Assessing and Evaluating the Scope and Constraints of Idylla Molecular Assays by Using Different Source Materials in Routine Diagnostic Settings

Abstract

For cancer treatment, diagnostics concerning tumor type and determination of molecular markers in short TAT is critical. The fully automated, real-time PCR-based molecular diagnostic Idylla assays are well established in many laboratories for qualitative detection, short TAT and routine screening of clinically relevant oncogenic mutations. According to the manufacturer, all IVD assays are recommended for use only with FFPE tissue samples of 5–10 µM dissections with at least 10% tumor content. In this study, we tested the performance and accuracy of the IVD assays along with the gene fusion assay (RUO) with different tissue/source materials like isolated DNA/RNA, cryomaterial, etc. The study also included testing archival FFPE tissue sections dating back from 20 years and a performance check for different pan-cancer samples individually. All the assays tested with FFPE sections and gDNA/RNA input showed above 96% accuracy and sensitivity, individually with 100% specificity. The Idylla assays also performed exceptionally well on the archival FFPE tissues, and the use of assays for other solid tumors was also remarkable. The performance test and accuracy of Idylla assays showed high efficiency with certain limitations. For the use of Idylla assays, both qualitative and quantitative applicability of different tumor source materials could produce efficient results in different diagnostic settings within a short TAT.

Robust Performance of the Novel Research-Use-Only Idylla GeneFusion Assay Using a Diverse Set of Pathological Samples with a Proposed 1-Day Workflow for Advanced NSCLC Evaluation

“…Of note, Boppudi et al [28] recently investigated Idylla assays, including the Gene-Fusion Assay, in several tissues and source materials and in archival tissue dating back 20 years. The authors evidenced a 100% specificity, 96.3% sensitivity for specific gene fusion and 80% sensitivity for expression imbalance, while the low quality of the RNA extracted from formalin-fixed paraffin-embedded blocks and hematoxylin-eosin-stained slides failed to demonstrate a specific gene fusion or expression imbalance.…”

New Trends in Pathology: From Cell Morphology to Molecular Medicine

“…Similarly, Fisseler-Eckhoff and colleagues tested the accuracy, sensitivity and specificity of the Idylla IVD assays, describing the performances of these diagnostic tools on DNA/RNA samples, as well as on archival formalin-fixed paraffin-embedded tissues (FFPE) [11]. These automated, rapid molecular analyses also achieved excellent outcomes (100% specificity and accuracy above 96%) with sample types not recommended by the manufacturer.…”