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Ventana ALK CDx assay obtains FDA approval to identify lung cancer patients

Roche Group subsidiary Ventana Medical Systems has received approval from the US Food and Drug Administration (FDA) for its ALK (D5F3) CDx assay for use as a companion diagnostic to identify lung cancer patients for Pfizer's FDA approved targeted therapy Xalkori (crizotinib).


Xalkori is an oral first-in-class ALK inhibitor, which is indicated to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

With the US FDA Class III approval, ALK immunohistochemistry (IHC) testing can be used on Ventana BenchMark IHC instruments, which provides better test results with a binary and straightforward scoring method.

Ventana companion diagnostics medical director and pathology senior director Dr Mary Padilla said: "The test provides physicians and patients a fast and accurate method to identify ALK protein expression, and clinicians can be confident knowing that our FDA approval is based on data resulting from collaboration between Ventana and Pfizer."

The Ventana ALK was granted CE-IVD status in Europe in 2012, while obtained approval from the Chinese Food and Drug Administration (CFDA) in 2013.

Roche Tissue Diagnostics president Daniel Zabrowski said: "Traditional fluorescent in situ hybridization (FISH) ALK testing methods have required patients to wait weeks before receiving their ALK mutation status."

Ventana develops and produces instruments and reagents, which automate tissue processing and slide staining for cancer diagnostics.

Image: ALK IHC testing is now widely accessible on Ventana BenchMark IHC instruments with the FDA approval. Photo: courtesy of Ventana Medical Systems, Inc.