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Roche Receives CE Mark for NSCLC Drug CDx

NEW YORK (360Dx) – Roche said today that it has obtained CE marking for the Ventana anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with the Novartis drug Zykadia (ceritinib).

The Ventana assay is the only immunohistochemistry test CE marked as a companion diagnostic for Zykadia, Roche said. It identifies ALK-positive NSCLC patients eligible for treatment with the drug. ALK, or anaplastic lymphoma kinase, is an NSCLC biomarker. Its detection and inhibition can help shrink tumors in some ALK-positive patients.

"Expanded use of the Ventana anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody to identify non-small cell lung cancer patients with an ALK-positive mutation allows us to aid clinicians and their patients in identifying appropriate treatment options," Ann Costello, head of Roche Tissue Diagnostics, said in a statement. 

The assay is available for use on Roche's BenchMark immunohistochemistry and in situ hybridization instruments.