This biomarker test can detect α-Synuclein with 87% sensitivity, 97% specificity, and 93.9% accuracy.
Underlying Synuclein pathology has been associated with a more rapid progression of disease and declines in cognitive function.
There is a cost of not knowing when diagnosing a disease. Identifying the Dementia subtype can allow for more effective management and prognostic insights.
Understanding the heterogeneity of Alzheimer’s is key to develop novel disease-modifying therapeutics and calls for additional biomarker testing. AD is no longer just A-T-N.
Therefore, identifying multiple pathologies in AD is important to treatment decisions and clinical trial recruitment.
SYNTap Test has demonstrated through internal studies to detect > 94% of AD-LBV CSF samples confirmed at autopsy.
In a joint study with the Oregon Health & Science University (OHSU), Amprion conducted blinded analysis using CSF samples; during clinical test development, the SYNTap Test accurately predicted the presence of Lewy bodies confirmed at later autopsy. CSF samples were collected 1-15 years before autopsy from patients clinically diagnosed with AD (n=43), some other non-synucleinopathy neurodegenerative disease (n=12), and healthy control subjects (n=4).
Notably, the SYNTap Test detected the presence of misfolded a-Synuclein in CSF from a clinically diagnosed AD patient 10 years before the autopsy identified the presence of Lewy Bodies.
Similar results were observed in a confirmatory research study performed with the University of California, San Diego (UCSD) using CSF collected prior to autopsy (n=64), as well as CSF collected postmortem (n=32). None of the CSF samples from 36 patients who had no brain Lewy bodies at autopsy tested positive. During our Clinical Validation, the SYNTap Test detected the presence of misfolded a-synuclein aggregates – the key component of Lewy Bodies, with a very high sensitivity of 87.3% and a specificity of 97.2%.
Download the SYNTap Test Specification Sheet for details.