FISH, EGFR

Test Code
19041


CPT Codes
88365

Preferred Specimen
Formalin-fixed paraffin-embedded tissue block


Other Acceptable Specimens
5 x5mm tumor tissue collected in culture transport medium • 5 micron (minimum 4 micron) sections collected on each of (x5) positively 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.

If results are not possible, the test order may be canceled and replaced with a Cytogenetics Communication.


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
Monday-Saturday Morning Report available: 5 Days


Reference Range
See Laboratory Report


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).




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.