New [18F]Flutemetamol Data Presented by GE Healthcare at 7th Annual Human Amyloid Imaging Conference

  New [18F]Flutemetamol Data Presented by GE Healthcare at 7th Annual Human
  Amyloid Imaging Conference

Business Wire

MIAMI -- January 18, 2013

Study data presented by GE Healthcare at the 7^th Annual Human Amyloid Imaging
(HAI) meeting in Miami suggest that GE Healthcare’s electronic training
program (ETP) used to teach interpretation of images taken using the
investigational PET imaging agent [^18F]flutemetamol was highly effective in
training inexperienced readers.

In the study^1, five physician readers (3 nuclear medicine physicians and 2
radiologists) inexperienced in amyloid imaging and independently trained with
the ETP, interpreted 305 [^18F]flutemetamol image sets blinded to patient
information (i.e., a forced choice between normal or abnormal for brain
amyloid). For the 135 patient images for which a standard of truth in regard
to histopathological brain amyloid status was available, the majority read
values for sensitivity, specificity, positive predictive value (PPV), and
negative predictive value (NPV) were 94%, 92%, 87%, and 96% respectively.
Inter-reader agreement was 81% (kappa 0.83). Intra-reader reproducibility was
93% to 100%.

“The results of this study demonstrated that the ETP was highly effective in
training inexperienced readers to read [^18F]flutemetamol PET images with high
NPV and reproducibility, in addition to high sensitivity, specificity, and
PPV, and further supports the potential role of [^18F]flutemetamol in helping
physicians detect amyloid deposits in the brain,” said Jonathan Allis, Ph.D.,
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.”

Earlier this month, GE Healthcare announced that regulatory bodies in the
United States and Europe had accepted for review its marketing applications
for [^18F]flutemetamol. 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. 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 addition to data from the ETP study, 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.

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 ability to detect beta amyloid deposition in living humans.

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 provide quantification, optimized visualization and
reporting tools.

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.

ABOUT GE HEALTHCARE

GE Healthcare provides transformational medical technologies and services that
are shaping a new age of patient care. Ourbroad expertise in medical imaging
and information technologies, medical diagnostics, patient monitoring systems,
drug discovery, biopharmaceutical manufacturing technologies, performance
improvement,and performance solutions services helpsour customers deliver
better care to more people around the world at a lower cost. In addition,
wepartnerwith healthcare leaders, striving toleverage the global policy
change necessary to implementa successful shift to sustainable healthcare
systems.

Our "healthymagination" vision for the future invites the world tojoin 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 Healthcareemployees are committed to serving healthcare
professionals and their patients in more than 100 countries. For more
information about GE Healthcare, visit our web site at www.gehealthcare.com.

For our latest news, please visit http://newsroom.gehealthcare.com

^1 Sherwin P, Wolber J, Longenecker, F, et al. Effectiveness of an electronic
training program to teach interpretation of [18F]flutemetamol PET amyloid
images. Data presented at 7^th Annual Human Amyloid Imaging Meeting, January
16-18, 2013.

Contact:

GE Healthcare
Aleisia Gibson, 609-514-6046 (office)
201-289-3832 (mobile)
Aleisia.gibson@ge.com
or
Scott Lerman, 609-514-6346 (office)
609-937-9253 (mobile)
scott.lerman@ge.com
 
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