FDA has approved use of the Ventana ALK (D5F3) companion diagnostic from Ventana Medical Systems, Tucson, Ariz, a Roche Group company, on patient tissue specimens processed using the Ventana BenchMark Ultra automated slide stainer. The assay is intended for laboratory use to detect the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded, non-small cell lung carcinoma tissue stained with the Ventana BenchMark XT or Ventana BenchMark Ultra automated immunohistochemical slide stainers. The assay is a companion diagnostic to aid in the identification of ALK-positive lung cancer patients who are eligible for treatment with Pfizer’s FDA-approved therapy, Xalkori (crizotinib). In 2012, the companion diagnostic was certified for commercial release in countries accepting the CE mark; in 2013, it received clearance from the China Food and Drug Administration; in 2015, it received FDA premarket approval as a Class III diagnostic for use on tissues stained using the Ventana BenchMark XT system. The established presence of the BenchMark Ultra system in laboratories globally means that the latest approval expands access for more non-small cell lung cancer patients to benefit from improved treatment options. For more information, visit Roche.