EGFR PCR reflex to ALK FISH

Tumor tissue in formalin-fixed paraffin embedded block(FFPE) or 5 (4μ thick) unstained paraffin sections on plain glass slides plus 1 H&E stained slide. Cell blocks and cytospins made from FNA (fine Needle aspirates). Cytopathology ThinPrep slides with morphologic correlation. EDTA decal specimens are accepted

EGFR affects tumor growth by modulation of cell proliferation, apoptosis and neovascularization and present in 10-12%, of nonsmall cell carcinomas, primarily adenocarcinomas. EGFR mutants contain increased tyrosine kinase (TK) activity that signals increased cell turnover. Small molecule tyrosine kinase inhibitors (TKIs) currently approved for use in tumors with mutated EGFR include erlotinib (Tarceva). Negative EGFR will automatically reflex to ALK FISH.

Room temperature or refrigerated. Ship in cooled container during summer months.

Tissue not verified for the presence of tumor and specimens fixed in fixatives other than formalin are not acceptable. Samples <10% tumor burden will not be tested, as false negative results cannot be ruled out. Surgical pathology report should be included. Decalcification compromises the specimen quality but PCR is still attempted.

2 years - raw data and DNA. 10 years FFPE

Only tissue that is clearly invasive carcinoma (established by histopathologic criteria) should be tested. Selection of tissue for the PCR assay should be performed by a pathologist.