EGFR Mutation Analysis - Cobas® V2 Assay
Also known as: Erlotinib Responsiveness in NSCLC, EGFR Mutation Analysis, cobas® EGFR Mutation Test v2, Osimertinib Responsiveness in NSCLC, EGFR Mutation Analysis, Tagrisso® Responsiveness in NSCLC, EGFR Mutation Analysis, Tarceva® Responsiveness in NSCLC, EGFR Mutation Analysis
Companion Diagnostic
EGFR Mutation Analysis - Cobas® V2 Assay is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
The FDA approved cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from FFPE tumor tissue or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anticoagulated peripheral whole blood. The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in the table below in accordance with the approved therapeutic product labeling:
Special Instructions
Provide a copy of the pathology report or related ICD‑10 code on the requisition to avoid delays. Contact customer service at 800‑345‑4363 for questions.
Limitations
Mutation detection depends on sample integrity and DNA amount. The assay can detect at least 5% mutant DNA (except exon 19 2240_2257del18 which requires >10%) in a background of wild‑type DNA. Sensitivity allows detection of ≤100 copies of mutant DNA per mL plasma using standard input (25 µL DNA stock per reaction well).
FDA ApprovedCompanion Diagnostic
Methodology
PCR-based (PCR)
Biomarkers
Result Turnaround Time
7-10 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Formalin‑fixed, paraffin‑embedded tissue block or four unstained slides and one matching H&E‑stained slide at 5 μM
Minimum Volume
Two unstained slides at 5 μM and one matching H&E‑stained slide
Container
Slides, blocks
Storage Instructions
Room temperature; FFPE blocks stable 12 months at 15‑30 °C; 5‑µm slides stable 60 days at 15‑30 °C
Causes for Rejection
No tumor tissue; tumor cellularity < 10% after macrodissection; broken or stained slides
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Blocks 12 months, slides 60 days |
| Frozen | ≤‑70 °C 12 months |
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