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FDA approves Ventana ALK (D5F3) CDx Assay

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Nov. 9, 2017Roche has obtained FDA approval for 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 Roche medicine Alecensa (alectinib). It is the only test FDA approved as a companion diagnostic for Alecensa, the company says.

“We are very excited about the companion diagnostic label expansion for the ALK (D5F3) assay. This immunohistochemistry assay will deliver critical information on treatment options for non-small cell lung cancer patients,” Ann Costello, head of Roche tissue diagnostics, said in a statement. “The ability to identify ALK-positive patients very quickly with a simple IHC test ensures that more patients can benefit from targeted therapy.”

The Ventana ALK (D5F3) CDx Assay has been shown in studies to identify more patients that will benefit from an anti-ALK target therapy than fluorescent in situ hybridization testing. It is intended for the qualitative detection of the anaplastic lymphoma kinase protein in formalin-fixed, paraffin-embedded NSCLC tissue stained with a Roche BenchMark XT or BenchMark Ultra automated staining instrument. The assay is indicated as an aid in identifying patients eligible for treatment with Xalkori (crizotinib), Zykadia (ceritinib), or Alencensa.

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