Unique Diagnostic Test Based on Mass Spectrometry Technique Accurately Identifies Early-Stage Alzheimer's Disease

Cerebral amyloid load is one of the first signs of early-onset Alzheimer's Disease (AD) in individuals with subjective memory complaints (SMCs) and has potential for use as a biomarker to indicate how the condition evolves. A new assay based on mass spectrometry has shown to be capable of quantifying amyloid-beta 40 and 42 proteins – both associated with the risk of having AD – in plasma samples.

Araclon Biotech (Zaragoza, Spain), a Grifols Group company, has developed ABtest-MS, a novel and unique method based on the mass spectrometry technique, that is capable of accurately quantifying amyloid 40 and 42 proteins in plasma samples. Diverse studies have confirmed the high predictive ability of the ABtest-MS assay to identify precisely those subjects with cerebral amyloid load, which would enable management of AD in its initial phases. ABtest-MS is a differentiating method that does not contain antibodies and whose process avoids enzymatic digestion, saving time and expense.

Data from the trial conducted on the FACEHBI cohort, obtained after two years of follow up, confirm the potential of the ABtest-MS to predict cerebral amyloid load in individuals with SMCs and the potential that the analysis of these markers have as an indicator of how the condition evolves. The data corresponding to five years of follow up with the cohort are currently being analyzed. In the second study, the multicenter A4 Study carried out in 50 centers, the ABtest-MS predicted the cerebral deposit of the amyloid protein (measured by PET) in plasma samples from 731 subjects. It also confirmed the suitability of utilizing a centralized and extensively validated method such as this assay in these broad and heterogenous studies. These data confirm other results previously obtained on more than 1,000 subjects in different AD stages from various international cohorts that have been recently featured in scientific publications.

"This test's predictive ability makes it ideal to detect early-stage Alzheimer's and accelerate the recruitment for clinical trials of new treatments, reducing the screening failure rate and associated costs," said Jose Terencio, Araclon CEO and Vice President of Innovation at Grifols.

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