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Roche’s CDx assay FDA approved for Zykadia

June 19, 2017—The FDA approved Roche’s Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase–positive non-small cell lung cancer patients eligible for treatment with the Novartis drug Zykadia (ceritinib). The Ventana ALK (D5F3) Assay, intended for IVD use, is the only immunohistochemistry test approved by the FDA as a companion diagnostic for Zykadia, according to the company.

“With the FDA’s approval of the expanded use of the Ventana ALK (D5F3) CDx Assay to determine which lung cancer patients are eligible for Zykadia, we are helping clinicians and their patients identify additional treatment options for non-small cell lung cancer,” Ann Costello, head of Roche Tissue Diagnostics, said in a company statement. “This is another example of Roche’s continued commitment to advancing the standard of care for lung cancer patients and personalized medicine.”

The VENTANA ALK (D5F3) CDx Assay is available for use on BenchMark IHC/ISH instruments.

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