PRTODAY / NewswireToday Free press release distribution service network

Written by / Agency / Source: General Electric Company

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

GE Healthcare Announces Acceptance of Applications for Review of Investigational Imaging Agent [18F] Flutemetamol in the United States and Europe - New Imaging Agent May Aid in Evaluation of Alzheimer’s Disease - GEHealthcare.com
GE Healthcare Announces Acceptance of Applications for Review of Investigational Imaging Agent [18F] Flutemetamol in the United States and Europe

 

NewswireToday - /newswire/ - Princeton, NJ, United States, 2013/01/08 - New Imaging Agent May Aid in Evaluation of Alzheimer’s Disease - GEHealthcare.com. NYSE: GE

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Medical Services/Equipment Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

GE Healthcare today announced that regulatory bodies in the United States and Europe have accepted its applications for review of the investigational PET amyloid imaging agent [18F]flutemetamol, a positron emission tomography (PET) imaging agent. A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) for [18F]flutemetamol use in the visual detection of beta amyloid in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other cognitive disorders. Additionally, a Marketing Authorisation Application (MAA) was submitted to the European Medicines Agency for [18F]flutemetamol use in the visual detection of beta amyloid in the brains of adult patients who are being evaluated for AD.

“In clinical trials, [18F]flutemetamol imaging demonstrated consistent performance in the visual detection of beta amyloid in the brain when compared with histopathology data,” said William E. Klunk, MD, PhD, Co-director, Alzheimer Disease Research Center, Distinguished Professor of Psychiatry and Neurology at the University of Pittsburgh. “PET scanning with [18F]flutemetamol has the potential to augment the current methods used in the evaluation of patients with symptoms of Alzheimer’s disease.”

The accumulation of beta amyloid in the brain is a key pathological characteristic of AD, which is primarily diagnosed following thorough clinical examinations (i.e., medical history, physical, neurological, psychiatric and neuropsychological exams, laboratory tests and magnetic resonance imaging (MRI) or computed tomography (CT) scans). [18F]Flutemetamol is being studied to determine its potential ability to detect beta amyloid deposition in living humans.

The NDA and MAA submissions are based on data from a series of clinical trials, including Phase III brain autopsy and biopsy studies which showed high sensitivity and specificity for visual image reads as well as strong concordance between [18F]flutemetamol PET images and beta amyloid brain pathology. Data from these studies were presented at the Alzheimer's Association International Conference 2012 (AAIC 2012) in Vancouver and the American Academy of Neurology’s (AAN) 64th Annual Meeting in New Orleans. [i], [ii] The filing also includes data from a recently completed [18F]flutemetamol PET image reader training validation study, results of which will be presented at a scientific forum in coming months.

“Acceptance of these applications further strengthens GE Healthcare’s commitment towards the early and accurate detection of Alzheimer’s disease pathology and to improving the quality of life for patients and their caregivers,” said Jonathan Allis, PhD, General Manager, PET, GE Healthcare Medical Diagnostics. “PET imaging with [18F]flutemetamol has the potential to be part of a larger diagnostic workup that may help doctors rule out Alzheimer’s disease by reliably showing the absence of beta amyloid deposits in patients with unexplained loss of cognitive function.”

GE’S COMMITMENT TO IMAGING RESEARCH
[18F]Flutemetamol is one component of a broad portfolio of investigational diagnostic solutions that GE Healthcare is currently developing in the Alzheimer’s field. GE Healthcare is taking a comprehensive approach to understanding AD through its ongoing research to uncover the causes, risks, and physical effects of the disease. GE Healthcare offers a broad portfolio of imaging resources including cyclotrons and chemistry systems to manufacture PET imaging agents, PET and MR scanners to scan patients, and is developing image analysis software to help physicians interpret the results.

Additionally, GE Healthcare is collaborating with the pharmaceutical industry to assist in their development of the next generation of therapies. To that end, we are working with potential partners in the industry to understand their strategic needs, and helping to provide imaging support for clinical trials of therapeutic agents.

[i] Ikonomovic M, Buckley C, Smith A et al. [18F]Flutemetamol injection PET images reflect brain amyloid levels. Data presented at Alzheimer's Association® International Conference 2012 (AAIC 2012), Vancouver, BC, Canada.

[ii] Wolk D, Gamez J, Sadowsky C et. al. Brain autopsy and in vivo cortical brain biopsy trials show a strong concordance between [18F]Flutemetamol PET and amyloid-β pathology. Poster presented at: 64th Annual Meeting of the American Academy of Neurology, April 21-28, 2012; New Orleans, LA.

Contact
Aleisia Gibson, Global PR Manager
P: +1 (609) 514-6046 - E: aleisia.gibson[.]ge.com.

About GE Healthcare
GE Healthcare (gehealthcare.com) provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our “healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Medical Services/Equipment Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: General Electric Company

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today Visibility Checker

 

Distribution / Indexing: [+] / [Company listed above is a registered member of our network. Content made possible by PRZOOM / PRTODAY indexing services]

 
 
# # #
 
 
  Your Banner Ad showing on ALL
Medical Services/Equipment articles,
CATCH Visitors via Your Competitors Announcements!


GE Healthcare Announces Acceptance of Applications for Review of Investigational Imaging Agent [18F] Flutemetamol in the United States and Europe

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

GE News Center |
Publisher Contact: Scott Lerman - GE.com 
609-514-6346 / 609-937-9253 (mobile) Scott.Lerman[.]ge.com
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any General Electric Company securities in any jurisdiction including any other companies listed or named in this release.

Medical Services/Equipment via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From General Electric Company / Company Profile


Read Medical Services/Equipment Most Recent Related Newswires:

Frost & Sullivan Lauds SnooZeal’s Unique Electrical Stimulation Therapy for Sleep Apnea in the European Market
ZOLL Expands the Rescuer Experience at EMS Today
Traditional Mass Spectrometers Give Way to High-resolution Technologies Such as MALDI-TOF Finds Frost & Sullivan
AccuVein, Inc. Named A Best Place to Work in Medical Sales for Second Consecutive Year
MRI Inventor to Receive the Medtech Innovation Catalyst Award
Ansell Limited Acquires Cleanroom and Healthcare Consumables Manufacturer Nitritex Limited
ZOLL to Showcase Expanded Portfolio of Advanced Resuscitation and Acute Critical Care Technologies at Arab Health 2017
Frost & Sullivan Awards Ansell for Entrenching itself in the Hand Protection Market with its Visionary Products and Technologies
ZOLL RescueNet ePCR Achieves Latest National Compliance Standard
Eye Tech Care Wins Top Honours from Frost & Sullivan for Developing the EyeOP1, the Only Computer-assisted System for Glaucoma Therapy
Frost & Sullivan Recognizes Nuvectra’s Pioneering Spinal Cord Stimulation Product for Chronic Pain Management
GE Healthcare to Commercialize Rapiscan® Outside the US, Canada & Mexico for Increased Access to Heart Exams
Novel Home Care Needs and Customer Preferences Catalyse Growth Opportunities in Mature Cardiac Monitoring Market Finds Frost & Sullivan
Frost & Sullivan Highlights Inspirata's Leading-edge Digital Pathology Solutions that Accelerate Cancer Diagnostics, Monitoring, Treatment
Sparta Systems Broadens Partnership with TrackWise Implementation Specialist Equality Systems

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  JobsWare.com

Visit  La Bella Bakery Artisan Bakery Arizona





 
  ©2017 Newswire Today — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)