VENTANA ALK (D5F3) CDx Assay receives FDA approval

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Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, today announced 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 widely accessible on VENTANA BenchMark immunohistochemistry (IHC) instruments globally, can be easily integrated into standard lab workflow and offers fast test results with a binary, straightforward scoring method.

"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)."

"The success of the VENTANA ALK (D5F3) CDx Assay is an excellent example of Roche's continued commitment to advancing the standard of care for patients," says Dan Zabrowski, President of Roche Tissue Diagnostics (Ventana). "Traditional fluorescent in situ hybridization (FISH) ALK testing methods have required patients to wait weeks before receiving their ALK mutation status. 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."

Lung cancer is the leading cause of cancer-related death worldwide and in the United States, with NSCLC being the most common sub-type. One important biomarker in NSCLC is the anaplastic lymphoma kinase (ALK) fusion gene, which is associated with pathologic expression of an ALK fusion protein. The detection of ALK positivity is very important for NSCLC patients because inhibition of the ALK tyrosine kinase has led to tumor shrinkage for ALK-positive patients. XALKORI® (crizotinib) is an oral first-in-class ALK inhibitor that has been shown to block important growth and survival pathways which may shrink or slow the growth of tumors. It is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Companion diagnostics (CDx) are tests designed to confirm the presence of a specific biomarker to assist physicians in selecting effective therapies for their patients, based on the individual characteristics of each person. Incorporating a companion diagnostic strategy into a drug development program may expedite the drug approval process and help generate more effective treatments with improved safety profiles for patients.

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