EGFR Mutation Analysis
Alias/Synonym: FDA Approved, T790M
CPT Code: 81235
- Includes:
- Specimen Type, Preferred:
- Formalin fixed paraffin embedded tissue
- Specimen Type, Alternate:
- Sample Quantity, Preferred:
- 1 Block
- 8 Slides
- Sample Quantity, Minimum:
- 1 Block
- 5 Slides
- Transport Container:
- Unstained slides
- Paraffin block
- Transport Temperature:
- Room temperature
- Collection Instructions:
- Charged slides should be cut at 4-5 microns thick.
- Specimen Stability:
- Room temperature: Indefinite
- Rejection Criteria:
- Frozen
- Clinical Significance:
- Detects mutations at p.G719 in exon 18, exon 19 deletions, p.T790M, p.S768I and insertions in exon 20, and p.L858R and p.L861Q in exon 21 of the EGFR gene.
- Limitations:
- This test is designed to detect gene mutations only. It is not intended to detect copy number changes or gene rearrangements.
- Turnaround Time:
- 7 - 10 day(s)
- Reference Ranges:
- Cutoff value % based on assay sensitivity