Epidermal Growth Factor Receptor (EGFR) Mutation, Cobas V2, Liquid Biopsy
Also known as: Tarceva, cobas® EGFR Mutation Test v2, EGFR, Tagrisso, erlotinib
Use
The test is indicated as a companion diagnostic to aid in selecting non-small cell lung cancer (NSCLC) patients for treatment with targeted therapies according to approved therapeutic product labeling, including TARCEVA® (erlotinib) for Exon 19 deletions and L858R, TAGRISSO™ (osimertinib) for Exon 19 deletions, L858R and T790M, and IRESSA® (gefitinib) for Exon 19 deletions and L858R; patients negative for mutations in plasma should be reflexed to routine biopsy and testing using FFPET specimens.
Special Instructions
Not provided.
Limitations
Not provided.
Methodology
PCR-based (PCR)
Biomarkers
Result Turnaround Time
4-6 days
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
4 mL plasma collected in each of two K2 EDTA tubes
Minimum Volume
2 mL (x2)
Container
K2 EDTA tubes
Collection Instructions
Plasma should be separated from blood within four hours of collection time.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Unacceptable |
| Refrigerated | 72 hours |
| Frozen | Frozen (-70°C): 1 year; Frozen -20°C: Unacceptable |