Epidermal Growth Factor Receptor (EGFR) Mutation, Cobas V2, Solid Tumor
Test Code
Clinical Significance
Epidermal Growth Factor Receptor (EGFR) Mutation, Cobas V2, Solid Tumor - Activating mutations in the gene encoding EGFR occur primarily in NSCLC, and result in constitutive activation of the kinase activity of the EGFR protein, thereby contributing to the oncogenic process. The most common EGFR mutations in NSCLC include a variety of deletions in exon 19 and the substitution mutation L858R in exon 21; these mutations collectively constitute approximately 85% of EGFR mutations observed in NSCLC. The Cobas® EGFR Mutation Test v2 (Cobas® EGFR Test) is a real-time PCR assay designed to detect G719X substitution mutations in exon 18, deletion mutations in exon 19, ...
Test Resources
Test Details
Methodology
Reference Range(s)
Alternative Name(s)
Preferred Specimen(s)
Formalin-fixed, paraffin-embedded tissue
Alternative Specimen(s)
10 unstained 5-micron slides AND 1 H&E slide
Minimum Volume
5 unstained slides AND 1 H&E slide
Collection Instructions
Only NSCLC FFPET sections of 5-micron thickness containing at least 10% tumor content by area are to be used in the Cobas® EGFR Test. Any sample containing less than 10% tumor content by area should be macro-dissected after deparaffinization.
Transport Container
Formalin-fixed, paraffin-embedded tissue block
Transport Temperature
Room temperature
Specimen Stability
- Formalin-fixed, paraffin-embedded tissue
- Room temperature: 1 year
- Refrigerated: Unacceptable
- Frozen: Unacceptable
- 5 Micron unstained slides
- Room temperature: 60 days
- Refrigerated: Unacceptable
- Frozen: Unacceptable
Reject Criteria
Baked slides
Setup Schedule
Room temperature: 1 year
Refrigerated: Unacceptable
Frozen: Unacceptable
5 Micron unstained slides
Room temperature: 60 days
Refrigerated: Unacceptable
Frozen: Unacceptable