DaTSCAN(TM) (Ioflupane I 123 Injection) Recommended in Updated European Guidelines for Diagnosis of Alzheimer's Disease

By Ge Healthcare, PRNE
Wednesday, October 13, 2010

European Federation of the Neurological Societies Cites Utility of DaTSCAN in Differentiating Alzheimer's Disease from Dementia with Lewy Bodies

PRINCETON, New Jersey, October 14, 2010 - GE Healthcare, a unit of General Electric Company (NYSE: GE), today
announced that DaTSCAN(TM) (ioflupane I 123 injection), a radiopharmaceutical
agent intended for use with single photon emission computed tomography
(SPECT) imaging of the brain, has been recommended in updated European
Federation of the Neurological Societies (EFNS) guidelines for the diagnosis
and management of Alzheimer's disease (AD). The guidelines appear in the
October issue of the European Journal of Neurology.(1)

Specifically, the guidelines, which were last issued in 2007(2), note
that SPECT "may increase diagnostic confidence in the evaluation of
dementia," adding that dopaminergic SPECT imaging with DaTSCAN is useful in
differentiating AD from dementia with Lewy bodies (DLB)(1), a neurological
condition that is similar to AD in that it results from the death of nerve
cells in the brain.(3) The EFNS recommendation carries a level A grade of
evidence - the strongest grade assigned in the guidelines - noting that
DaTSCAN can differentiate AD from DLB with sensitivity and specificity of
"around 85%."(1,2)

"As the global population ages and the prevalence of dementia rises, it
will become increasingly important to be able to differentiate Alzheimer's
disease from other types of dementia," said Adrian Holden, EU Head of Medical
Professional Services for GE Healthcare. "Neurologists will therefore become
increasingly reliant on imaging technologies that can accurately yield a
definitive diagnosis. We are pleased that the EFNS has recognized the value
of DaTSCAN in facilitating diagnosis of dementia, particularly with regard to
distinguishing Alzheimer's disease from dementia with Lewy bodies. We hope
the EFNS recommendation results in enhanced provision of timely and
appropriate treatment to patients living with dementia - not only in Europe,
but worldwide."

Dementia is a general term for a group of symptoms - such as loss of
memory, impaired judgment, language difficulty, loss of complex motor skills,
and other cognitive dysfunction - resulting from permanent damage or death of
the brain's nerve cells.(4) An estimated 24 million people around the world -
including 5.4% of those aged 65 or older - are living with dementia; this
figure is expected to double every 20 years to 42 million by 2020 and to 81
million by 2040. Of those living with dementia, 60% live in developing
countries; this percentage is expected to rise to 71% by 2040.(5)

AD is the most common cause of dementia, representing about 60% of all
dementias.(4) An estimated 8.45 million people in Europe and 5.1 million
people in the United States are thought to be living with AD.(6,7) DLB, which
is estimated to account for 10-20% of dementias(8), takes its name from the
abnormal collections of protein, known as Lewy bodies, in the nerve cells of
the brain.(3)

"By specifically mentioning the utility of dopaminergic SPECT brain
scanning (DaTSCAN) in differentiating Alzheimer's disease from dementia with
Lewy bodies in their new guidelines, the EFNS Scientist Panel on Dementia has
underscored the importance of functional (SPECT) neuroimaging in the
diagnostic work-up of patients with dementia," commented John O'Brien, one of
the authors of the guidelines and Professor of Old Age Psychiatry at the
Institute for Ageing and Health at Newcastle University in Newcastle upon
Tyne, U.K. "A timely and accurate diagnosis of dementia provides certainty
for patients and their carers, can reduce their anxiety and allows them to
better plan for the future and understand the symptoms they are experiencing.
Early diagnosis is important as it can improve utilization of healthcare
resources and contribute to improved long-term patient outcomes, while also
potentially reducing the use of inappropriate medications that can sometimes
have serious side effects."

DaTSCAN was granted a Marketing Authorization by the European Commission
in July 2000 for use in detecting loss of functional dopaminergic neurons
(nerve cells in the brain) in patients with clinically uncertain Parkinsonian
syndrome (PS). In July 2006, the European indication was expanded to include
differentiation of probable DLB from AD. DaTSCAN is currently licensed and
distributed in 32 countries, and has been in clinical use for ten years in
more than 300,000 patients worldwide.(9,10)

In March 2009, GE Healthcare submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for DaTSCAN for striatal dopamine
transport (DaT) visualization in the brain of adult patients with suspected
PS. Dopamine is a brain chemical that is classified as a neurotransmitter and
is found in regions of the brain that regulate movement, emotion, motivation,
and pleasure. Due to an unmet clinical need for an imaging agent to assist
physicians in managing patients according to their dopaminergic status, GE
Healthcare was granted "Priority Review" of the DaTSCAN NDA.(9)

ABOUT GE HEALTHCARE

GE Healthcare 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 and
efficiency around the world. Headquartered in the United Kingdom, GE
Healthcare is a US$17 billion unit of General Electric Company (NYSE: GE).
Worldwide, GE Healthcare employs more than 46,000 people 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.

(1) Hort J, O'Brien JT, Gainotti G, et al. EFNS guidelines for the
diagnosis and management of Alzheimer's disease. Eur J Neurol
2010;17(10):1229-1235.

(2) Waldemar G, Dubois B, Emre M, et al. Recommendations for the
diagnosis and management of Alzheimer's disease and other disorders
associated with dementia: EFNS guideline. Eur J Neurol 2007;14:e1-e26.

(3) Dementia with Lewy bodies. Alzheimer's Disease International Web
site. www.alz.co.uk/alzheimers/lewy.html. Updated November 20, 2007.
Accessed September 30, 2010.

(4) About dementia. Alzheimer's Foundation of America Web site.
www.alzfdn.org/AboutDementia/definition.html. Accessed September 30,
2010
.

(5) Ferri CP, Prince M, Brayne C, et al. Global prevalence of dementia: a
Delphi consensus study. Lancet 2005;366:2112-2117.

(6) Packo I. Dementia in Europe Yearbook 2008. Luxembourg: Alzheimer
Europe, 2008.

(7) About Alzheimer's - statistics. Alzheimer's Foundation of America Web
site. www.alzfdn.org/AboutAlzheimers/statistics.html. Accessed
September 30, 2010.

(8) Dementia with Lewy bodies. MedScape eMedicine Neurology Web site.
emedicine.medscape.com/article/1135041-overview. Updated December 23,
2009
. Accessed August 30, 2010.

(9) Transcript from Peripheral and Central Nervous System Advisory
Committee Meeting, August 11, 2009. Rockville, MD: U.S. Food and Drug
Administration, Center for Drug Evaluation and Research, 2009.
www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Dr
ugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM191398.pdf.
Accessed October 12, 2010.

(10) Data on file. GE Healthcare.

Aleisia Gibson, GE Healthcare, +1-609-514-6046, aleisia.gibson at ge.com

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