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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.
“Lewy-related pathology (LRP), primarily comprised of αSyn, is present in a majority of autopsied AD brains, and higher levels of αSyn in the cerebrospinal fluid (CSF) of patients with mild cognitive impairment (MCI) and AD have been linked to cognitive decline.” (Ref.4)
There is a cost of not knowing when diagnosing a disease. Identifying the dementia subtype can allow for more effective management and prognostic insights.
"Earlier identification of dementia and its subtypes, followed by pro- active care aimed at the prevention and management of expensive co-occurring conditions, has the potential to mitigate the high costs of dementia." (Ref.9)
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.
"Our findings suggest that non-Alzheimer's disease pathological diagnoses play an important role in the clinical phenotype of early-onset Alzheimer's disease with potentially significant implications for clinical practice and clinical trials design." (Ref.5)
SYNTap Test has demonstrated through internal studies to detect > 94% of AD/DLB 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.
A pioneer in the science of detecting mis-folded proteins, Amprion advances the diagnosis of brain disorders. Our SYNTap™️ Biomarker Test aids physicians in diagnosing Parkinson’s, Lewy Body Dementia, and Alzheimer’s with Lewy Body variant. We plan to launch more biomarker tests in the future.
To improve patient access to the SYNTap® Biomarker CSF Test, Amprion offers the following billing options:
Please note: Amprion is a Medicare participating provider, however, the SYNTap test does not currently have Medicare coverage determination. Also, Amprion is not yet in network with most insurers.
The SYNTap Biomarker CSF Test has been issued a dedicated CPT® PLA code to be used when billing: 0393U.
For additional information, please visit our billing page.
