Biocartis Group NV announces the recent publication of a new, large prospective study demonstrating that the Idylla™ EGFR Mutation Test (CE-IVD2) leads to the significant reduction of the time-to-treatment by 48% or on average 16.8 days faster than NGS testing for EGFR positive patients. This shows Idylla™'s potential to improve strategic treatment decisions within a multidisciplinary team for patients with advanced non-small cell lung cancer (NSCLC). The study was performed on 238 samples which were tested both using an NGS panel (Oncopanel) and the Idylla™ EGFR Mutation Test.

The study showed a concordance of 98.7% between the Idylla™ EGFR Mutation Test and the NGS panel. The lab turnaround time was faster for the Idylla™ EGFR Mutation Test by an average of 12.4 days. In the EGFR positive cohort, the Idylla™ EGFR Mutation Test led to a 48% reduction and on average 16.8 days faster turnaround time.

Furthermore, the study concludes that the Idylla™ EGFR Mutation Test could contribute to overall time and cost savings for patients if testing is implemented in a stepwise manner, where the Idylla™ EGFR Mutation Test and the PD-L1 IHC (Immunohistochemistry) test are performed first, and comprehensive yet more expensive NGS panel testing is only initiated in case of a negative Idylla™ EGFR Mutation Test. Such first-line use of Idylla™ EGFR Mutation Test is not only more cost-effective, but it also allows to obtain EGFR test results in the same time frame as the PD-L1 IHC test results, which is important as EGFR positivity may be a contra-indication for PD-1/PD-L1 therapy in NSCLC.