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Epidermal Growth Factor Receptor (EGFR) Mutation, Cobas V2, Liquid Biopsy
Test Code94718
CPT Codes
81235
Preferred Specimen
4 mL plasma collected in each of two K2EDTA tubes
Minimum Volume
2 mL
Instructions
Please submit a total of 4 mL plasma. Plasma should be separated 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.
Frozen at -20° C specimens are not acceptable.
Specimens may be shipped refrigerated if specimen can be maintained refrigerated and will reach testing lab within 72 hours.
Frozen at -20° C specimens are not acceptable.
Transport Temperature
Frozen (-70°C)
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 72 hours
Frozen -20°C: Unacceptable
Frozen -70°C: 1 year
Refrigerated: 72 hours
Frozen -20°C: Unacceptable
Frozen -70°C: 1 year
Methodology
Real-Time Polymerase Chain Reaction
Setup Schedule
Set up: Tues, Thurs, Sat; Report available: 3-5 days
Reference Range
Not detected
Clinical Significance
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 who are negative for these mutations should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.
The Cobas® EGFR Mutation Test v2 is indicated as an FDA approved companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed below:
TARCEVA® (erlotinib)
FFPET and plasma: Exon 19 deletions and L858R
TAGRISSO® (osimertinib)
FFPET and plasma: Exon 19 deletions, L858R and T790M
IRESSA® (gefitinib)
FFPET and plasma: Exon 19 deletions and L858R
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 who are negative for these mutations should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.
The Cobas® EGFR Mutation Test v2 is indicated as an FDA approved companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed below:
TARCEVA® (erlotinib)
FFPET and plasma: Exon 19 deletions and L858R
TAGRISSO® (osimertinib)
FFPET and plasma: Exon 19 deletions, L858R and T790M
IRESSA® (gefitinib)
FFPET and plasma: Exon 19 deletions and L858R
