Syn-One Test
Use
The Syn-One Test is designed to detect and visualize phosphorylated alpha-synuclein in cutaneous nerves, aiding in the diagnosis of synucleinopathies such as Parkinson's disease, dementia with Lewy bodies, multiple system atrophy, and pure autonomic failure. It provides clinicians with high sensitivity and specificity for the presence of these disorders and serves as an objective pathological confirmation, which can enhance diagnostic confidence and assist in guiding treatment plans. Particularly useful in cases where clinical diagnosis is challenging or atypical presentations occur, the test helps mitigate the risk of misdiagnosis that often happens in early stages of these neurodegenerative diseases.
Special Instructions
Not provided.
Limitations
The test is highly specific for synucleinopathies but does not distinguish between individual synucleinopathy types. It is not FDA-cleared or approved, and sensitivity or specificity for REM sleep behavior disorder has not been established. While the Syn-One Test offers high sensitivity and specificity (>95% for synucleinopathies), ongoing research is necessary to expand its utility, particularly in situations like REM sleep behavior disorder which is considered a prodromal synucleinopathy.
Methodology
Immunoassay (IHC)
Biomarkers
Phosphorylated alpha-synuclein
Protein
Result Turnaround Time
21 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Collect three small skin biopsies using the CND Life Sciences Skin Biopsy Test Kit.
