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New Blood ''Signature'' Test Holds Key to Successful Early Alzheimer's Diagnosis and Treatment

Posted on: Sunday, 10 June 2007, 15:00 CDT

Leading experts agree that there is a clear need for a simple blood test for early Alzheimer's disease. Early accurate diagnosis would enable the new generation of Alzheimer's drugs to be successfully administered in the decisive first stages of the disease. Scientists working for Norwegian biotech company DiaGenic ASA are presenting the prototype of and results of initial trials of such a test at the Alzheimer's Association International Conference on Prevention of Dementia in Washington June 9-12, 2007. Using peripheral blood as an easy-to-collect sample, the test detects a unique gene expression profile or "signature". DiaGenic expects the test will be available to researchers in early 2008 paving the way for widespread use.

"The development of a blood-based diagnostic test has been one of the major goals of Alzheimer disease research. The new blood "signature" test of DiaGenic is an important forward step in the right direction. The test is also very timely, as several pharmaceutical companies are in the process of developing the next generation of therapeutic drugs which can inhibit the underlying pathology of Alzheimer disease. The test will require validation in a large number of Alzheimer and control patients, and at multiple centers, to become useful," say leading Alzheimer's researchers, Professors Khalid Iqbal and Bengt Winblad.

The test is the culmination of a major discovery project as researchers combed through many Alzheimer's patient samples and severa thousand genes to identify a common gene signature for Alzheimer's. The most informative genes isolated in these discovery phase studies were then used to design and develop customized test arrays. These prototypes that employ alternate technologies for gene expression profiling have been extensively tested. An entirely new mixed cohort of 100 Alzheimer's disease and age-matched non-Alzheimer's subject samples was employed in these studies. DiaGenic's CEO Erik Christensen commented:" The results now being presented in Washington show that the test can detect Alzheimer's disease with a clinically acceptable accuracy of above 80%. "

DiaGenic now aims to make the test available as a research tool in early 2008. This should accelerate the process of clinical validation and commercial introduction. Recently the FDA approved the first diagnostic test based on this type of technology for another disease (breast cancer), paving the way for establishing Alzheimer's disease gene expression signature in blood as an important diagnostic tool for Alzheimer's disease.

Alzheimer's disease is a progressive brain disorder afflicting approximately 12 million individuals worldwide, with a dramatic rise due to changing demographics forecast to 22-35 million by the year 2025. The symptoms and also the pathology of AD and other forms of dementia are similar and overlapping, making an early and accurate diagnosis extremely difficult. Alzheimer's disease is the most costly disease for our societies - more costly than both cardiovascular disease and cancer combined. In the US alone, direct and indirect costs of caring for AD patients are at least $100 billion.

About DiaGenic ASA

DiaGenic is an innovative Norwegian biotechnology company that seeks to create value for patients, partners, and investors by developing new and more patient friendly methods for early detection of diseases. DiaGenic is currently a world leader in analyzing gene expression signatures related to disease in easily available clinical samples such as peripheral blood. This unique method is based on the principle that even when a disease is localized at a specific part of the body, secondary responses, which are also characteristic of the disease, can be measured in other parts. Significant potential in numerous diseases such as breast cancer and Alzheimer's disease has been identified. The company has been granted patents in the U.S. and Europe. DiaGenic is listed on the Oslo Stock Exchange. For more information visit www.diagenic.com

TaqMan is a registered trademark of Roche Molecular Systems, Inc.


Source: Business Wire

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