FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Clears Roche’s Companion Diagnostic to Identify ALK-Positive Non-Small Cell Lung Cancer

June 5, 2017
A A

Roche has been granted FDA clearance of the Ventana ALK (D5F3) CDx assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Novartis drug Zykadia.

Ventana ALK (D5F3) CDx assay is intended for the qualitative detection of the anaplastic lymphoma kinase 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 patients eligible for treatment with Xalkori or Zykadia. — Cynthia Jessup

View today's stories