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Findings from DiaGenic, Pfizer R&D Collaboration Show Promising Early Results for Blood-based Test for Early Alzheimer Disease

Today reports preliminary positive findings from the collaborative R&D project with Pfizer Inc. where the objective is to identify blood-based biomarkers that may be useful in diagnosing and monitoring of Alzheimer’s Disease (AD). The study cohort consisted of a total of 120 subjects, including healthy elderly controls, patients with mild cognitive impairment (MCI) and patients with AD. Baseline and two-year longitudinal samples from DiaGenic’s clinical multicenter studies and biobank were used for the study.

“A blood-based test that will allow community doctors to diagnose or refer patients to specialists at the earliest stages of Alzheimer’s disease will be critical to attaining the ultimate goal of preventing the onset of clinical dementia signs and symptoms," says Sam Gandy, M.D., Ph.D., Professor of Neurology and Psychiatry and Director of Mount Sinai Alzheimer's Disease Research Center. Dr. Gandy is a scientific advisor to DiaGenic but he was not involved in the study.

“Such a test will also be essential to drug development by enabling the identification of high risk subjects at pre-clinical stages so that they can be enrolled in drug trials by pharmaceutical companies and academic laboratories as we seek to develop an effective disease-modifying therapy for Alzheimer’s disease. "If DiaGenic’s biomarkers are validated and subsequently approved by the applicable regulatory authorities, this test panel has the potential to speed trial recruitment, to reduce trial size and costs, and to form an important cornerstone of our successful approach to this emotionally and economically devastating illness,” he continues.

“Early identification of MCI patients who will go on to develop Alzheimer’s dementia has the potential to significantly reduce drug development costs”, said DiaGenic CEO Erik Christensen, M.D., Ph.D. “These findings demonstrate the strengths of DiaGenic’s technology and expertise within blood-based CNS biomarkers. DiaGenic’s strong IP portfolio linked to measuring gene expression in blood makes us unique,” Dr Christensen adds.

The study results will be presented at 4th Conference Clinical Trial on Alzheimer's Disease, 3th-5th November - San Diego, CA, USA.

About&MCI&and&prodromal&AD

Alzheimer's disease (AD), the most common form of dementia, is a fatal, degenerative brain disease that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities.

Mild cognitive impairment (MCI) is a transitional stage between normal aging and dementia. It involves problems with memory, language, thinking and judgment that are greater than typical age-related changes. Mild cognitive impairment increases your risk of later developing dementia, including Alzheimer's disease and studies show that 50% of patients with MCI will over time convert to having Alzheimer’s dementia. No easily accessible diagnostic tools for identifying these MCI patients exist today.

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 of the body. DiaGenic has developed and CE marked two blood based diagnostic tests, BCtect® for early breast cancer detection and ADtect® for early detection of Alzheimer’s Disease. The company protects its technology through an extensive patent portfolio. DiaGenic promotes its products towards leading pharmaceutical and imaging companies, and towards clinicians. DiaGenic is listed on the Oslo Stock Exchange. For more information visit www.diagenic.com

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