Performance of Ultra-Rapid Idylla EGFR Mutation Test in NSCLC and it's potential at clinical molecular screening
MAIN CONCLUSIONS
- Retrospective observational study in which surgically resected NSCLC specimens obtained at two institutions (N = 170) were examined. The Idylla™ EGFR Mutation Test and the Cobas EGFR Mutation Test v2 were performed independently and the results were compared. For discordant cases, the Ion AmpliSeq Colon and Lung Cancer Research Panel V2 was used.
- After the exclusion of five inadequate/invalid samples, 165 cases were evaluated. EGFR mutation analysis revealed 52 were positive and 107 were negative for EGFR mutation in both assays (overall concordance rate: 96.4%). Analyses of the six discordant cases revealed that the Idylla™ EGFR Mutation Test was correct in four cases. Cobas EGFR Mutation Test v2 was correct in two cases and demonstrated a false positive result.
- All stages of NSCLC were included with a majority in early stage (IA:100; IB: 20, II-III:37 and IV:9) in which low failure rate was demonstrated (1 invalid result due to too low quality, also invalid with Cobas).
- The authors suggest a new testing algorithm with Idylla™ first, for both early stage (single-plex EGFR testing needed) and advanced setting (Idylla™ followed by NGS when wild-type results).
- In a cost-trial calculation, the use of Idylla™ EGFR Mutation Test followed by a multi-gene panel test will reduce molecular screening expenses if applied to a cohort with EGFR mutation frequency >17.9%.
- The authors demonstrated the accuracy and potential clinical utility of the Idylla™ EGFR Mutation Test as a molecular screening platform in terms of turnaround time and molecular testing cost if applied to a cohort with a high EGFR mutation incidence.
Idylla EGFR Mutation Test
Within 150 minutes and with less than 2 minutes hands-on time, the fully automated IdyllaTM EGFR Mutation Test covers 51 mutations in exons 18–21 in a single cartridge using only 1 FFPE tissue section from metastatic NSCLC showing a high concordance of >95% compared with reference methods.
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Catalog number: A0060/6
The Idylla™ EGFR Mutation Test contains PlexZyme and PlexPrime. More
Kenichi Suda, Kazuko Sakai, Tatsuo Ohira, Takaaki Chikugo, Takao Satou, Jun Matsubayashi, Toshitaka Nagao, Norihiko Ikeda, Yasuhiro Tsutani, Tetsuya Mitsudomi, Kazuto Nishio. Performance of Ultra-Rapid Idylla™ EGFR Mutation Test in Non-Small-Cell Lung Cancer and Its Potential at Clinical Molecular Screening. Cancers (Basel). 2023 May 7;15(9):2648. doi: 10.3390/cancers15092648.
Idylla™ EGFR Mutation Test contains PlexZyme and PlexPrime. More
Idylla™ Platform is available as an IVD in Europe, the US and many other countries. Idylla™ EGFR Mutation Test is available as an IVD in Europe and many other countries outside the US. Idylla™ EGFR Mutation Test is validated for the use of FFPE tissue in human NSCLC tissue. Idylla™ is available for sale in Europe, the US and many other countries. Please check availability with a Biocartis representative. Biocartis and Idylla™ are registered trademarks in Europe, the US and many other countries. The Biocartis and Idylla™ trademarks and logos are used trademarks owned by Biocartis. © June 2023, Biocartis NV. All rights reserved