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DiaGenic ASA Presents Breakthrough Data on Development of the First Early Blood Test for Alzheimer's Disease At ICAD

Posted on: Tuesday, 18 July 2006, 12:00 CDT

DiaGenic ASA (OSE:DIAG) today announced that it has achieved important milestones in the development of a diagnostic test for Alzheimer's disease. New scientific data based on gene expression analysis confirms that the development of a simple blood-based test for diagnosing Alzheimer's Disease (AD) is a realistic possibility in the near future, thereby enabling earlier therapeutic intervention. DiaGenic presented its findings at the 10th International Conference on Alzheimer's Disease and Related Disorders (ICAD) in Madrid. ICAD, which is organized by the Alzheimer's Association, is one of the largest gatherings of Alzheimer's disease researchers in the world.

"There are currently no direct tests that confirm Alzheimer's disease in a living person, with diagnosis usually relying on subjective means, such as memory tests," said Professor Bengt Winblad, of the Karolinska Institute, Stockholm, co-founder of ICAD, and renowned AD researcher. "This study clearly demonstrates the potential of DiaGenic's approach towards the development of an early, blood-based diagnostic test with the sensitivity and specificity the AD community is looking and hoping for."

DiaGenic ASA and its collaborative partner, IMGM Laboratories GmbH, Munich, used Applied Biosystems gene expression technology in a research study to identify a gene expression signature characteristic for AD in easily collectable peripheral blood samples. The extensive test set validated study shows clearly that the gene expression signature identified by DiaGenic can distinguish, with high accuracy, individuals with AD from both healthy elderly and younger individuals and also from those with another neurodegenerative disorder, Parkinson disease.

In this extensive study, a set of 330 blood samples, including 125 from patients recently diagnosed with AD, was used to generate a gene expression model for the disease and an independent test set was then used to validate the model. This rigorous validation gave an accuracy of 87%.

"The results represent a major step towards our goal, which is to develop a simple blood-based test that will enable physicians to discriminate between non-AD and AD patients at an early stage." said Dr Anders Lonneborg, CEO of DiaGenic. "We are currently validating the results from the microarray platform on a Real Time PCR platform; TaqMan(R) and have already found that the gene expression signature can be transferred to commercially viable diagnostic platforms. Thus, we expect to be able to have the first product prototype ready for clinical trials by the end of this year."

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

About IMGM Laboratories GmbH

IMGM Laboratories was founded in 2001 as a spin-off from the Department for Clinical Chemistry at the University Hospital of Munich and is located at the biotech campus Martinsried near Munich. IMGM is accredited according to DIN EN 17025, 15189 and operates a service center (Gene Expression Center, Martinsried) equipped with the most advanced technology platforms to support academic, clinical and industrial research with a broad range of services in the field of genomics, transcriptomics and biomedical applications. For more information, visit www.imgm.de.

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

Source: Business Wire

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