Navigation Links
Ventana receives FDA clearance for Estrogen Receptor (ER) Image Analysis and Digital Read Application for breast cancer
Date:12/5/2013

TUCSON, Ariz., Dec. 5, 2013 /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 Companion Algorithm ER (SP1)1 image analysis algorithm used with the VENTANA iScan Coreo scanner running Virtuoso2 software.  With this clearance, Ventana is now the only company in the industry offering a comprehensive portfolio of FDA-cleared image analysis algorithms and digital read applications for the five key immunohistochemistry (IHC) breast markers.  

(Photo:  http://photos.prnewswire.com/prnh/20131205/LA28038)

There are two intended uses obtained with the 510(k) clearance for ER:  first, clinical use of the software algorithm to semi-quantify the ER biomarker, and second, digital read, or clearance to manually read and score the ER biomarker using a computer monitor, in lieu of a microscope. This means the pathologist will be able to digitally view a slide on a computer monitor, assign a score, and then sign out the case with a diagnosis or opinion, with or without the assistance of an image analysis algorithm. 

All IHC breast markers in the Ventana portfolio have both image analysis and digital read application FDA 510(k) clearances. Along with the Companion Algorithm ER (SP1) image analysis software, the full breast panel includes HER2 (4B5), PR (1E2), Ki-67 (30-9) and p53 (DO-7) image analysis algorithms along with their accompanying VENTANA IHC assays3.

"The biomarkers, scanner, and image analysis software have been optimized and clinically validated to work together as a system.  Not only does this provide a po
'/>"/>

SOURCE Ventana Medical Systems, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Ventana to collaborate with Boehringer Ingelheim on the development of companion diagnostic tests
2. Ventana launches first fully automated IHC test to detect BRAF V600E mutation in a variety of cancers
3. UCSB professor receives award for graphene electronics research
4. Watsons Generic Yaz(R) Receives FDA Approval
5. Quanterix Receives Funding From the Department of Homeland Security to Develop Test for Botulinum Toxin
6. Life Technologies Ion Personal Genome Machine Receives San Diegos CONNECT Most Innovative New Product Award
7. MacroGenics Receives Milestone Payment as Part of Its Global DART™ Alliance with Boehringer Ingelheim
8. Intimate Bridge 2 Conception, Inc. Receives $4.3M
9. Pacific Meso Center Receives Generous Donation to First Free-Standing Mesothelioma Research Laboratory in Los Angeles
10. BioNeutral Group Receives $400,000 in Equity Financing
11. Amsterdam Molecular Therapeutics Receives US Orphan Designation for Hemophilia B Gene Therapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/27/2014)... special section on single-photon detection, generation, and applications ... technologies with applications in areas as diverse as ... by providing more accurate measurement methods and new ... SPIE, the international society for optics and photonics, ... , The section appears in the August issue, ...
(Date:9/27/2014)... Texas at Dallas have created technology that could be ... sources or, more immediately, a smartphone that doesn,t die ... technology, published online in Nature Communications ... to control energy consumption inside transistors, which are at ... from the Erik Jonsson School of Engineering and Computer ...
(Date:9/26/2014)... , Sept. 26, 2014 China Cord Blood Corporation (NYSE: ... leading provider of cord blood collection, laboratory testing, hematopoietic ... the Company will hold its 2014 annual general meeting of shareholders ... Bank of China Tower, 1 Garden Road, Central, Hong ... 11, 2014 (8:00 a.m. U.S. Eastern Time on December 11, 2014). ...
(Date:9/26/2014)... Chester, NJ (PRWEB) September 26, 2014 ... of personal selling optimization technology and services for ... will present on Mobile Day at Digital Pharma ... October 21 at 10:30 a.m. , Steven Robinson, ... Director of Client Solutions, will be presenting “Test ...
Breaking Biology Technology:Single-photon detection, generation, and applications featured in Optical Engineering 2Single-photon detection, generation, and applications featured in Optical Engineering 3New UT Dallas technology may lead to prolonged power in mobile devices 2New UT Dallas technology may lead to prolonged power in mobile devices 3China Cord Blood Corporation to Hold Annual General Meeting in Hong Kong on December 11, 2014 2Pursuit to Present at Digital Pharma East 2
... CHARENTON-LE-PONT, France, January 10 Essilor,of America, Essilor ... in the United States with the acquisition,of Interstate ... independent,laboratories. Interstate,s two laboratories in Mansfield, Ohio and,Indianapolis, ... The,company has full-year sales of US$26 million and ...
... of,Maryland, Baltimore (UMB) BioPark today announced that Gliknik ... in the BioInnovation,Center, located in UMB BioPark,s Building ... for autoimmune diseases,and cancer, the foundation of which ... Professor and Chairman of the Department of,Otorhinolarynogology, University ...
... 9 Burrill Merchant Banking acted as,exclusive financial ... partnering of bilastine with the Menarini Group (Italy). ... bilastine rights in Europe,and other regions to Menarini ... is a new highly selective H1 antihistamine for ...
Cached Biology Technology:University of Maryland, Baltimore BioPark Signs Gliknik Inc. as First Tenant in Its BioInnovation Center in Building Two 2Burrill Merchant Banking Advises Faes Farma on Bilastine Licensing Agreement 2
(Date:9/29/2014)... PULLMAN, Wash. Scientists at Washington State University ... specifically, Granny Smith apples may help prevent ... be the first to assess these compounds in ... in October,s print edition of the journal ... apples are a good source of these nondigestible ...
(Date:9/29/2014)... have found compounds that boost liver detoxification enzymes nearly ... placethe crushed seeds left after oil extraction from an ... compounds in Camelina sativa seed, also known ... phytochemicals that work together synergistically far better than they ... supplement because its bioactive ingredients increase the liver,s ability ...
(Date:9/29/2014)... is often deemed inaccessible or esoteric. Yet in the ... in our daily lives and a decisive role in ... behind the scenes. , UC Santa Barbara,s Paul Atzberger, ... assistant professor of mechanical engineering, often works in areas ... research published in the Proceedings of the National ...
Breaking Biology News(10 mins):An apple a day could keep obesity away 2New way to detox? 'Gold of Pleasure' oilseed boosts liver detoxification enzymes 2At the interface of math and science 2At the interface of math and science 3At the interface of math and science 4
... institutions, led by Stanford University and Brown University, have ... federal funding to learn both how the brain and ... can be done to encourage recovery from injury. ... developing the neurotechnology to ultimately enable an entirely new ...
... find answers about ovarian cancer, researchers now have something to ... been using the chicken as a model to study this ... with flaxseed decreases severity of ovarian cancer and increases survival ... of alpha-linolenic acid, one type of omega-3 fatty acid. Several ...
... normally infect rodents, but they are also infectious for ... symptoms in humans. Most importantly, these viruses have an ... any damage to healthy tissue. Therefore, scientists in the ... German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) have been ...
Cached Biology News:New Stanford-led program aims to produce insights into brain injury, recovery 2New Stanford-led program aims to produce insights into brain injury, recovery 3Flaxseed-fed chickens shed light on ovarian cancer 2Flaxseed-fed chickens shed light on ovarian cancer 3Viruses against cancer 2Viruses against cancer 3