Intended Use
EGFR (epidermal growth factor receptor) gene amplification generally results in increased protein expression in breast carcinomas. About 6% of breast carcinomas show moderate to low-level EGFR amplification associated with genuine EGFR protein overexpression. Studies in non-small cell lung cancer (NSCLC) have shown that EGFR expression is associated with reduced survival, frequent lymph node metastasis, and poor chemosensitivity.
Patient Preparation
- Sample collection: Tumour Tissue Block
- Specimen preparation: Do not freeze or expose to extreme temperatures.
- FFPE Tissue Block: Formalin fix (10 percent neutral buffered formalin) and paraffin-embed tissue (3–4-micron thick sections in positively charged/silanized slides). Fixative duration: 6-48 hours.
- Storage/Transport Temperature: Room temperature.
- Unacceptable Conditions: Paraffin block with no tumor tissue remaining. Specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens. Specimens with fixation delayed for more than one hour. Tissue fixed or less than 6 hours of greater than 48 hours.
- Remarks:
- Stability: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Methodology
Fluorescence in situ Hybridization (FISH)
Sample received to report Turnaround time (TAT)
3 working days
Reference Interval
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Interpretive Data
The most recent WHO classification of Tumours of Hematopoietic and Lymphoid Tissues (Revised 5th edition) is used for interpretation criteria for evaluation.
Resources
- Additional Technical Information
- Test Request Form
Sample Reports
- Enhanced Report
- See report