Proteome Sciences, in collaboration with the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health and Merck Millipore, announce the completion of the large, 1,000 sample Alzheimer’s Disease (AD) biomarker validation study. Preliminary results indicate that these biomarkers have significant potential diagnostic and prognostic utility that could form the basis of a series of simple blood tests for the diagnosis and management of this debilitating disease.
Three biomarker panels in blood, each containing between 11 and 16 proteins, have been identified which can discriminate between mild cognitive impairment (a syndrome often preceding AD), AD and control groups respectively. Proteome Sciences is filing further intellectual property around these panels which include and combine markers covered by existing patents with additional newly validated biomarkers.
It is currently estimated that 60% of people with AD have not been properly diagnosed and therefore are not being given vital drugs and care. The capability to distinguish between the levels and progression of the disease will enable drug developers to substantially improve patient care and people with mild cognitive impairment are likely to benefit the most from such disease-modifying drugs.
Currently AD biomarker and diagnostic development involves either cerebrospinal fluid (CSF) measurements, which requires invasive lumbar punctures or brain imaging via magnetic resonance imaging. Neither of these approaches are well-suited for use outside clinical trials. In contrast, commercialisation of a diagnostic based on plasma biomarkers would provide a screening approach for the disease.
Presenting the data at RASAD 2012 (Research & Standardisation in Alzheimer's Disease Conference) in Melbourne, Australia, Professor Simon Lovestone, Director of the NIHR BRC for Mental Health and Director of Research King’s Health Partners Academic Health Sciences Centre, London, commented:
“These results represent the largest study of plasma biomarkers to date, that we are aware of, and confirm our earlier findings that there are valuable diagnostic and prognostic signals in plasma. As new treatments for Alzheimer's disease are being developed, there is an increasing need for accurate and accessible markers of disease severity and progression. We will move quickly to support the development of clinical tests based on these biomarker panels.”
Dr. Simon Ridley, Head of Research from Alzheimer’s Research UK commented:
“There is an acute need for reliable diagnostic tools for Alzheimer’s disease, and this research on blood biomarkers is making good progress. These diagnostic tests have a way to go, but we look forward to seeing the approach develop towards clinical tests to harness these biomarkers.”
Dr. Linda Meeh, Director of Marketing for Immunoassays and Multiplexing, from Merck Millipore noted:
“There is a need for assay tools that enable greater insight into the biochemical changes in key proteins in neurodegenerative disease research. The panels of biomarkers are part of the MILLIPLEX® MAP portfolio, based on Luminex® xMAP® technology. These assays provide a high-throughput, multiplexed method that is more specific and sensitive than traditional single analyte methods, and provide the advantage of generating more data with less sample.”
Christopher Pearce, CEO of Proteome Sciences, said:
“This study is a major step towards a series of simple blood tests that would facilitate the early diagnosis and management of Alzheimer’s. Such tests will address a major unmet need and will have widespread application and commercial value. Our analysis of the data from this large study provides individual markers and defined marker panels that have good diagnostic and prognostic utility. Given the complexity of the data, we expect that the full analysis will introduce further biomarkers to the three panels announced today over the coming months and we are hopeful that collectively these will benefit patients and families suffering from the devastating effects of Alzheimer’s.”