FDA Approves VENTANA ALK (D5F3) Assay as a companion diagnostic for ZYKADIA.

On June 1, 2017,  Roche (SIX: RO, ROG; OTCQX:RHHBY) announced US Food and Drug Administration (FDA) approval of the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Novartis drug ZYKADIA (ceritinib). The VENTANA ALK (D5F3) Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for ZYKADIA.Continue reading