Identifying non-small cell lung cancers that may benefit from treatment with epidermal growth factor receptor-tyrosine kinase or anaplastic lymphoma kinase inhibitors.
When this test is ordered, EGFR and LCAF testing will always be ordered. The EGFR Gene, Mutation Analysis, 29 Mutation Panel, Tumor, will always be performed. All specimens without an EGFR mutation will be automatically reflexed to LCAF/ALK (2p23), Lung Caner, FISH Tissue at an additional charge. Specimens with an identified EGFR mutation will result in cancellation of the LCAF test. When this test is ordered, slide review will always be performed at an additional charge.
Pathology report must accompany specimen in order for testing to be performed.
Specimens that have been decalcified (all methods); specimens that have not been formalin-fixed, paraffin-embedded
A negative (wild-type) EGFR result does not rule out the presence of a mutation that may be present, but below the limits of detection for this assay (approximately 5%).
A negative (wild-type) EGFR result does not rule out the presence of other activating mutations in the EGFR gene.
Rare polymorphisms exist that could lead to false-negative or false-positive EGFR results.
The ALK FISH test (LCAF) is intended to be used for therapeutic purposes in pulmonary carcinoma. This FISH assay does not rule out other chromosome abnormalities.
While results of these tests may indicate the likely response to epidermal growth factor receptor (EGFR)-or anaplastic lymphoma kinase (ALK)-inhibitor therapies, selection of treatment remains a clinical decision.