Ventana receives approval from China's FDA for first fully automated IHC
companion diagnostic identifying ALK protein expression in lung cancer
TUCSON, Arizona, Sept. 11, 2013
-- VENTANA ALK (D5F3) IHC assay will aid in the identification of patients for
Pfizer's XALKORI in China
TUCSON, Arizona, 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
^ . 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.
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
"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 ALKIHC 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 over150collaborative projectsto
develop and commercialize companion diagnosticsglobally.
"The success of our collaboration with Pfizer in developing the ALK IHC assay
exemplifies our strategy to enable Personalized Healthcare for patients
worldwide and our commitment to be Pharma's Partner of Choice," says Mara G.
Aspinall, President, Ventana Medical Systems, Inc.
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 http://ventana.com/ to learn more.
^ The VENTANA ALK (D5F3) Rabbit Monoclonal Primary Antibody assay is not
approved in the U.S. and is currently for investigational use only.
Related Links BenchMark XT
Image with caption: "Positive Case of lung tissue stained for ALK." Image
available at: http://photos.prnewswire.com/prnh/20130911/MM77371-a
Image with caption: "Negative Case of lung tissue stained for ALK." Image
available at: http://photos.prnewswire.com/prnh/20130911/MM77371-b
Image with caption: "VENTANA BenchMark XT." Image available at:
VMSI Media Relations Jacqueline BucherSenior Director, Corporate
CommunicationsPhone: +1-520-877-7288 e-mail: email@example.com
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