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Ventana launches first fully automated IHC companion diagnostic in Europe to identify ALK protein expression in lung cancer patients

-- ALK diagnostic coincides with Pfizer's XALKORI® availability in EU member states

TUCSON, Arizona, Oct. 25, 2012 /PRNewswire/ -- Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, today announced the European launch of the VENTANA ALK immunohistochemistry (IHC) assay as a companion diagnostic for detecting ALK protein expression. The test is designed to identify ALK-positive patients for treatment with Pfizer's approved non-small cell lung cancer (NSCLC) therapy, XALKORI® (crizotinib).  The launch of the VENTANA ALK (D5F3) Rabbit Monoclonal Primary Antibody assay (1) coincides with Pfizer's approval and availability of XALKORI in all EU member states.


Lung cancer is the leading cause of cancer-related death worldwide, 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.

"In line with our mission to improve the lives of all patients afflicted with cancer, our collaboration with Pfizer and the launch of the VENTANA ALK IHC companion diagnostic assay is another strong example of our commitment to enabling Personalized Healthcare for patients worldwide and being the Pharma Partner of Choice," says Mara G. Aspinall, President, Ventana Medical Systems, Inc.

The new VENTANA ALK IHC companion diagnostic assay 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 the VENTANA BenchMark XT and GX instruments.  Immunohistochemistry offers fast interpretation, seamless integration into lab work flow, and the ability to archive test results.

"With the world's largest installed base of IHC automated staining instruments, Ventana intends to offer the VENTANA ALK IHC companion diagnostic assay in all markets where XALKORI is available for therapy, bringing tremendous benefit to physicians and patients worldwide," says Doug Ward, Vice President, Companion Diagnostics, Ventana Medical Systems, Inc.

(1)The VENTANA ALK IHC assay is a CE-IVD, companion diagnostic in Europe.

About Ventana Medical Systems, Inc.
Ventana Medical Systems, Inc. ("VMSI") (SIX: RO, ROG; OTCQX: RHHBY), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. VENTANA solutions are used in clinical histology and drug development research laboratories worldwide. The company's intuitive, integrated staining, workflow management platforms, and digital pathology solutions optimize laboratory efficiencies to reduce errors, support diagnosis and inform treatment decisions for anatomic pathology professionals. Together with Roche, VMSI is driving Personalized Healthcare through accelerated drug discovery and the development of "companion diagnostics" to identify the patients most likely to respond favorably to specific therapies.

VENTANA, the VENTANA logo, and BenchMark are trademarks of Roche.

Visit to learn more.

VMSI Media Relations
Jacqueline Bucher
Senior Director, Corporate Communications
Phone: +1-520-877-7288
e-mail: [email protected]

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