Skip to main content
Premium Trial:

Request an Annual Quote

Roche ALK Test Gains FDA Approval as CDx for Alecensa

NEW YORK (360Dx) –  Roche said today that the US Food and Drug Administration has approved its Ventana ALK (D5F3) companion diagnostic as an aid in identifying ALK-positive non-small cell lung cancer patients who would benefit from treatment with the firm's drug Alecensa (alectinib).

"This immunohistochemistry assay will deliver critical information on treatment options for non-small cell lung cancer patients," Ann Costello, head of Roche tissue diagnostics, said in a statement. "The ability to identify ALK-positive patients very quickly with a simple IHC test ensures that more patients can benefit from targeted therapy."

The detection and inhibition of the ALK biomarker found in NSCLC can help shrink tumors in some ALK-positive patients, the firm added.

The Ventana ALK (D5F3) CDx is available for use on the Roche BenchMark XT or BenchMark Ultra IHC/ISH slide staining systems.

The ALK test also gained FDA approval in June 2017 as a CDx to identify best responders to Novartis' NSCLC drug Zykadia (ceritinib) in June 2017, and gained FDA approval in June 2015 as a CDX to identify NSCLC patients who are likely to respond well to Pfizer's Xalkori (crizotinib).