PRESS RELEASE: 2 February 2021,
New US Studies Demonstrate Idylla™ Allows Rapid First Assessment of Most Common EGFR Mutations Preceding Next-Generation Sequencing
EGFR or ‘Epidermal growth factor receptor’ mutations are the second most common oncogenic driver in non-small cell lung cancer (NSCLC).
The first study2 used a multi-test approach for rapid EGFR testing with the Idylla™ EGFR Mutation Assay (RUO1), followed by NGS. The study included 301 cytologic samples of which 218 were tested with the Idylla™ EGFR Mutation Assay (RUO), resulting in 24.3% (53/218 samples) that were EGFR-mutation positive. Concurrent NGS testing3 showed 96.2% concordance and improved to 98.7% after incorporation of manual review criteria4. This study concluded that Idylla™ testing allows for rapid and accurate determination of EGFR status with low sample input and different sample types, without compromising subsequent more comprehensive NGS testing in cases where further testing is needed.
In the second study5 with 1,249 samples, 98.57% (69/70) showed concordance with the reference methods. Of 1,179 clinical cases, 23.41% were EGFR positive by Idylla™. Concurrent NGS6 testing showed concordance of 98.62% (788/799) and 98.50% (787/799) using MSKCC’s in-house and Idylla™ analysis pipelines, respectively7. The study concluded that a first assessment of the most common EGFR mutations can be performed rapidly with the Idylla™ platform, while, in cases where further testing would be needed, comprehensive NGS testing remains possible for the vast majority of samples, with high success. The average turnaround time for the Idylla™ EGFR Mutation Assay (RUO), from receipt of material to report sign-out, was within three days, even accounting for extra steps of extraction and library preparation in small samples.
Herman Verrelst, Chief Executive Officer of
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1 RUO = Research Use Only, not for use in diagnostic procedures
2 Arcila ME, Yang S-R, Momeni A, Mata DA, Salazar P, Chan R, Elezovic D, Benayed R, Zehir A, Buonocore DJ, Rekhtman N, Lin O, Ladanyi M, Nafa K, Ultra-Rapid EGFR Mutation Screening Followed by Comprehensive Next-Generation Sequencing: A Feasible, Informative Approach for Lung Carcinoma Cytology Specimens with a High Success Rate., JTO Clinical and Research Reports (2020), doi: https://doi.org/10.1016/j.jtocrr.2020.100077., available online
3 On 96.4% of these samples
4 To supplement automated calling, resulting in a diagnostic sensitivity of 95.6% (95% CI, 84.9% to 99.5%). In all, 9 % (14/159) of the cases tested by NGS had EGFR mutations not covered by the Idylla™ assay, primarily insertions in exon 19 and 20 and minor mutations co-occurring with canonical sensitizing mutations
5 Arcila ME et al., Rapid EGFR Mutation Detection Using the Single-Institution Experience of 1200 Cases Analyzed by an In-House Developed Pipeline and Comparison with Concurrent Next-Generation Sequencing Results Idylla Platform, J Mol Diagn 2020, Published on
6 Successfully performed on 94.9% (799/842) of the samples
7 Discordances involved mutations missed by both assays associated with low tumor/low input. Incorporating a manual review algorithm to supplement automated calls improved accuracy from 98.62% to 99.37% and sensitivity from 94.68% to 97.58%
8 De Luca et al,
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