SYN-ONE TEST®

A NEW MILESTONE IN DIAGNOSING PARKINSON’S DISEASE AND RELATED DISORDERS

The Syn-One Test is the first commercially available test of its kind, applying world-class science and proven laboratory techniques to detect and visualize abnormal alpha-synuclein in cutaneous nerves. Delivers greater than 95% sensitivity and specificity as reported in multiple studies.

A New Diagnostic Paradigm

The Syn-One Test is a skin biopsy test that provides accurate pathological evidence to aid in the diagnostic evaluation of patients with clinical features suggestive of a synucleinopathy like Parkinson’s disease and related disorders. Syn-One is supported by technology licensed from Beth Israel Deaconess Medical Center in Boston (a Harvard Medical School affiliate.)

The synucleinopathies encompass a group of neurodegenerative diseases that include:

Parkinson’s disease
Dementia with Lewy bodies
Multiple system atrophy
Pure autonomic failure
REM sleep behavior disorder*

A test that identifies phosphorylated alpha-synuclein in cutaneous nerve fibers is highly specific for a diagnosis of a synucleinopathy but does not currently distinguish between synucleinopathies. Physicians should use the results of the Syn-One Test in combination with other clinical features to help make a more specific diagnosis.

*REM sleep behavior disorder (RBD) is considered a prodromal synucleinopathy. Sensitivity and specificity data on the Syn-One Test for RBD has not been established. Ongoing research is being conducted in patients with RBD.

1.REM sleep behavior disorder (RBD) is considered a prodromal synucleinopathy. Sensitivity and specificity data on the Syn-One Test for RBD has not been established. Ongoing research is being conducted in patients with RBD.

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
Diagnosing a neurodegenerative disease like Parkinson’s disease, dementia with Lewy bodies, or multiple system atrophy can be challenging.

While many patients present with unmistakable clinical features in advanced disease, the literature suggests that a misdiagnosis can occur 30-50% of the time in earlier stages of a synucleinopathy. This can lead to sub-optimal care recommendations and poor outcomes. As more effective, targeted drug therapies evolve, it will be critical for diagnostic tools to be put into practice as part of more personalized solutions.

How can you identify appropriate use cases for the Syn-One Test that would help increase diagnostic clarity?

The Syn-One Wheel diagram illustrates that there is an array of clinical presentations suggestive of different neurological disorders that can be clarified by using the Syn-One Test to detect the presence of phosphorylated synuclein in cutaneous nerve fibers.

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

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