples.
- To compare the assay's accuracy against next-generation sequencing (NGS).
Main Methods:
- Prospective analysis of 804 non-squamous NSCLC samples.
- Utilized the real-time quantitative polymerase chain reaction (RT-qPCR)-based EasyPGX® ready EGFR assay.
- Compared results with next-generation sequencing (NGS) assays.
Main Results:
- Next-generation sequencing (NGS) provided conclusive results for 99.7% of samples, with 11.1% harboring EGFR variants (common: exon 19 deletions, p.L858R).
- The EasyPGX® assay demonstrated high accuracy (94.3% concordance) across diverse sample types, variant allele frequencies, tumor cell content, and DNA input levels.
- The assay successfully detected EGFR variants with DNA input as low as 5 ng.
Conclusions:
- The EasyPGX® ready EGFR assay is a validated method for rapid detection of common EGFR variants in NSCLC.
- The assay's effectiveness with low DNA input (5 ng) enhances sample management for specimens with limited nucleic acids.
- This approach supports improved clinical decision-making for NSCLC patients.
