The ATN framework establishes a means for classifying biomarkers based on the biological evidence of Alzheimer’s disease that each marker provides1. These markers are divided into three categories to reflect the three primary biological changes associated with Alzheimer’s:
|Beta-Amyloid 42/40 Ratio||Assess levels of pathologic change consistent with Alzheimer’s disease|
|Phosphorylated Tau 181 (pTau181)|
|Neurofilament Light Chain (NfL)||Assess disease severity by measuring neurodegeneration|
This is the first Alzheimer's blood test that combines three Alzheimer's biomarkers that is simple, non-invasive and gives objective evidence for the biological changes associated with Alzheimer's disease. The test is intended to be used by clinicians for patients that may be undergoing a dementia workup.
Biological confirmation of disease is necessary for diagnosis. This test provides evidence of the biological changes that are consistent with Alzheimer’s disease. However, Alzheimer’s still requires a clinical diagnosis based on clinical observation and cognitive testing.
The ATN Profile was clinically validated using 200 samples from a well-studied cohort in which all samples were characterized with patient age, sex, amyloid PET status, and clinical diagnosis. The beta-amyloid 42/40 ratio assay showed a ROC analysis area under the curve (AUC) of 0.944, with a sensitivity of 96% and specificity of 86.7%.
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