Device Dossier
5415219A0270CC - Idylla EGFR Mutation Test
Device Dossier for 5415219A0270CC - Idylla EGFR Mutation Test (CT929 - Acquired genetic alteration IVDs, Class 3, sponsor Abacus dx). ARTG record,…
- GMDN category: CT929 - Acquired genetic alteration IVDs
Intended purpose
The Biocartis Idylla EGFR Mutation Test is an in vitro diagnostic test intended for the qualitative detection of EGFR gene mutations (such as L858R and exon 19 deletions) in formalin-fixed, paraffin-embedded (FFPE) tissue sections from patients diagnosed with human non-small cell lung cancer (NSCLC). The assay is intended to be used by healthcare professionals as a companion diagnostic to aid in selecting NSCLC patients who are most likely to benefit from treatment with Iressa (gefitinib), Tarceva (erlotinib) and Tagrisso (Osimertinib).
Functional description
Fully automated real-time PCR test for EGFR mutations: Exon 18 (G719A/C/S), Exon 19 deletions, Exon 20 (S768I, insertions), Exon 21 (L858R, L861Q). Uses FFPE tumor tissue from NSCLC patients. Cartridges include all reagents for sample prep, amplification, and detection. Idylla™ System integrates sample-to-result workflow via console, instruments, test-specific cartridge and software (TTP). TTP handles processing, detection, analysis, and reporting.