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FDA Approves Tool to Identify ALK-Positive NSCLC Patients

Roche news release; 2017 Jun 1

Publish date:: June 6, 2017

The FDA has approved Ventana ALK (D5F3) CDx assay as a companion diagnostic to identify anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with Zykadia (ceritinib) or Xalkori (crizotinib).

The assay is intended for the qualitative detection of the ALK protein in formalin-fixed, paraffin-embedded NSCLC tissue stained with a BenchMark XT or BenchMark Ultra automated staining instrument. It is indicated as an aid in identifying eligible patients, and is intended for in vitro diagnostic use.

Results should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.

Citation:

Roche announces FDA approval of companion diagnostic to identify ALK-positive non-small cell lung cancer patients. [news release]. Silver Spring, MD: FDA. June1, 2017. http://www.prnewswire.com/news-releases/roche-announces-fda-approval-of-companion-diagnostic-to-identify-alk-positive-non-small-cell-lung-cancer-patients-300466815.html. Accessed June 3, 2017.

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