Navigation Links
Ventana Receives FDA Clearance for HER2 (4B5) Image Analysis and Digital Read Applications
Date:10/24/2011

TUCSON, Ariz., Oct. 24, 2011 /PRNewswire/ -- Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VENTANA Companion Algorithm HER2 (4B5) for image analysis applications with associated VIRTUOSO software and iScan Coreo Au scanner. Ventana is now the only company with a complete workflow solution for determining HER2 (4B5) expression in breast cancer patients.

The application assists the pathologist in the detection and semi-quantitative measurement of HER2 (4B5) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. While the pathologist is still the ultimate authority in scoring HER2 (4B5) stains, the image analysis application helps ensure consistency and objectivity in interpretation.

When used with the VENTANA PATHWAY anti-HER2 (4B5) Rabbit Monoclonal Primary Antibody, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN (Trastuzumab) treatment is being considered. The 510(k) clearance covers all components of the workflow including the 4B5 clone, slide stainer, detection systems, software and scanner.

"The addition of the Companion Algorithm for HER2 (4B5) to the VENTANA portfolio of products gives pathologists an important tool for assessing HER2 (4B5) expression in breast cancer patients," said Dr. Steve Burnell, lifecycle leader for advanced workflow. "Ventana continues to lead the industry with its commitment to providing customers a complete, optimized solution – including stainers, reagents, scanners and digital pathology software applications - that provides accurate and efficient testing results."

Ventana also received FDA clearance for the digital read application that allows the pathologist to view HER2 (4B5) stained slides as images on a computer monitor with VIRTUOSO software and iScan Coreo Au scanner.

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 products are for in vitro diagnostic use for specific applications, and are research use only for other applications.

VENTANA, the VENTANA logo, PATHWAY, Companion Algorithm, VIRTUOSO 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. Ventana Medical Systems, Inc. Receives First FDA 510(k) Clearance for H. pylori Antibody
2. Medicsight Receives Brazilian State Food and Drug Administration Approval for ColonCAD Software
3. Angiotech receives CE Mark approval of HemoStream(TM) Chronic Dialysis Catheter
4. SGX - Lilly Merger Offer Receives Positive Opinions From Proxy Advisory Firms
5. CV Therapeutics Receives European Approval for the Brand Name Ranexa(R)
6. XTL Biopharmaceuticals Receives Notice of Non-Compliance with Nasdaq Marketplace Rule Due to Changes in Board Composition
7. BMP Sunstone Receives Production License from the SFDA to Manufacture and Market Pediatric Multivitamin Granules in the PRC
8. Biotest Diagnostics Receives FDA Clearance for Full Line of Traditional Blood Bank Reagents
9. Caliper Life Sciences Receives $1.1 Million Task Order from the EPAs ToxCast(TM) Screening Program
10. Omaxe Infrastructure & Construction Private Ltd Receives LoI for Construction of Allopathic Medical College and Associated Hospital at Saharanpur, UP With Construction Value of Approx 250 Crores
11. TorreyPines Therapeutics Receives NASDAQ Deficiency Notice
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... CO (PRWEB) , ... April 29, 2016 , ... ... addressing the necessary fundamentals to transform technology into a viable company, CereScan’s CEO, ... growth. Mr. Kelley, a recognized leader and mentor in the Denver area ...
(Date:4/28/2016)... India , April 28, 2016 ... JT, Stirling, and Brayton Cryocoolers), Service (Technical Support, Product ... and Geography - Global Forecast to 2022", published by ... USD 2.94 Billion by 2022, at a CAGR of ... 70 market data Tables and 94 Figures spread through ...
(Date:4/28/2016)... NY (PRWEB) , ... April 28, 2016 , ... ... has made significant investments in recruiting top industry experts, and expanding its LATAM ... which provides industry-leading tools for clients to manage their clinical trial projects. , ...
(Date:4/27/2016)... ... , ... The Pittcon Organizing Committee is pleased to announce that Charles “Chuck” ... of Committee since 1987. Since then, he has served in a number of key ... for both the program and exposition committees. In his professional career, Dr. Gardner is ...
Breaking Biology Technology:
(Date:3/31/2016)... RATON, Florida , March 31, 2016 ... LEGX ) ("LegacyXChange" or the "Company") ... for potential users of its soon to be launched ... video ( https://www.youtube.com/channel/UCyTLBzmZogV1y2D6bDkBX5g ) will also provide ... the use of DNA technology to an industry that ...
(Date:3/22/2016)... and SANDY, Utah , ... which operates the highest sample volume laboratory in ... Genomics and UNIConnect, leaders in clinical sequencing informatics and ... launch of a project to establish the informatics infrastructure ... NSO has been contracted by the Ontario ...
(Date:3/15/2016)... March 15, 2016 Yissum Research Development ... technology-transfer company of the Hebrew University, announced today the ... sensing technology of various human biological indicators. Neteera Technologies ... million from private investors. ... the detection of electromagnetic emissions from sweat ducts, enables ...
Breaking Biology News(10 mins):