Abstract 1205P
Background
Rapid and accurate EGFRm testing is essential to inform treatment decisions for patients with advanced NSCLC. A fully automated, rapid EGFRm diagnostic workflow may decrease turnaround time, allowing faster treatment initiation. This prospective study evaluated the performance and analytical turnaround time (aTAT) of the Idylla™ EGFR Mutation Test, compared with local RM in several real-life workflows.
Methods
Sixteen sites in Belgium, France, Germany and Italy aimed to prospectively test 100 paraffin-embedded biopsy or cytologic tissue samples with ≥10% neoplastic cells from patients with advanced NSCLC. Consecutive sample sections were parallel tested using Idylla™ (5 μm section) and a local RM. RM were targeted next-generation sequencing (NGS, different gene panels), Cobas® EGFR Mutation Test, Sanger sequencing, Pyrosequencing, Sequenom mass spectrometry, Hybrid Capture and Entrogen EGFR Mutation Analysis Kit. Key endpoints were Idylla™ concordance with RM and aTAT (time between lab receipt of sample and result ready by diagnostic test).
Results
To date, data have been collected from 13 sites (n=1245 samples). The overall percent agreement (OPA) for EGFRm detection between Idylla™ and RM (n=1192 valid tests) was 97%, with a positive PA of 87% and a negative PA of 99%. Of the 3% discordances between Idylla™ and RM, 49% were discordant negative (of which 38% were T790M discordant), 27% discordant positive and 24% rare EGFRm that Idylla™ is not designed to detect. 90% of all samples were tested in ≤7 days using the Idylla™ method vs ≤21 days using RM. Differences in mean (±standard deviation) aTAT were observed between RM used, ranging from 4 ±2 days (mass spectrometry) to 23 ±7 days (outsourced NGS). The mean Idylla™ aTAT range between sites was 1 ±1 to 8 ±7 days.
Conclusions
This large, prospective, multi-centre, real-world data set confirms that Idylla™ offers a high OPA and specificity for detecting EGFRm in NSCLC tumour samples vs RM. Idylla™ could be used for a range of lab needs, for example improving aTAT, supporting institutions that do not have access to advanced molecular testing, or use in fast-track testing.
Clinical trial identification
Editorial acknowledgement
We thank Robert Harrison, PhD, from iMed Comms, who provided medical writing support funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca and Biocartis.
Disclosure
M. Hummel: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: F. Hoffmann-La Roche; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre. G. De Maglio: Research grant/Funding (institution): AstraZeneca. E. Watkin: Honoraria (institution), Travel/Accommodation/Expenses: AstraZeneca; Travel/Accommodation/Expenses: MSD; Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: BMS. All other authors have declared no conflicts of interest.