Navigation Links
Ventana Medical Systems, Inc. Receives FDA Approval for the First Fully Automated Diagnostic Assay for HER2 Gene Status Determination in Breast Cancer Patients
Date:6/14/2011

TUCSON, Ariz., June 14, 2011 /PRNewswire/ -- Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, announced today that the FDA approved the INFORM HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH) for commercialization in the United States. This is the first fully automated assay approved by the FDA for determination of HER2 gene status in breast cancer as an aid in the assessment of patients considered for treatment with Herceptin (trastuzumab).  

For breast cancer patients, waiting days or even weeks for accurate test results can feel like an eternity. Clinicians and patients agree that a rapid, accurate diagnosis enabling them to move forward with a targeted treatment plan is critical. Defining HER2 status allows the treatment team to predict response to Herceptin therapy, which is clinically proven to improve outcomes for patients with HER2-positive breast cancer.

"Ventana and Roche are global leaders in companion diagnostics, including assays for predicting response to Herceptin," said Greg Yap, Ventana's Lifecycle Leader for Advanced Staining Assays. "FDA approval of the HER2 Dual ISH assay is an important milestone benefiting breast cancer patients and diagnostic providers in the U.S. The HER2 Dual ISH assay has been marketed outside the U.S. as a CE marked in vitro diagnostic since 2010 and has quickly become the market leader. Combined with our market-leading PATHWAY HER2 (4B5) immunohistochemistry assay and our complete suite of fully automated diagnostic solutions, we continue to innovate to advance breast cancer testing."

The Ventana HER2 Dual ISH assay transforms the diagnostic process by providing complete, walk-away automation on the VENTANA BenchMark XT instrument and dramatically reducing the turnaround time for accurate results. Today, many labs rely on fluorescent in situ hybridization (FISH) assays to test for HER2 gene amplification. These assays need to be run manually by skilled technologists, making them extremely labor-intensive and time consuming.

The HER2 Dual ISH assay detects both HER2  and chromosome 17 on a single slide using a standard light microscope. Unlike FISH assays, this robust brightfield detection technology delivers a result which is easily interpreted and produces signals that don't fade over time - allowing results to be stored and shared between pathologists.

"By having both signals visible on a single slide using light microscopy, we can determine the HER2 gene status within the morphological context of the tumor," said Eric Walk, M.D., Chief Medical Officer at Ventana. "We believe this adds significant medical value for the patient and is an important advance toward improved patient focused solutions."

About Ventana Medical Systems, Inc.

Ventana Medical Systems, Inc. develops, manufactures, and markets instrument/reagent systems that automate tissue preparation and slide staining in clinical histology and drug discovery laboratories worldwide. The company's Smart Systems for anatomic pathology are important tools used in the diagnosis and treatment of cancer and infectious diseases. Ventana drug discovery systems are used to accelerate the discovery of new drug targets and evaluate the safety of new drug compounds. In addition, the company offers premier workflow solutions designed to improve laboratory efficiency, providing safeguards to enhance the quality of healthcare. Ventana Medical Systems, Inc. is a wholly-owned member of the Roche Group. For more information on Ventana, visit www.ventana.com.

For further information, please contact:
Jacquie Bucher
Ventana Media Relations
520-877-7288  
jacquie.bucher@ventana.roche.com


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

Related medicine technology :

1. Ventana Medical Systems, Inc. Launches Virtuoso Software for Digital Pathology
2. CareGiver, Ventana Medical Systems, Inc. Remote Instrument Support, Has Expanded to Include the Ventana BenchMark ULTRA Automated Stainer
3. Endologix Announces First Clinical Implant of Ventana™ Stent Graft
4. Mindray Medical Receives the 2011 Medical Device Excellence Award for its V Series Patient Monitoring System
5. Symmetry Medical to Present at the 2011 Wells Fargo Securities Healthcare Conference
6. China Medical Technologies Announces the Purchase of its ADSs by Chengxuan in the Open Market
7. Enox Biopharma, Inc. Will Be Granted a Patent for the Delivery of Therapeutic Agents From Within Medical Devices
8. Novelos Therapeutics to Present at the 5th Lippert/Heilshorn Life Sciences & Medical Technologies Virtual Conference on June 16
9. Vertex Plans to Provide Access to Potential CF Therapy VX-770 for Patients with Critical Medical Need
10. Quest Diagnostics Wins Gold Medical Design Excellence Award (MDEA) for Diagnostic Innovation
11. Masimo Pronto-7 Wins GOLD in the 2011 Medical Design Excellence Award Competition—the Premier Awards Program for the Medical Technology Community
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/27/2017)... Biophysics Corporation, a global medical device manufacturer based in ... growth in 2016 when compared to the previous year based ... fueled by its AffloVest® sales in the United ... global sales of surgical product lines. Said H. ... 25 th year in delivering high-quality, innovative medical devices ...
(Date:2/27/2017)... (NASDAQ: IPXL ) today announced that it plans to participate ... James and Associates, 38 th Annual Institutional Investors Conference at ... Cowen and Company 37 th Annual ... Boston, MA. Barclays Global Healthcare ... FL. Individuals may listen to the ...
(Date:2/27/2017)... Israel , Feb. 27, 2017 ... of adult stem cell technologies for neurodegenerative diseases, announced ... M.D., Ph.D., FACP, and Arturo O. Araya , ... "Dr. Almenoff and Mr. Araya are talented and ... time for our company," said Chaim Lebovits , ...
Breaking Medicine Technology:
(Date:2/26/2017)... (PRWEB) , ... February 26, 2017 , ... ... Parkinson’s disease (PD) in persons with a specific LRRK2 mutation, according to a ... , Previous studies have provided evidence of a link between pesticides and incidence ...
(Date:2/24/2017)... ... February 24, 2017 , ... HealthPostures, expert standing desk ... and advantages built into the home office sit stand solution are bold colors, ... to gain the benefits embedded in the TaskMate Go are available 24/7 through ...
(Date:2/24/2017)... ... February 24, 2017 , ... Only two months after the official release of ... in Cannes (France), XO Private has initiated a second print-run of its lavish luxury ... a metre across when open, weighs in at more than six kilos, retails at ...
(Date:2/24/2017)... ... ... An in-depth computational analysis of genetic variants implicated in both schizophrenia and ... may explain why susceptibility to one of the disorders could place individuals at lower ... the journal npj Schizophrenia. , “There is a wealth of genomic data on ...
(Date:2/24/2017)... ... ... Smart Machine Age is here, and it’s disrupting everything. Not only could it drive ... United States may be taken over by technology in the next five to fifteen ... colleagues is drawing to a close. Success will belong to those who can quiet ...
Breaking Medicine News(10 mins):