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US FDA approves Roche's lung cancer companion diagnostic

The U.S. Food and Drug Administration approved Roche Holding Ltd.'s VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase-positive non-small cell lung cancer patients eligible for treatment with Novartis AG's Zykadia drug.

The in vitro diagnostic assay will be used to detect the anaplastic lymphoma kinase protein in non-small cell lung carcinoma tissue on BenchMark XT or BenchMark ULTRA automated staining instrument. It is the only immunohistochemistry test approved by the FDA as a companion diagnostic for Zykadia.