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FDA OKs Roche's companion Dx assay for Novartis' lung cancer drug

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.

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