Roche announces FDA approval of companion diagnostic to identify ALK positive non-small-cell lung cancer patients

Roche

 1 June 2017 - The Ventana ALK CDx assay identifies ALK positive non-small-cell lung cancer patients eligible for treatment with the Novartis drug Zykadia (ceritinib), expanding current treatment options.

Roche today announced US FDA approval of the Ventana ALK (D5F3) CDx assay as a companion diagnostic to identify ALK positive non-small cell lung cancer patients eligible for treatment with the Novartis drug Zykadia (ceritinib). 

The Ventana ALK (D5F3) assay is the only immunohistochemistry test approved by the FDA as a companion diagnostic for Zykadia.

Read Roche press release

Michael Wonder

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Michael Wonder

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Outcome , US , Device