Examples of FDA-approved kitted CDxs are the Roche COBAS 4800 test for BRAF V600E mutation detection as a CDx for vemurafenib (Zelboraf) and the Abbott Vysis ALK Break Apart FISH Probe test to identify ALK-positive NSCLC patients for Pfizer’s approved NSCLC therapy Xalkori (Crizotinib) (108, 109, 113, 125). Here, ALK is linked to non-small cell lung carcinoma.