Diagnostic accuracy of the Idylla™ mutation test for detecting EGFR mutations in non-small cell lung cancer: a...

The epidermal growth factor receptor (EGFR) plays a key role in non-small cell lung cancer (NSCLC) and is fundamental in therapeutic decision-making. The Idylla™ EGFR Mutation Test (Idylla™ MT) is an automated platform designed to detect mutations in EGFR. This meta-analysis evaluates its diagnostic test accuracy (DTA) in comparison with reference methods such as next-generation sequencing (NGS) and real-time PCR (qPCR).

A systematic review was carried out of 27 studies including 10,585 samples from patients with NSCLC. Sensitivity, specificity and other DTA parameters were analyzed using a random effects model. The performance of Idylla™ MT was compared to NGS and other conventional methods, and heterogeneity between studies was evaluated.

The combined sensitivity and specificity of Idylla™ MT were 0.92 (95 % CI: 0.88-0.95) and 1.00 (95 % CI: 0.99-1.00), respectively, with an area under the SROC curve (AUC-SROC) of 0.99, indicating excellent diagnostic performance. Compared to NGS, sensitivity and specificity were similar (0.92 and 1.00, respectively). The prevalence of EGFR mutations detected by Idylla™ MT was 43.1 %, with significant heterogeneity between studies. Its rapid response time allows for more agile clinical decision making.

Idylla™ MT is a precise and cost-effective alternative for the detection of EGFR mutations, especially in resource-limited settings. Its main limitations include restricted mutation detection and possible false negatives in samples with low tumor DNA. Its complementary use with broader molecular techniques is recommended to optimize the detection and management of NSCLC.