Navigation Links
Ventana Medical Systems, Inc. Receives First FDA 510(k) Clearance for H. pylori Antibody
Date:10/4/2011

TUCSON, Ariz., Oct. 4, 2011 /PRNewswire/ -- The VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody (H. pylori) is the first H. pylori antibody to receive 510(k) clearance from the Food and Drug Administration (FDA). Developed by Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, the VENTANA H. pylori antibody, when used in immunohistochemical (IHC) staining, aids in the detection of Helicobacter pylori, a bacterium linked to chronic gastritis, ulcers and stomach cancer.

(Photo:  http://photos.prnewswire.com/prnh/20111004/LA79480)

"FDA clearance of the VENTANA H. pylori antibody proves that our product surpasses the industry standard," says Greg Yap, Ventana lifecycle leader for advanced staining assays. "By leveraging our expertise in industry-leading advanced staining assays and workflow solutions, we are delivering to pathologists another next-generation tool for treating potentially cancer-causing gastric infections.''  

The Centers for Disease Control and Prevention (CDC) estimates that approximately two-thirds of the world's population harbors the H. pylori bacterium, which damages the mucous coating that protects the stomach and duodenum. H. pylori causes peptic ulcers in nine out of 10 instances and studies have shown that those infected with H. pylori are nearly six times more likely to develop gastric cancer than those uninfected. In 1994, the International Agency for Research on Cancer (IARC) classified H. pylori as a carcinogen, or cancer-causing agent.

The VENTANA H. pylori antibody provides pathologists unprecedented views of the bacterium, allowing for a more accurate patient diagnosis. The high contrast staining of the organisms allows pathologists to view more bacteria than can be detected with special stains. With the H. pylori antibody, a pathologist can clearly view the characteristic helical shape of the organism.  Even when very few organisms are present, an infection can be detected and treated effectively.

"As a pathologist with years of hospital experience, I believe our new H. pylori IHC test is an improvement to what is currently available for the diagnosis of H. pylori in tissue," says Dr. June Clements, Ventana staff pathologist. "The clean background and clear staining make identifying the organisms easier and faster. This, along with the specificity, provides the pathologist more confidence in the diagnosis."

For labs, the FDA clearance means less time spent validating the assay and more time running the tests, allowing for better lab workflow and quicker, more accurate patient diagnosis. The H. pylori antibody is also fully integrated with the VENTANA BenchMark XT and BenchMark ULTRA slide staining instruments.

"The key to our success in gaining FDA clearance was working with the FDA early in the process," says Sam Rua, director of regulatory affairs. "We met with the FDA, agreed to an approach for our 510(k) submission and adhered to that approach every step of the process. Because of that alignment, we were ultimately successful in gaining approval for the VENTANA H. pylori antibody."

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 "Smart Systems" – intuitive, integrated staining and workflow management platforms that optimize laboratory efficiencies to reduce errors – support diagnosis and inform treatment decisions for anatomic pathology professionals. Together with Roche, VMSI is driving personalized medicine through accelerated drug discovery and the development of "companion diagnostics" to identify the patients most likely to respond favorably to specific therapies. Visit www.ventana.com to learn more.

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

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


'/>"/>
SOURCE Ventana Medical Systems, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. China Sky One Medical, Inc. Announces Conference Call to Discuss Second Quarter 2008 Results
2. Inverness Medical Innovations Features Innovative TB Diagnostic - Clearview(R) TB ELISA at AIDS 2008
3. ICON Medical Imaging Launches New Service to Boost Reliability of Cardiology Studies
4. Informed Medical Communications Highlights Opportunity in Revised PhRMA Code
5. Concentric Medical(R) Announces Co-Marketing Agreement With InTouch Health(R) to Advance Acute Ischemic Stroke Care
6. BioMS Medical Announces Second Quarter 2008 Results
7. ATS Medical to Participate at the Fourth Annual Noble Financial Equity Conference
8. Mentice, Inc. and the Milwaukee Area Technical College (MATC) Announce Their Partnership in the Area of Procedural Medical Simulation
9. BioMS Medical announces positive interim analysis on phase III trial of dirucotide (MBP8298) for multiple sclerosis
10. Bluestar Silicones Presents Adhesive Gels for Wound Care at Medical Grade Polymers Conference
11. China Sky One Medical, Inc. Develops Nasal Spray for Rheumatic Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... , ... May 25, 2016 , ... ... Fitzmaurice recently became double board-certified in surgery and surgery of the hand by ... Fitzmaurice is no stranger to going above and beyond in his pursuit of ...
(Date:5/25/2016)... , ... May 25, 2016 , ... ... Food and Drug Administration (FDA) has granted the company’s orphan drug designation request ... second orphan drug designation granted by the FDA. , Spinocerebellar ataxia is ...
(Date:5/23/2016)... ... May 23, 2016 , ... The need for blood donations in South Texas and across the ... Texas Blood & Tissue Center, blood donations are on the decline. In fact, donations across ... down 21 percent in South Texas in the last four years alone. , There is ...
(Date:5/23/2016)... ... May 23, 2016 , ... RoviSys, a ... based in Aurora, Ohio, has broken ground on a new building in Holly ... Park area, this new location solidifies a commitment to business in the region. ...
Breaking Biology Technology:
(Date:5/3/2016)... , May 3, 2016  Neurotechnology, a ... the MegaMatcher Automated Biometric Identification System (ABIS) ... large-scale multi-biometric projects. MegaMatcher ABIS can process multiple ... using any combination of fingerprint, face or iris ... MegaMatcher SDK and MegaMatcher Accelerator , ...
(Date:4/26/2016)... LONDON , April 26, 2016 ... EdgeVerve Systems, a product subsidiary of Infosys (NYSE: ... a partnership to integrate the Onegini mobile security ... (Logo: http://photos.prnewswire.com/prnh/20151104/283829LOGO ) The ... enhanced security to access and transact across channels. ...
(Date:4/15/2016)... CHICAGO , April 15, 2016  A ... companies make more accurate underwriting decisions in a ... offering timely, competitively priced and high-value life insurance ... health screenings. With Force Diagnostics, rapid ... and lifestyle data readings (blood pressure, weight, pulse, ...
Breaking Biology News(10 mins):