OzDx schreef op 21 mei 2021 08:20:
Has anyone read this article published in March this year?
"Rapid EGFR Mutation Detection Using the Idylla Platform: Single-Institution Experience of 1200 Cases Analyzed by an In-House Developed Pipeline and Comparison with Concurrent Next-Generation Sequencing Results"
I've just copied important bits from the article for my note... if anyone's interested
? Incorporation of the Idylla assay did not adversely affect subsequent NGS testing.
? In concordance with our experience, other studies have also shown the suitability of samples other than FFPE tissue for testing by the Idylla system, including cytology samples, decalcified tissue, and extracted DNA
? Although the Idylla EGFR assay is marketed specifically for FFPE tissue, a variety of input materials and samples can be used with the assay, with acceptable performance parameters. This versatility of the assay has been demonstrated in small studies and case reports for even stained cytologic material.
? Comparison of the Idylla results with the concurrent NGS data highlighted several important points. Overall, the automated mutation calls by the Idylla software alone demonstrated high concordance [98.75% (789/799)] with NGS results for the mutations included in the Idylla assay design. The rate of success of the Idylla assay and the concordance rate in this report are in keeping with prior studies, despite the use of more limited tissue and input material other than FFPE. Previous studies report overall concordance rates of 90% to 98% between Idylla and other orthogonal assays.9,24,26,33, 34, 35, 36 As in our experience, most studies have attributed the false-negative results to low tumor content in the sample.
? More importantly, neither the Idylla software nor the in-house automated analysis generated false-positive results. This high specificity means that positive calls do not require confirmation by an alternate test, enabling clinicians to initiate treatment in a timely manner. False-negative calls, however, are more concerning as, even in the context of minimal tissue loading, the Idylla system rarely generates a failure result. Therefore, in the context of limited tissue, any negative result should be interpreted with caution and must be carefully correlated with the total EGFR CQ and the tumor content before issuing a negative report.
? In conclusion, we find that the incorporation of the Idylla system enables streamlined rapid assessment of the most common mutations in non–small-cell lung cancer while still allowing comprehensive NGS assessment for the vast majority of samples with high success. The average turnaround time for this assay from receipt of material to report sign out is under 3 days, even accounting for extra steps of extraction and library preparation in small samples. The development of an in-house analysis pipeline can streamline additional processes in the laboratory, particularly when it incorporates flagging capabilities for borderline cases to prompt additional testing before final reporting. A manual review process, such as the one described herein, may also be easily incorporated in conjunction with the proprietary Idylla software analysis.