The FDA approval of Crizotinib (Xalkori by Pfizer) in 2011 for the therapy of non-small cell lung cancer with translocations in the anaplastic lymphoma kinase (ALK) gene and the concurrently-approved companion diagnostic test (Vysis ALK Break-Apart FISH Probe by Abbott) opened the market for other companion diagnostic, FISH-based assays. The gene discussed is ALK; the disease is non-small cell lung carcinoma.