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FISH, EGFR
Test Code19041
CPT Codes
88365
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue
Minimum Volume
4 micron
Other Acceptable Specimens
5X5 mm tumor tissue collected in culture transport medium • 5 micron sections collected on each of 5 charged slides
Instructions
For EGRF determination in solid tumors, only biopsies with histologically proven tumor involvement should be tested. Samples that can be tested include tumor biopsy in tissue culture media, formalin-fixed, paraffin-embedded block, or a minimum of 5 charged/+ slides from formalin-fixed, paraffin- embedded tissue. Specimen must be fixed in 10% neutral buffered formalin. Fixation between 6 and 48 hours is recommended.
Pathology report must accompany paraffin block or slides.
Pathology report must accompany paraffin block or slides.
Transport Temperature
Room temperature
Specimen Stability
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.
Methodology
Fluorescence in situ Hybridization (FISH)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Sets up: Daily; Report available: 5-7 days
Report Available
Reports in 7 days.
Clinical Significance
The epidermal growth factor receptor (EGFR) is a cellular transmembrane receptor with tyrosine kinase enzymatic activity that plays a key role in human cancer. EGFR-dependent signaling is involved in cancer cell proliferation, apoptosis, angiogenesis, invasion and metastasis. Targeting the EGFR is a valuable molecular approach to cancer therapy.
Lung Cancer: Epidermal growth factor receptor (EGFR) Inhibitors have shown promising results in patients with advanced non-small cell lung cancers (NSCLC), who previously have failed on chemotherapy.
Colorectal Cancer: The antiepidermal growth factor receptor (anti-EGFR) monoclonal antibodies, cetuximab and pantiumamab, have good clinical activity in about 10% of patients with metastatic colorectal cancer that is resistant to chemotherapy.
Breast Cancer: EGFR levels were examined by radioligand binding assays in 846 patients with invasive breast cancer. The median follow-up period was 50 months. There was a wide variablility of EGRF levels among the studied tumors (0.01-403 fmol/mg protein).
Lung Cancer: Epidermal growth factor receptor (EGFR) Inhibitors have shown promising results in patients with advanced non-small cell lung cancers (NSCLC), who previously have failed on chemotherapy.
Colorectal Cancer: The antiepidermal growth factor receptor (anti-EGFR) monoclonal antibodies, cetuximab and pantiumamab, have good clinical activity in about 10% of patients with metastatic colorectal cancer that is resistant to chemotherapy.
Breast Cancer: EGFR levels were examined by radioligand binding assays in 846 patients with invasive breast cancer. The median follow-up period was 50 months. There was a wide variablility of EGRF levels among the studied tumors (0.01-403 fmol/mg protein).
