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Detection of EGFR gene amplification by fluorescence in situ hybridization (FISH) may be demonstrated in different types of cancers. Interpretive criteria for tumors, other than non-small cell lung cancer, have not been established.

Colorectal Cancer
Based on current literature, EGFR gene amplification and/or high polysomy, as measured by FISH testing, are associated with a favorable clinical benefit in patients with CRC who are treated with EGFR-targeted therapies, such as Erbitux^® and Vectibix^®.

Non-Small Cell Lung Cancer
Based on current literature, EGFR gene amplification and/or high polysomy, as measured by FISH testing, are associated with a favorable clinical benefit in patients with non-small cell lung carcinoma (NSCLC) who are treated with tyrosine kinase inhibitors (TKI), such as gefitinib and erlotinib.

The FISH test results should be used in conjunction with other clinical information. The probe used is EGFR-CEP^®7 Dual Color DNA Probe (Vysis^®).

Information Sheet - EGFR Amplification by FISH - NSCLC (PDF)

CPT Codes:

88368(2)

1. Fixed Paraffin Block with Corresponding H&E:
   • Tissue should be in formalin. If alternative fixative is used, it should be noted on the requisition.
   • Store specimen at room temperature (20-23.5° C).
   • Use cold pack for transport. Be sure cold pack is not in direct contact with specimen during transport.
2. Unstained Slides:
   • Send all slides within 6 weeks of cutting.
   • Minimum of 4 slides for FISH testing (include additional slide for Genzyme H&E).
   • Pre-cut slides from paraffin block in 5 micron sections and mounted on Poly-L-Lysine-coated or plus (+) slides.
   • Air dry. Do not oven dry.
   • Store specimens at room temperature (20-23.5° C).

Turnaround Time:

2-3 days

Client Services: Oncology/Pathology   800-447-5816

Specimen Services/Pickup:  877-246-1226