Laboratory Test Information Guide

Details for EGFR ctDNA

Test Name: EGFR ctDNA
Alternate Name(s): ctDNA EGFR
Laboratory: Molecular Diagnostics
Specimen Type: Plasma
Collection Information: Must be collected in STRECK cell free DNA blood collection tube or other plasma DNA preservation tube.
Test Schedule: As required
Turnaround time from when specimen
is received in testing laboratory:
15 days
10 days
Reference Range: See report
Effective Date: 2019-06-03
Revised Date:  
Critical Value: N/A
Interpretive Comments: The cobas® EGFR Mutation Test v2 is an automated molecular assay designed to detect the presence of mutations in the epidermal growth factor receptor (EGFR) gene in cancer-spreading (metastatic) non-small cell lung cancer (NSCLC). In normal tissue, the EGFR protein transmits signals in cells to regulate cell growth and cell death. Mutations in the EGFR gene result in abnormal functioning of the EGFR protein and stimulate cancer cell growth in NSCLC. The cobas® EGFR Mutation Test v2 is to aid physicians in selecting patients with metastatic NSCLC with specific EGFR treatment mutations (i.e., exon 19 deletions and exon 21 L858R substitution mutations) in plasma specimens, also called liquid biopsy specimens, and also identify presence of the acquired EGFR TKI inhibitor treatment resistance related T790M mutation.
Special Processing: Sample must be collected in stabilizing blood collection tube specific for cell free DNA analysis.
Method of Analysis: Methodology: ctDNA is isolated from a patient’s plasma specimen and mixed with reagents that specifically detect, bind to, and make copies of the tumor's EGFR gene. This reaction produces fluorescence, which is then measured to determine presence or absence of the specific EGFR mutations in the plasma specimen.
Critical Information Required: Sensitizing EGFR mutation must be provided prior to circulating tumuor DNA (ctDNA)test being performed. To conclusively determine that the patient is T790M negative, the patient must be assessed through the standard tissue biopsy and molecular testing process.
Storage & Shipment:  
System Codes: 
Referred To:  

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