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

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
'/>"/>

SOURCE Ventana Medical Systems, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

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:11/26/2014)... 2014 The North America Thermal ... market for detailed analysis of the growth trends ... reach $616.3 million by 2018, growing at a ... Browse through the TOC of the North America ... idea of the in-depth analysis and industry segmentation ...
(Date:11/26/2014)... , Nov. 26, 2014 The announced ... indicate the company is looking to expand in non-healthcare ... sales.  The healthcare market research firm says that  Siemens ... Kalorama Information,s biennial survey of the IVD market , ... any change in its composition would likely affect IVD ...
(Date:11/26/2014)... The Alliance for Safe Biologic ... European physicians at the "1 ST EuropaBio ... at the Spanish Ministry of Health, Social Services ... the Spanish Bioindustry Association (ASEBIO), included regulators from ... oncology and rheumatology societies, representatives from a hospital ...
(Date:11/26/2014)... November 26, 2014 The ETC ... award-winning technology innovation centers, announced today that applications ... on December 1st. “Do you have a big ... I want to know about it. AccelerateBaltimore helps ... to product in just 13 weeks.” Interested ...
Breaking Biology Technology:The North America Thermal Protective Clothing Market is estimated to grow up to $616.3 million by 2018 - Report by MicroMarket Monitor 2The North America Thermal Protective Clothing Market is estimated to grow up to $616.3 million by 2018 - Report by MicroMarket Monitor 3Kalorama: Sale of Three Siemens Healthcare Units Raises Questions About Firm's IVD Future 2ASBM Presents European Physicians Survey at Spanish Ministry of Health 2AccelerateBaltimore Applications to Close in 6 Days 2AccelerateBaltimore Applications to Close in 6 Days 3
... Centers,of America, Inc. (Navitas), the market leader in ... to announce the,appointment of Dean H. Gesme, Jr., ... to currently providing care as a medical oncologist ... as the Past-Chair of the,National Coalition for Cancer ...
... Oct. 17 Monsanto Company (NYSE:,MON) today announced ... president and chief executive officer, and Robb Fraley, ... stock trading,plans in accordance with Rule 10b5-1 of ... plans, the Monsanto executives have directed brokers in ...
... Calif. and OSAKA, Japan, Oct. 17 Affymax,Inc. ... Limited (TSE: 4502),today announced that they have been ... Licensing Executives Society of the U.S. and Canada ... commercialize,Affymax,s lead product candidate, Hematide(TM), for the treatment ...
Cached Biology Technology:Navitas Names Dr. Dean Gesme as Medical Director 2Affymax(R) and Takeda Recognized for Innovative Global Agreement to Develop and Commercialize Hematide(TM) for Anemia 2Affymax(R) and Takeda Recognized for Innovative Global Agreement to Develop and Commercialize Hematide(TM) for Anemia 3
(Date:11/21/2014)... Nov. 20, 2014   Atmel® Corporation (NASDAQ: ... (MCU) and touch technology solutions, today launched the industry,s ... with the widest V cc range from 1.7V ... and faster I 2 C bus communication speeds, and ... memory making them ideal for consumer, industrial, computer, and ...
(Date:11/18/2014)... , Nov. 17, 2014   ... and EMC collaborate to develop The Partners Data ... , The Partners Data Lake will allow researcher ... improve diagnostics, treatment and the lives of patients ... research and clinical activities across the Partners system, ...
(Date:11/18/2014)... , Nov. 18, 2014   EyeLock ... authentication solutions, and MorphoTrust USA (Safran), ... services, today announced a strategic partnership to offer ... motor vehicle administration (MVA), airport screening and financial ... identity-related solutions, MorphoTrust serves consumers through a nationwide ...
Breaking Biology News(10 mins):Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 2Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 3Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 4Partners HealthCare and EMC Unite to Solve Health Care's Toughest Challenges Using Big Data 2Partners HealthCare and EMC Unite to Solve Health Care's Toughest Challenges Using Big Data 3Partners HealthCare and EMC Unite to Solve Health Care's Toughest Challenges Using Big Data 4Partners HealthCare and EMC Unite to Solve Health Care's Toughest Challenges Using Big Data 5EyeLock, MorphoTrust Form Strategic Partnership to Pursue Commercial Enterprise Deployments 2EyeLock, MorphoTrust Form Strategic Partnership to Pursue Commercial Enterprise Deployments 3
... by Yale biologists, of the effects of 1997 El ... the Galpagos Islands, emphasizes the importance of studying populations ... and biological factors make specific populations more vulnerable than ... events provide an ideal system to study the impact ...
... describes hundreds of well-known and respected physicians, scientists, ... or advocated for homeopathic medicine. Eleven U.S. ... Charles Kettering, and C. Everett Koop are among ... benefited from homeopathy. Perhaps most surprisingly is the ...
... CHAMPAIGN, Ill. Using computer simulations, researchers at the University ... driving the molecule back and forth through a nanopore capacitor ... device that would read human genomes quickly and affordably., Being ... (which is the price most insurance companies are willing to ...
Cached Biology News:Global climate change: The impact of El Nio on Galpagos marine iguanas 2The surprising story of Charles Darwin and his homeopathic doctor 2The surprising story of Charles Darwin and his homeopathic doctor 3New technique could dramatically lower costs of DNA sequencing 2
... Invitrogens EvoQuest Services are ... prevail in the current competitive ... proprietary techniques to express, purify, ... your needs: Structure/Function Studies, Activity ...
... Standard Tray (3 per pack), 1. ... and blot processing.Automated staining of Coomassie ... and nucleic acid analysis.Prepares blots for ... detection.Programmable control of protocol, solution, volume, ...
... High quality kits and reagents ... give consistent and reliable 2-D ... up samples from contaminants.Efficiently dialyze ... protein for first-dimension isoelectric focusing.Reagents ...
IMAGEQUANT 300 WKSTN, 1 EA. Category: ImageQuant CCD Imagers....
Biology Products: