Navigation Links
Ventana Receives FDA Clearance for Ki-67 (30-9) Image Analysis and Digital Read Applications
Date:2/27/2012

TUCSON, Ariz., Feb. 27, 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 Ki-67 (30-9) image analysis application used with the VENTANA iScan Coreo Au scanner running VIRTUOSO software. Ventana is currently the only company offering an FDA cleared Ki-67 image analysis algorithm for determining Ki-67 expression levels in breast cancer patients.

The Ki-67 protein is known to be an excellent marker for cellular proliferation. The Ki-67 (30-9) application may assist pathologists in achieving objective and consistent Ki-67 interpretation and can provide quantitative results for images with hundreds or thousands of cells.

When the VENTANA Ki-67 (30-9) algorithm is used with the VENTANA CONFIRM anti-Ki-67 (30-9) Rabbit Monoclonal Primary antibody, it may be used as an aid in the assessment of Ki-67 status in breast cancer patients but is not the sole basis for treatment. The 510(k) clearance covers all components of the VENTANA workflow solution used together including the company's BenchMark slide stainer, Ki-67 (30-9) clone, detection systems, slide scanner and image management software.

"Ventana is the only company to offer a 510(k) cleared Ki-67 image analysis solution to pathologists today," said Dr. Steve Burnell, Vice President, Ventana Digital Pathology and Workflow. "This most recent addition to our digital pathology portfolio demonstrates our continued commitment to our customers by providing them with the most advanced clinical pathology workflow solutions available to support the highest standards of patient care."

Ventana also received FDA clearance for the digital read application that allows the pathologist to interpret Ki-67 (30-9) stained slides as images on a computer monitor with the VENTANA iScan Coreo Au scanner and 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 and the VENTANA logo iScan, BenchMark and VIRTUOSO are trademarks of Roche.


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

Related medicine technology :

1. Ventana Medical Systems, Inc. to Collaborate with Bayer on Companion Diagnostic Test for New Biological Cancer Therapy
2. Syndax Pharmaceuticals Signs Agreement with Ventana Medical Systems, Inc. to Develop Companion Diagnostic Test for Entinostat
3. Ventana Medical Systems, Inc. and Advanced Cell Diagnostics Enter Worldwide Co-Promotion Agreement for Fully Automated RNA In Situ Hybridization Assay Systems
4. Ventana Medical Systems, Inc. Introduces Groundbreaking Laboratory Workflow Integration
5. Ventana Medical Systems, Inc. Unveils High-throughput Slide Scanner for Digital Pathology
6. Ventana Medical Systems, Inc. Receives FDA Approval for the First Fully Automated Diagnostic Assay for HER2 Gene Status Determination in Breast Cancer Patients
7. Ventana Medical Systems, Inc. Launches Virtuoso Software for Digital Pathology
8. CareGiver, Ventana Medical Systems, Inc. Remote Instrument Support, Has Expanded to Include the Ventana BenchMark ULTRA Automated Stainer
9. Endologix Announces First Clinical Implant of Ventana™ Stent Graft
10. Watson Receives Complete Response Letter from FDA for Progesterone Vaginal Gel 8%
11. Blue Belt Technologies Receives CE Mark for Navio PFS System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/10/2017)... , May 10, 2017 Global Health Intelligence ... Latin America , published its 2017 ranking of ... is based on extensive data analysis from GHI,s hospitals ... hospitals database for the region. The GHI database covers 86% ... offering more than 130 data points for each institution in ...
(Date:5/9/2017)... WASHINGTON , May 9, 2017  Demonstrating ... the board of directors for the Pharmaceutical Research ... criteria for membership. Biopharmaceutical companies will now have ... in order to be eligible to join PhRMA. ... criteria, the board is sending a clear message ...
(Date:5/6/2017)... , May 5, 2017   Provista , a ... more than 200,000 customers, today announced Jim Cunniff ... wealth of executive and business experience to Provista, including most ... pharmacy in California . He assumed his ... "Jim is a great fit for Provista," says Jody ...
Breaking Medicine Technology:
(Date:5/24/2017)... ... 2017 , ... Medic CE , a Career Step company, is sponsoring ... hosted by the Journal of Emergency Medical Services (JEMS). The free webinar, to be ... by Captain Rommie Duckworth, LP, a career fire captain as well as founder and ...
(Date:5/24/2017)... , ... May 24, 2017 , ... ... prominent for-profit and nonprofit hospitals and health systems in the nation and help ... their institutions, led professional organizations and been instrumental in developing successful hospital and ...
(Date:5/23/2017)... ... , ... Axiad IDS , a leading provider of trusted identities for ... company a “Top 25 Cybersecurity Companies 2017.” Axiad IDS received this honor ... proactively address potential cybersecurity threats before they happen. The annual list of ...
(Date:5/23/2017)... ... May 23, 2017 , ... ... and a 2017 Best in KLAS category winner, has named Daniel P. Bullington ... extend and enhance its technology platform and product offerings,” says Justin Neece, president. ...
(Date:5/23/2017)... ... May 23, 2017 , ... Drs. Allen Huang and Jeffrey ... in Las Vegas, NV, and the importance of treating it immediately. They are ... care for peri-implantitis, with or without a referral. As experienced periodontists and implant ...
Breaking Medicine News(10 mins):