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Ventana receives FDA approval

Ventana Medical Systems has recieved approval of the Ventana ALK (D5F3) CDx Assay by the US Food and Drug Administration (FDA), as a companion diagnostic to aid in the identification of patients for Pfizer's FDA approved targeted therapy, XALKORI (crizotinib).
The Ventana ALK Assay was approved as a CE-IVD in Europe in 2012 and was approved by the Chinese Food and Drug Administration (CFDA) in 2013. With this US FDA Class III approval, ALK IHC testing is now accessible on Ventana BenchMark1 immunohistochemistry (IHC) instruments globally.

"FDA approval of the Ventana ALK (D5F3) CDx Assay is a tremendous accomplishment," says Mary Padilla, MD Senior Director of Pathology and Medical Director for Ventana Companion Diagnostics. "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. Ventana used the Ventana 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 (crizotinib)."


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