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Ventana Receives Approval From China's FDA For First Fully Automated IHC Companion Diagnostic Identifying ALK Protein Expression In Lung Cancer Patients

TUCSON, Ariz., Sept. 11, 2013 /PRNewswire/ --  Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, today announced the approval of the VENTANA ALK immunohistochemistry (IHC) assay by the Chinese Food and Drug Administration (CFDA) as a companion diagnostic to aid in the identification of patients for Pfizer's CFDA-approved oncology product XALKORI® (crizotinib). The VENTANA ALK (D5F3) Rabbit Monoclonal Primary Antibody assay is designed to identify ALK-positive patients in non-small cell lung cancer (NSCLC) patients 1. The approval is based on a retrospective study that included 1100 Chinese subjects across three national hospitals where the VENTANA assay demonstrated 99.23 percent concordance with Abbott's Vysis ALK Break Apart FISH Probe Kit.

Positive Case of lung tissue stained for ALK

Lung cancer is the leading cause of cancer-related death worldwide and in China, 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® 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 locally advanced or metastatic ALK-positive NSCLC.

"I am delighted with the successful product registration of ALK IHC in China," says Fatt Heng Wong, GM, Roche Diagnostics China.  "It allows us to offer our customers ALK diagnostic testing in non-small cell lung cancer—one of the most prevalent and deadly cancers in China—as part of our active pursuit of Personalized Healthcare initiatives through new innovative products."

The VENTANA ALK IHC companion diagnostic assay, available in over 53 countries, provides patients and lab professionals a highly efficient, standardized, and cost effective testing method for the assessment of ALK protein expression. In addition, the VENTANA ALK IHC assay is the only CE-marked IVD IHC test with a claim to identify patients eligible for XALKORI treatment. IHC interpretation using brightfield microscopy is widely accessible on over 4,000 VENTANA BenchMark XT and GX instruments globally.  Immunohistochemistry offers fast interpretation, seamless integration into lab workflow and the ability to archive test results.

"Approval of the VENTANA ALK assay in China is a tremendous accomplishment and will provide physicians and patients a best-in-class and cost effective method to identify ALK protein expression. With the world's largest installed base of IHC automated staining instruments and industry-leading pipeline of companion diagnostics, Ventana is positioned to create significant benefits for patients, physicians, laboratories and payers worldwide," says Doug Ward, Vice President, Companion Diagnostics, Ventana Medical Systems, Inc.

The VENTANA ALK assay approval by the CFDA highlights the global strength of Roche Diagnostics.  Ventana closely collaborates with Roche country affiliates, such as Roche Diagnostics China, to complete clinical studies and register IVD products upon approval in countries worldwide.  In addition to Pfizer, Ventana has worked with more than 45 biopharmaceutical partners over the past decade and is currently engaged in over 150 collaborative projects to develop and commercialize companion diagnostics globally.

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