Roche Holding has obtained approval from the FDA for its Ventana ALK (D5F3) CDx Assay, which is intended for determining which patients may respond to Novartis' non-small cell lung cancer drug Zykadia. The immunohistochemistry test, which can be used on BenchMark IHC/ISH instruments, is also indicated as a companion diagnostic for Pfizer's ALK inhibitor Xalkori.
FDA OKs Roche's companion Dx assay for Novartis' lung cancer drug
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