Epidermal Growth Factor Receptor (EGFR) Mutation, cobas® v2, Solid Tumor
Also known as: Tarceva, cobas® EGFR Mutation Test v2, EGFR, Tagrisso, erlotinib
Use
This test qualitatively detects defined mutations of the EGFR gene in non‑small cell lung cancer (NSCLC) tumor tissue (FFPE) or circulating tumor DNA in plasma, identifying patients eligible for EGFR‑targeted therapies (e.g., erlotinib for exon 19 deletions and L858R, osimertinib for T790M). Mutational results inform targeted treatment decisions in advanced NSCLC.
Special Instructions
Uses a single kit for both tissue (FFPE) and plasma specimens run concurrently, optimizing workflow. Specimen preparation uses cobas DNA Sample Preparation Kit for tissue and cobas cfDNA Sample Preparation Kit for plasma, processed on the cobas 4800 System.
Limitations
Performance may differ between specimen types; plasma testing may not detect mutations present in tissue (lower sensitivity); patients negative in plasma should have reflex tissue testing. The panel detects 42 mutations across exons 18–21 including T790M, but not beyond these regions.
Methodology
PCR-based (PCR)
Biomarkers
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
Not provided
Minimum Volume
Not provided