Alzheimer's Breakthrough: DiaGenic ASA Presents Award Winning Test Data at IPA in Stockholm; Pilot Study Paves Way for Blood-Based Test for Detection of Alzheimer's Disease.

STOCKHOLM, Sweden -- Norwegian life sciences company DiaGenic ASA (OSE:DIAG) today announced it was awarded first place for its poster presentation "Detection of Alzheimer's disease based on gene expression patterns in peripheral blood cells" at the International Psychogeriatric Association's (IPA) 12th Congress in Stockholm. The data DiaGenic ASA presented at IPA shows that its patented method to develop gene expression (Editor's notes 1 and 2) signatures using peripheral blood samples can be applied to detect Alzheimer's disease. This makes the development of a blood test for Alzheimer's disease a possibility for the first time.

"There is need for a simple, accurate and convenient method that can detect Alzheimer's disease at an early stage," said George T. Grossberg, President IPA. "Such a method will enable treatment at an early stage and would be particularly suitable for screening."

Working in collaboration with the Ulleval University Hospital in Oslo, DiaGenic ASA researchers identified a gene expression signature based on a panel of 33 genes that correctly predicted the diagnostic class in 34/37 samples. This work was performed on an in-house macroarray (Editor's note 3). However, since the method has previously been validated in the company's simultaneous breast cancer research project as working on commercial microarray, DiaGenic ASA has already initiated a wider study, expected to be completed in early 2006, using ABI microarray technology. The study aims to both validate the findings on in-house platform and identify additional gene candidates that will form the basis for the development of a diagnostic test for Alzheimer's disease.

"Currently no single test exists to confirm Alzheimer's disease in a living person, therefore diagnosis usually relies on subjective means, such as memory tests," said Anders Lonneborg, CEO, DiaGenic ASA. "Since early therapeutic intervention can make a significant difference in improving quality of life, an early, accurate and convenient diagnosis is a critical unmet medical need. Having validated our method on our in-house macroarray, we now expect to be able to move quickly to the development of a blood based test to diagnose Alzheimer's disease."

DiaGenic ASA received a U.S. patent in 2004 for using gene expression signatures from peripheral blood cells to diagnose Alzheimer's disease (US patent: 6,720,138).

Editor's notes

Explanation of terms

1) Gene expression is the process by which a gene's information is converted into the structures and functions of a cell. It is a complex process which starts with the transcription of each person's unique genetic code into a messenger (mRNA) that transfers the genetic information out to the machinery in the cell that generates its structure and function. There, it is translated into a protein directing various cellular functions.

2) Gene expression can be measured with DNA array technology. This is a device that gives a measure of the cellular concentration of different mRNAs. This measurement is known as expression profiling. A DNA array is simply a solid support such as a slide with specifically arranged DNA molecules on it.

3) Compared to microarray, macroarray is larger in size and has a lower capacity for analyzing gene expression.

Impact and social costs of Alzheimer's disease

Alzheimer's disease (AD) is the most costly disease for our societies. It is more costly than both cardiovascular disease and cancer put together (Ref. Dr Bengt Winblad; Alzheimer's Association International Conference on Prevention of Dementia, Washington June 20, 2005).

Alzheimer's disease is the most common cause of dementia in people above the age of 65, at this age 5-10% have the disease, while close to 40% of those 90+ are affected.

Demographic changes in the population of Western societies will result in a dramatic increase of the number of demented people. The worldwide population of people aged more than 65 years is expected to increase from 420 million (2000 figures) to approx. 973 million in year 2030.

--An estimated 28 million people suffer today from Alzheimer's related dementia of which approx. 4.5 million in the US

--An estimated 2,500,000 new cases arise every year of which approx. 300,000 in US and 750,000 in Europe

--By 2050 these figures will increase dramatically to approx. 100 million world wide, and close to 16 million in the US

--The total cost to society is estimated to be $156 billion world wide

--In the US, direct and indirect costs of caring for AD patients are at least $100 billion

--Medicare's costs for beneficiaries with AD are expected to increase from $91 billion in 2005 to $160 billion in 2010

--In 2005 National Institute of Aging will spend $647 million on AD related R&D

Diagnosing AD

There is no one single diagnostic test that can detect whether a person has AD. Instead a diagnosis comprises several elements - reviewing a detailed history on the person and the results from several tests, including a complete physical and neurological examination, and a psychiatric assessment and laboratory tests. This takes several days and requires considerable resources from many health care providers and still can at best only provide a diagnosis with 80-90% certainty.

--Determination of medical history. This also includes interviews with family members to gather background on the person's daily function, and current mental and physical conditions

--Physical examination will include checking blood pressure, pulse and nutritional status and a search for the presence of cardiac, respiratory, liver, kidney and thyroid diseases as some of these conditions may cause dementia

--Laboratory tests are used to rule out other disorders. They may include full blood count, testing for anemia, B12 and folate, diabetes and kidney function

--Brain imagining techniques are more and more frequently used. They may include CT (computerized tomography) scans and MRI (magnetic resonance imaging) searching for evidence of tumors, stroke and blood clots. New emerging techniques include PET (positron emission tomography) and SPECT (single proton emission computed tomography). They are currently far too expensive to be in routine clinical use

--Psychiatric and psychological evaluations can rule out the presence of other illnesses, such as depression causing some of the same symptoms as AD. Neuropsychiatric testing will normally involve a questionnaire to evaluate cognitive function. The most frequently used test is the Mini Mental State Examination (MMSE).

These pathological findings are becoming the targets for many of the new therapeutics that are now in clinical trials. None of these tests are confirmatory, but rather are used to rule out other conditions that could cause similar symptoms to AD. Currently, confirmation of AD is only possible with a post mortem biopsy.

The AD diagnostic market

Diagnosing AD requires many different types of neurological, psychiatric, mental and blood tests. Most of them are used to rule out other disorders with the same type of clinical symptoms. Together this becomes very expensive and time consuming. It is very difficult to estimate the total cost of diagnosing a single AD case, but it may well easily reach $5000/case when PET or other imaging technologies are used. An average figure may be $1000-3000 in the US and somewhat lower in Europe; $700-2000.

Based on the number of new cases diagnosed every year, a very realistic market estimate for the Western world would be:

--US with approx. 300,000 new cases, the AD diagnostic market, including all the different tests needed to establish a diagnosis, is minimum of $3-9 million/year

--In Europe with approx. 750,000 new cases, the AD diagnostic market would be $5-15 million/year

--With the increase of the elderly population these figures will show a steady and stable yearly increase.

Cost of some of the new emerging technologies:

--MRI costs $1200-1800

--A PET (positron emission tomography) may indicate AD at an early stage by measuring the reduction in brain metabolism of glucose. However, a scan costs $1500-3500 depending on type of scan which prohibits a widespread use. (PET is now reimbursed in the US)

--SPECT (single photon emission computed tomography) is used to examine localised blood flow in the brain and is cheaper than PET, $500-700, but may only provide information useful to rule out other disorders such as vascular dementia

--Cost of APOE genetic testing is approx. $150/test