Navigation Links
Ventana receives approval from China's FDA for first fully automated IHC companion diagnostic identifying ALK protein expression in lung cancer patients
Date:9/11/2013

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) patients1. 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 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.

"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.

1The 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: http://photos.prnewswire.com/prnh/20130911/MM77371-c

VMSI Media Relations
Jacqueline Bucher
Senior Director, Corporate Communications
Phone: 520-877-7288
e-mail: jacquie.bucher@ventana.roche.com


'/>"/>
SOURCE Ventana Medical Systems, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Ventana Receives FDA Clearance for p53 (DO-7) Image Analysis and Digital Read Applications
2. Ventana licenses Gen-Probe IP for measuring ERG protein in prostate cancer patients
3. Ventana Supports World Patient Safety Day, July 25
4. Ventana Medical Systems, Inc. develops first-ever fully automated dual-stain technique for miRNA and protein detection in cancer
5. MedeAnalytics Receives Leadership Award from Ventana Research
6. Ventana and Biocare Medical sign p63 license agreement to aid in the differential diagnosis of benign and malignant prostate lesions
7. Ventana and Barco revolutionize digital pathology viewing experience
8. Ventana and EMC join forces to take digital pathology into the world of Big Data
9. PAREXEL Chief Operating Officer Dr. Mark A. Goldberg Receives Special Recognition Award
10. Leica Biosystems Receives FDA Approval for the Fully Automated Bond Oracle™ HER2 IHC System on the Leica BOND-MAX
11. Nephros Receives 510(k) Clearance for Hemodiafiltration System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... , Net Sales of $1.90 billion represent an increase ... period, and an increase of 1.2% on an adjusted pro ... first quarter were $0.52 reported, a decrease of 47.5% from ... 29.9% over the prior year period , The Company ... Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) ...
(Date:4/28/2016)... April 28, 2016  ValGenesis, Inc., the ... Solutions (VLMS) today announced that a prominent ... sufferers of chronic kidney failure has selected ... their corporate validation process. The global medical ... solution to manage their validation processes electronically. ...
(Date:4/27/2016)... , Schweiz, April 27, 2016 /PRNewswire/ ... des Sachs CEO Forums in Zürich gab ... ihres führenden Wirkstoffkandidaten STR001 zur Erhaltung des ... eingesetzt wurde, bekannt. Für die umfassende Phase-II-Doppelblindstudie ... und Frankreich angeworben. STR001 wird während der ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... 29, 2016 , ... Melanoma is the deadliest type of skin cancer. Although only about 1 ... skin cancer deaths. More than 10,000 people are expected to die of melanoma this year. ... is the one of the most commonly diagnosed cancers in young women. A recent breakthrough ...
(Date:4/29/2016)... ... April 29, 2016 , ... Reltok Nasal Products proudly announces that Boston ... and neck/ear, nose and throat specialty, has added the KOTLER NASAL AIRWAY™ to its ... is a newly patented safety device secured by nasal surgeons onto the floor ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... Dairy Products, Inc. in an upcoming episode, airing third quarter 2016 via Discovery ... churning cream into butter, Grassland Dairy Products, located in Greenwood, Wisconsin applies product ...
(Date:4/29/2016)... ... April 29, 2016 , ... The infertility specialists at HRC Fertility/Orange County ... Dr. Daniel A. Potter -- are proud of the recent release of their 2014 ... April, SART published the latest verified data for 375 U.S. member clinics. ...
(Date:4/29/2016)... ... 29, 2016 , ... International Dehydrated Foods, Inc. (IDF™) will attend and sponsor ... the Doubletree by Hilton Hotel in Oak Brook, Illinois. The two-day event is the ... protein ingredients. , At the seminar, IDF™ will offer samples of its Savory ...
Breaking Medicine News(10 mins):