Evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed, paraffin-embedded tissue of human lung cancer.
J Thorac Dis
; 16(1): 40-50, 2024 Jan 30.
Article
in En
| MEDLINE
| ID: mdl-38410581
ABSTRACT
Background:
Epidermal growth factor receptor (EGFR) mutation detection is essential for the therapy of lung cancer. A sensitive, specific, and cost-effective standardized method to quickly and accurately detect EGFR mutations is urgently needed.Methods:
We evaluated the Idylla™ EGFR Mutation Assay for EGFR mutations in formalin-fixed, paraffin-embedded (FFPE) tumor samples from 232 lung cancer patients, and compared the results with amplification refractory mutation system (ARMS) (n=146) and next-generation sequencing (NGS) (n=86). The surgical tumor sections and cell blocks derived from the same FFPE section were compared. Overall concordance, specificity, sensitivity, cost-effectiveness and turnaround time were compared among the three methods.Results:
The overall concordance between Idylla and ARMS was 89.51% [95% confidence interval (CI) 83.31% to 93.64%] and the specificity of Idylla was 88.68% (95% CI 80.69% to 93.76%). A concordance of 97.67% (95% CI 91.41% to 99.86%) was obtained between Idylla and NGS, the specificity of Idylla was 96.30% (95% CI 86.16% to 99.36%). Compared to the ARMS and NGS, the Idylla™ system significantly reduces the turnaround time. Combining labor, equipment, reagents and time costs, Idylla is more affordable.Conclusions:
Clinically urgent cases with adequate cellularity, can first perform Idylla to detect critical markers, then perform NGS for a comprehensive mutation analysis. Besides, with limited molecular expertise or infrastructure, the Idylla has the potential to extend EGFR testing to more pathology laboratories in primary hospitals.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Language:
En
Journal:
J Thorac Dis
Year:
2024
Document type:
Article
Affiliation country:
China