FDA approves Ventana ALK (D5F3) CDx Assay for NSCLC-Ventana Medical Systems

Ventana Medical Systems has announced approval of the Ventana ALK (D5F3) CDx Assay by the FDA as a companion diagnostic to aid in the identification of Non-Small Cell Lung Cancer patients for Pfizer's FDA approved targeted therapy, Xalkori (crizotinib). The Ventana ALK Assay was CE mark approved in Europe in 2012 and was approved by the Chinese Food and Drug Administration in 2013.

With this FDA Class III approval, ALK IHC testing is now widely accessible on Ventana BenchMark immunohistochemistry instruments globally, can be easily integrated into standard lab workflow and offers fast test results with a binary, straightforward scoring method. With an approved ALK IHC test, physicians and their ALK positive patients now have the option to learn their ALK status and start an ALK-targeted therapy within days.

Comment: FDA approval is based on data resulting from collaboration between Ventana and Pfizer. Ventana used the ALK (D5F3) CDx assay and scoring method to retrospectively test patient samples from Pfizer-sponsored clinical trials and demonstrated that the test is effective in identifying patients with ALK-positive NSCLC who may benefit from treatment with Xalkori.