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:7/10/2014)... , 11. Juli 2014  Dilon ... für die molekulare Bildgebung, einschließlich molekularer ... die CE-Zulassung für sein Navigator ® ... Dilon das Produkt jetzt europaweit vertreiben. ... Großteil der europäischen Länder ausgedehnt und ...
(Date:7/10/2014)... , July 10, 2014 Integrated Silicon ... in advanced memory and analog IC solutions, today announced ... Thursday, July 24, 2014, at 7:00 a.m. Pacific Time ... results for the fiscal 2014 third quarter ended June ... via telephone, dial 1-888-556-4997 before 6:50 a.m. Pacific time ...
(Date:7/10/2014)... WEST JORDAN, Utah , July 10, 2014 /PRNewswire/ ... imaging solutions, and MiE America , Inc., a ... systems, have entered into a long-term agreement naming BC ... in the US. MiE and BC ... a strategic agreement to establish BC Technical as the ...
Breaking Medicine Technology:Dilon erhält CE-Zulassung für sein Navigator-Gamma-Sondensystem 2BC Technical Partners With MiE America To Be Authorized Provider Of Systems & Service 2
... , HARRISBURG, Pa., Aug. 20 Department of Environmental ... number of West Nile Virus cases has dropped, the threat still ... and make every effort to control mosquitoes and reduce the threat ... number of West Nile cases has substantially decreased in recent years ...
... , , , , ... Stemedica Cell Technologies , Inc. USA, a ... New Drug (IND) meeting with the U.S. Food and Drug Administration ("FDA") ... mesenchymal bone marrow cells (adult human) as a treatment for ischemic stroke. ...
Cached Medicine Technology:DEP Urges Pennsylvanians to Take Precautions to Reduce West Nile Virus Threat 2DEP Urges Pennsylvanians to Take Precautions to Reduce West Nile Virus Threat 3Stemedica Requests Pre-IND Meeting With FDA 2
(Date:7/12/2014)... injuries increase in the summer as people gather around fire ... most vulnerable to these seasonal fire hazards: children. "Young ... by putting their hands on the side of cooking grills," ... Loyola University Medical Center in Maywood, Ill., said in a ... play with fire, you get burned, is true -- ...
(Date:7/12/2014)... “After my mom’s stroke, she loss the use of her ... use of his left side. Eating became a difficult task for ... like them enjoy eating again,” said an inventor, from Fayetteville, N.C. ... HALL PLATE (P C H PLATE). , The PATRICIA CAROL HALL ... eat for individuals who suffer from stroke, experience tremors or loss ...
(Date:7/12/2014)... With prom shopping reaching its final ... is ready to showcase its new and trendy apparels. ... evening dresses in its online shop. Additionally, it is ... these elegant gowns. According to the company’s sales manager, ... 26, 2014. , He says, “Now, worldwide clients ...
(Date:7/12/2014)... “Critical Care Therapeutics in Major Developed ... PCCs and Recombinant Products to Drive Market,” which ... in the US, UK, France, Germany, Italy, Spain, ... of market size for 2013, along with market ... that are being treated using the five major ...
(Date:7/12/2014)... Utah Valley Entrepreneurial Forum Top 25 ... being bestowed to companies in revenue, and pre-revenue startups. ... with recognition for new ideas as well as companies ... , 25 Under 5 highlights outstanding Utah entrepreneurs and ... 5 years old. Award recipients were recognized at their ...
Breaking Medicine News(10 mins):Health News:Burn Injuries More Common in Summer 2Health News:VogueQueen.com Updates Its Summer Collection With New And Trendy Evening Dresses 2Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 2Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 3Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 4Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 5Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 6Health News:SquareHook is Recognized for UVEF 25 Businesses Under 5 Years-Watch Out 2
... new funding from the Bill & Melinda Gates Foundation to ... help agency expand services in 11 new countries, ... world,s largest microfinance organizations, today,announced it has received a $24.2 ... will help Opportunity International,s,subsidiary, the Micro Insurance Agency, greatly expand ...
... Quarter 2008 Sees 52 Percent Increase in Sales from Same ... ... Greenway Medical Technologies,Inc., a leading provider of integrated electronic health records ... its second quarter of fiscal 2008, ending,December 31, 2007, were up ...
... announced it will host a webcast and conference call at 10 am,ET on Friday, ... 2007, which ended December 31. Financial,results are scheduled for release after the market closes ... Robert Holster, Chairman and CEO ... Walter Hosp, SVP ...
... more likely to remain depressed than older men, according to ... the February Archives of General Psychiatry. , The Yale ... while depressed than older men, indicating that women live longer ... likelihood of women becoming depressed and remaining depressed, collectively contribute ...
... constructed with soft lithography, should boost research in which ... screen new pharmaceuticals for potential treatment of parasitic infections ... The tools -- an artificial soil device and a ... easily in a human hand -- are detailed in ...
... Alienation Awareness,Organization (PAAO) is beginning the New Year by ... Parental Alienation Awareness Day., Because most people do ... alienation awareness was put forth to help raise,awareness and ... PAAO is to help the public and professionals become,aware ...
Cached Medicine News:Health News:Opportunity International's Micro Insurance Agency to Develop and Provide Life, Health and Crop Insurance for 21 Million Poor People 2Health News:Opportunity International's Micro Insurance Agency to Develop and Provide Life, Health and Crop Insurance for 21 Million Poor People 3Health News:Opportunity International's Micro Insurance Agency to Develop and Provide Life, Health and Crop Insurance for 21 Million Poor People 4Health News:Opportunity International's Micro Insurance Agency to Develop and Provide Life, Health and Crop Insurance for 21 Million Poor People 5Health News:Greenway Medical Technologies Continues Record Setting Growth 2Health News:Greenway Medical Technologies Continues Record Setting Growth 3Health News:Greenway Medical Technologies Continues Record Setting Growth 4Health News:HMS Holdings Corp. Hosts Fourth Quarter and Full Year 2007 Financial Teleconference and Presentation 2Health News:Older women more susceptible to depression than older men 2Health News:New devices to boost nematode research on neurons and drugs 2Health News:New devices to boost nematode research on neurons and drugs 3Health News:Parental Alienation Awareness Organization Begins Preparations for Parental Alienation Awareness Day - April 25th 2
... 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 ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... 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 ...
Medicine Products: