A MILESTONE IN DIAGNOSING PARKINSON’S DISEASE AND RELATED DISORDERS
The Syn-One Test is supported by published research and established laboratory techniques to detect and visualize phosphorylated alpha-synuclein in cutaneous nerves, providing clinicians objective evidence to support informed clinical decision-making.
Advancing Diagnostic Precision
The National Institutes of Health (NIH) recognized the Syn-One Test as one of its “Top Promising Medical Findings for 2024”. The skin biopsy test provides pathological evidence to aid in the diagnostic evaluation of patients with clinical features suggestive of a synucleinopathy, including Parkinson’s disease, dementia with Lewy bodies, and related disorders. The technology supporting the test is licensed from Beth Israel Deaconess Medical Center in Boston, a Harvard Medical School affiliate.
The synucleinopathies are a group of neurodegenerative diseases that include:
- Parkinson’s disease
- Dementia with Lewy bodies
- Multiple system atrophy
- Pure autonomic failure
- REM sleep behavior disorder
Detection of phosphorylated alpha-synuclein in cutaneous nerve fibers is highly specific for a synucleinopathy but does not currently distinguish among individual disorders. Results should be interpreted in conjunction with other clinical findings to support a more specific diagnosis.
The Syn-One Test is a Laboratory Developed Test (LDT) performed in a CLIA-certified laboratory. It is not FDA-cleared or approved.
2.Clinicians may choose to exclude Congo red assay for assessment of amyloidosis
3.Although the skin biopsy sites for Syn-One do not target suspected skin abnormalities; CND pathologists report on benign and malignant findings. Patients with Parkinson’s disease and related disorders have a much higher risk of skin disorders than the general population (Skorvanek M, Bhatia KP. The skin and Parkinson’s disease: review of clinical, diagnostic, and therapeutic issues.Mov Disord Clin Pract vol. 4,1 21-31. 8 Sep. 2016, doi:10.1002/mdc3.12425)
Syn-One Test Advantages
>95% sensitivity and specificity*
In-office, minimally invasive procedure
Provides visual proof of p-syn
Provides increased diagnostic confidence and clarity
Convenient, evidence-based diagnostic tool
Supported by over a decade of published science
Proven Accuracy
Highly Specific, Highly Sensitive
The Syn-One Test has demonstrated >95% sensitivity and specificity* based on results from an NIH-supported, prospective, multicenter, blinded study of 428 patients along with other published studies in the last five years.
The range of sensitivity was 93-100% across the synucleinopathy subtypes (ie, Parkinson’s disease, multiple system atrophy, dementia with Lewy bodies, and pure autonomic failure).
This high level of accuracy provides physicians and patients with a new tool to help increase the clarity and confidence of a diagnosis and ultimately guide the recommended treatment plan.
*Gibbons CH, Levine T, Adler C, et al. Skin Biopsy Detection of Phosphorylated α-Synuclein in Patients With Synucleinopathies. JAMA. 2024;331(15):1298–1306. doi:10.1001/jama.2024.0792
Reimbursement
CND Life Sciences is a Medicare and Tricare participating provider and is working to establish in-network contracts with commercial payers given our strong and increasing body of scientific and clinical utility evidence. Since health benefits vary with different programs and plans, CND’s Patient Access team can help determine the expected benefits coverage for your patients before you conduct the required skin biopsies for the Syn-One Test. CND also offers self-pay options and payment plans for your uninsured and underinsured patients as needed.
Clinical Use Cases
Diagnostic Insights That Matter
Accurately diagnosing neurodegenerative diseases can be challenging, especially when presentations are atypical or do not meet clinical consensus criteria. The Syn-One Test provides clinicians with pathological evidence of phosphorylated alpha-synuclein in dermal nerve fibers, offering objective evidence of a synucleinopathy to inform the diagnostic evaluation.
While some patients present with clear clinical features in advanced disease, published literature suggests that diagnostic accuracy can be limited in earlier stages of synucleinopathies, with misdiagnosis reported in 30%-50% of cases. As targeted therapies continue to evolve, objective biomarkers will play an increasingly important role in supporting more personalized clinical decision-making.
Syn-One Test Pathology Report
The Syn-One Test Pathology Report includes a comprehensive, detailed examination of the patient’s pathologic results.
The report includes:
- The patient’s and provider’s information
- Summary of diagnostic conclusions
- Macroscopic review of the specimen and the stains performed
- Microscopic review of the specimen results
- Review of the patient’s unique pathology with patient-specific photographs and individual biopsy results
In addition to performing staining and analysis for phosphorylated synuclein, the Syn-One Test also includes results for small fiber neuropathy and amyloidosis.
Most Syn-One Test results are returned in 21 days; however this timeline may vary. If you have questions please contact your Clinical Account Manager at support@cndlifesciences.com
For Clinicians: Request a Skin Biopsy Test Kit
Our suite of neurodiagnostic tests provides clinicians with objective pathological insights on diseases that are often difficult to diagnose. Using our Skin Biopsy Test Kit, collect three small skin biopsies from your patient, send them to our CLIA-certified and CAP-accredited lab, and CND will provide important pathological insights to support a diagnosis.
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