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 techno
'/>"/>

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

Page: 1 2

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:10/22/2014)... Influenza will affect as many as 200,000 people this year ... as high as 49,000 people.  The main way ... to person in respiratory droplets of coughs and sneezes. ... kills much fewer people each year than the Flu. The ... sweat, saliva, blood and other bodily fluids. The Ebola virus ...
(Date:10/22/2014)... 22, 2014 Sanomedics International Holdings, Inc. (OTCQB: ... Global Research & Data Services, demand for thermometers is ... through 2018, as demand for more accurate digital thermometers ... the world,s largest market for thermometers, and one of ... Sanomedics International Holdings, Inc. Sanomedics International Holdings ...
(Date:10/22/2014)... 22, 2014 Provectus Biopharmaceuticals, Inc. (NYSEMKT: PVCT) ... novel investigational drug for cancer, is designed for injection ... effects. Its oncology focus is on melanoma, breast cancer ... 2 trials of PV-10 as a therapy for metastatic ... atopic dermatitis and psoriasis. This summer, ...
Breaking Medicine Technology:WholeHealth Products is proud to be releasing its Influenza A and B combo test, on the heels of the announcing of its phase 2 completion of the Rapid Ebola Test 2Sanomedics International Holdings Analyst Report: Taking Some Heat by BrokerBank Securities, Inc. 2Provectus Biopharmaceuticals Looks at the Asian Markets: Analyst Coverage by Small Cap Traders 2
... combined provide greater improvement in symptoms than ... Pharmaceuticals, Inc. today announced positive results from ... demonstrating that the combination of Clonicel with ... attention deficit hyperactivity disorder (ADHD) symptoms compared ...
... moment for unique malaria , vaccine approachROCKVILLE, Md., ... the strength of public-private collaboration in tackling international ... support from the PATH Malaria Vaccine Initiative (MVI), ... the first tests in adult volunteers -- of ...
Cached Medicine Technology:Addrenex Pharmaceuticals Reports Positive Results in Second Phase 3 Study of ADHD Medication 2Phase 1 Trial of Whole-Parasite Malaria Vaccine to Begin 2Phase 1 Trial of Whole-Parasite Malaria Vaccine to Begin 3Phase 1 Trial of Whole-Parasite Malaria Vaccine to Begin 4
(Date:10/20/2014)... 20, 2014 With a mere 19 ... Crist made a brief fundraising stop at the ... , Fresh from a debate last night with his ... stage for the first seven minutes because Crist had ... described the incident in one word: "weird." , Before ...
(Date:10/20/2014)... October 20, 2014 The Advocator ... booth at the American Foundation for Suicide Prevention’s (AFSP) ... AFSP is a not-for-profit organization that hosts hundreds of ... from these events are used to help understand and ... and personal relationships as well. , The Advocator ...
(Date:10/20/2014)... 2014 Women’s health specialist, Dr. Amber ... Gynecology of Columbus, Inc., A Division of MaternOhio Clinical ... more than 100,000 patients annually. Dr. Murphy will provide ... stages of a women’s life. She is accepting new ... Westerville and Dublin. , Dr. Murphy offers a wide ...
(Date:10/20/2014)... Indianapolis, IN (PRWEB) October 20, 2014 ... Quick Start, a secure cloud solution that enables ... advantage of the ultimate healthcare-specific customer relationship management ... to meet the unique needs of the healthcare ... healthcare experience for providers and patients by combining ...
(Date:10/20/2014)... Angeles, CA (PRWEB) October 20, 2014 ... fitness expertise, nutritional coaching, corporate wellness programming, authorship, international ... CPT, is excited to announce the release of the ... , After many years of coaching thousands of individuals ... nutrition tracking app that does not require calorie counting ...
Breaking Medicine News(10 mins):Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 2Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 3Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 2Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 3Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 2Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 3Health News:Healthcare Relationship Management (HRM) Leader hc1.com® Launches hc1® Quick Start™ 2Health News:JZ Fitness Nutrition App Launches on iTunes 2Health News:JZ Fitness Nutrition App Launches on iTunes 3
... Colorectal cancer is a leading cause of cancer-related deaths ... every year. But it can be prevented with early ... from North Carolina State University, Mayo Clinic and the ... tool to help colonoscopy facilities operate more efficiently, ultimately ...
... Boston University School of Medicine (BUSM) have concluded that the ... (telangiectasias) as compared to the 532nm wavelength laser. The findings, ... Surgery and Medicine , are the first time these lasers ... open (dilated) blood vessels in the outer layer of the ...
... likely to increase, experts say , TUESDAY, Oct. 6 (HealthDay ... and social phobia are more likely to be addicted to ... computer use is a way of life in the United ... a major public health problem, the Taiwanese study authors say. ...
... The Chicago-based non-profit organization, MRSA Survivors Network launched ... Oct. 1st at Loyola University Chicago with great ... to participate and included MRSA survivors and MRSA ... hospital association officials and state legislators. , ...
... ... Leading health and technology experts gathered recently at the Massachusetts Institute ... to explore advanced medical technologies being used to save lives, reduce ... "Artificial Heart--Past, Current and Future," by Alexander Medvedev, PhD., Vice President, ...
... 6 Through October 31, Breads of the World, the ... National Breast Cancer Awareness Month by offering a Pink Ribbon ... Bing cherries and cranberries. A portion of the proceeds from ... Society. This year Panera Bread has partnered with both The ...
Cached Medicine News:Health News:Study shows how to lower costs, waiting times for colonoscopies 2Health News:BUSM researchers identify better laser for treating facial spider veins 2Health News:Teens With ADHD, Depression Risk Internet Addiction 2Health News:Teens With ADHD, Depression Risk Internet Addiction 3Health News:MRSA Activists Declare MRSA an Epidemic on World MRSA Day 2Health News:Terumo Heart, Inc.'s DuraHeart™ Left-Ventricular Assist System Featured at Future of Health Technology Summit 2Health News:Terumo Heart, Inc.'s DuraHeart™ Left-Ventricular Assist System Featured at Future of Health Technology Summit 3Health News:Pink Ribbon Bagel Returns to Fight for a Cure 2
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: