AlzoSure Predict blood-based prognostic test for Alzheimer’s disease. Credit: Diadem / PRNewswire.

Diadem has announced the results of a clinical validation study that confirms its AlzoSure Predict prognostic blood test can accurately predict the progression to Alzheimer’s disease (AD).

The online edition of the Journal of Prevention of Alzheimer’ Disease published an article on the study.

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According to the authors of the study, AlzoSure Predict can predict whether an individual with or without minor cognitive impairments will advance to AD in the future.

The blood test can provide the prediction up to six years before conventional diagnosis.

Diadem CEO Paul Kinnon said: “This new peer-reviewed publication confirms that AlzoSure Predict uniquely has the ability to accurately identify individuals with no symptoms or only mild cognitive symptoms who will progress to full-blown AD up to six years prior to diagnosis.

“Importantly, the test requires only a simple blood draw and widely available laboratory instruments, making it suitable for broad-based public health screening applications.”

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A non-invasive biomarker blood test, the AlzoSure Predict test calculates the presence of an unfolded conformational variant of the p53 protein (U-p53AZ) in patient plasma.

Several studies have indicated that the presence of this protein is associated with AD.

The retrospective longitudinal prognostic study assessed plasma samples from 482 individuals in the age group of 60 and older. The subjects participated in the Australian Imaging, Biomarkers and Lifestyle (AIBL) cohort over a period of six years.

Recently, the test received CE-IVD marking. It has also received a Breakthrough Device designation from the US Food & Drug Administration (FDA).

In March, Diadem raised funds to commercialise and clinically validate the AlzoSure Predict test.