Oro Valley-based Ventana Medical Systems, part of of Swiss drug giant Roche, has won FDA approval of a companion test for a drug to treat non-small cell lung cancer.
The U.S. Food and Drug Administration approved the Ventana ALK CDx Assay as a companion test to identify certain non-small cell lung cancer patients eligible for treatment with the Novartis drug Zykadia (ceritinib). The Ventana test is the only immunohistochemistry test approved by the FDA as a companion diagnostic for Zykadia.
Ventana-Roche has recieved FDA approval of several companion tests for specific drugs to treat breast, bladder and lung cancers and has development agreements with major drug companies for other companion tests.
