Lung ALK

Assay	VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody
Technical requirement	OptiView and Amplification on a VENTANA BenchMark instrument ALK kit insert
Status	Companion
Interpretation	Presence of strong granular cytoplasmic staining in tumour cells (any percentage of positive tumour cells). Certain staining elements should be excluded, including: light cytoplasmic stippling in alveolar macrophages cells of neural origin (nerve and ganglion cells) glandular epithelial staining scattered lymphoreticular cells within lymphocytic infiltrate Some background staining also may be observed within normal mucosa in NSCLC (including mucin) and in necrotic tumour areas, which should be excluded from the clinical evaluation. NSCLC interpretation guide

Therapies

ALK status should be demonstrated by at least one validated test: immunohistochemistry (IHC), in situ hybridisation (ISH), and/or Next Generation Sequencing (NGS)*
ALK status should be demonstrated by a validated immunohistochemistry (IHC) test (for NSCLC) and confirmed by a validated fluorescent in situ hybridisation (FISH) tests*

* dependent on treatment regimen

ALK status should be demonstrated by a validated immunohistochemistry (IHC) test (for NSCLC) and confirmed by a validated fluorescent in situ hybridisation (FISH) test.

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