Navigation Links
Ventana Receives FDA Clearance for p53 (DO-7) Image Analysis and Digital Read Applications
Date:5/7/2012

TUCSON, Ariz., May 7, 2012 /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 p53 (DO-7) image analysis application using the VENTANA iScan Coreo Au scanner and VIRTUOSO software.  Currently, Ventana is the only company offering an FDA-cleared p53 image analysis algorithm for determining p53 expression levels in breast cancer patients.  Ventana is offering the p53 (DO-7) image analysis algorithm in addition to the company's FDA-cleared algorithms for HER2 (4B5), PR (1E2), and Ki-67 (30-9).

"As a market leader and long-term innovator in anatomic pathology, Ventana is committed to improving the lives of cancer patients," says Mara G. Aspinall, President, Ventana Medical Systems, Inc.  "We provide the most clinically-validated, FDA-cleared digital pathology algorithms in the market today.  When you combine this with our broad portfolio of instruments and assays, and our expertise in laboratory knowledge management and workflow, it is clear that Ventana is positioned to deliver the most comprehensive digital pathology solutions available globally."

The p53 (DO-7) image analysis algorithm assists pathologists in the detection and semi-quantitative measurement of p53 (DO-7) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue.  When the p53 (DO-7) algorithm is used in conjunction with the CONFIRM anti-p53 (DO-7) Primary Antibody, it may be used as an aid in the assessment of p53 expression in breast cancer patients (but is not the sole basis for treatment).  The FDA clearance includes all of the components of the VENTANA laboratory workflow solution when used as a system, including the company's BenchMark XT slide stainer, p53 clone DO-7, iView and ultraView DAB detection systems, VENTANA iScan Coreo Au slide scanner, and Virtuoso image management software.

Steve Burnell, PhD, VP, Ventana Digital Pathology and Workflow states, "As is the case for Ki-67, Ventana is the only company offering a 510(k)-cleared algorithm for p53 today. Our increasing Companion Algorithm portfolio of FDA-cleared products is evidence both of our unique capabilities in this field as well as our commitment to empower our customers to deliver the highest standards of patient care through the most robust digital pathology solutions available."

In conjunction with this clearance, Ventana also received FDA clearance for the digital read application that allows pathologists to interpret p53 (DO-7) stained slides as images on a computer monitor using the iScan Coreo Au scanner with VIRTUOSO software.

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. Visit www.ventana.com to learn more.

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

VMSIMedia 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 medicine technology :

1. Ventana Introduces the BenchMark Special Stains Platform
2. Ventana Receives FDA Clearance for Ki-67 (30-9) Image Analysis and Digital Read Applications
3. Ventana Medical Systems, Inc. to Collaborate with Bayer on Companion Diagnostic Test for New Biological Cancer Therapy
4. Syndax Pharmaceuticals Signs Agreement with Ventana Medical Systems, Inc. to Develop Companion Diagnostic Test for Entinostat
5. Ventana Medical Systems, Inc. and Advanced Cell Diagnostics Enter Worldwide Co-Promotion Agreement for Fully Automated RNA In Situ Hybridization Assay Systems
6. Ventana Medical Systems, Inc. Introduces Groundbreaking Laboratory Workflow Integration
7. Ventana Medical Systems, Inc. Unveils High-throughput Slide Scanner for Digital Pathology
8. Ventana Medical Systems, Inc. Receives FDA Approval for the First Fully Automated Diagnostic Assay for HER2 Gene Status Determination in Breast Cancer Patients
9. Ventana Medical Systems, Inc. Launches Virtuoso Software for Digital Pathology
10. CareGiver, Ventana Medical Systems, Inc. Remote Instrument Support, Has Expanded to Include the Ventana BenchMark ULTRA Automated Stainer
11. Endologix Announces First Clinical Implant of Ventana™ Stent Graft
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... -- According to market research "Global Insulin ... Forecast to 2022 - Industry Insights by Type (Insulin ... P&S Market Research, the global insulin delivery device market ... is expected to grow at a CAGR of 6.6% ... is expected to witness the fastest growth at a ...
(Date:5/25/2016)... 2016 Digital Health Dialog, LLC dba ... the US Patent and Trademark Office of U.S. ... processes for electronic opt-­in and processing of discount ... HIPAA compliance and otherwise. Logo - ... "Our technology allows for individuals to opt­-in ...
(Date:5/25/2016)... , May 25, 2016 ... 2016"market research report that provides an overview on ... analysis at various stages, therapeutics assessment by drug ... (RoA) and molecule type, along with latest updates, ... reviews key players involved in the therapeutic development ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... 26, 2016 , ... Eating Recovery Center, Washington ... a brand new child and adolescent residential treatment center on June 1. The ... more specialized eating disorder treatment and access to life-saving care. , To celebrate, ...
(Date:5/26/2016)... ... May 26, 2016 , ... North Cypress Medical ... at Blackhorse Golf Club in Cypress. With the help of community partners, the event ... empowers, and renews hope for wounded service members and their families through health, wellness, ...
(Date:5/26/2016)... ... May 26, 2016 , ... American orthopedic surgeon and ... of Blue Horizon International (BHI), Brian Mehling, M.D., spoke at an International Conference ... 5-6, 2016 in Chicago, IL, USA. Dr. Mehling’s presentation was focused on stem ...
(Date:5/26/2016)... ... May 26, 2016 , ... Eugene Batelli, D.P.M., F.A.C.F.A.S, ... his wonderful accolades and stellar patient reviews, Dr. Batelli continues to be recognized ... Eugene Batelli is a highly trained Podiatric Surgeon who specializes in treating athletes ...
(Date:5/26/2016)... CA (PRWEB) , ... May 26, 2016 , ... ... (also knowns as a bunionette) treatment was more than humbled by customer demand over ... one of their SKU's mid sale. Now that Bunion Bootie has completely replenished its ...
Breaking Medicine News(10 mins):