Epidermal Growth Factor Receptor (EGFR) Mutation, Cobas V2, Liquid Biopsy
Test Code
Clinical Significance
Epidermal Growth Factor Receptor (EGFR) Mutation, Cobas V2, Liquid Biopsy - The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed below in accordance with the approved therapeutic product labeling:
TARCEVA® (erlotinib) for Exon 19 deletions and L858R in FFPET and plasma TAGRISSO™ (osimertinib) for T790M in FFPET and plasma*
Patients with positive Cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of EGFR exon 19 deletions or L858R mutations are eligible for treatment with certain Tyrosine Kinase Inhibitors (see below).
Patients ...
Test Resources
Test Details
Methodology
Reference Range(s)
Alternative Name(s)
Preferred Specimen(s)
4 mL plasma collected in two K2 EDTA (lavender-top) tubes
Minimum Volume
2 mL
Collection Instructions
Submit 4 mL plasma collected in two K2 EDTA (lavender-top) tubes and separate plasma from blood within four hours of collection time. Shipping on dry ice and maintaining at -70° C at all times is preferred. Specimens may be shipped refrigerated if specimen can be maintained refrigerated and will reach testing lab within 72 hours.
Transport Container
Transport tube
Transport Temperature
Frozen -70° C is preferred, refrigerated acceptable if received within 72 hours
Specimen Stability
- Room temperature: Unacceptable
- Refrigerated: 72 hours
- Frozen -20° C: Unacceptable
- Frozen -70° C: 1 year
Setup Schedule
Refrigerated: 72 hours
Frozen -20° C: Unacceptable
Frozen -70° C: 1 year