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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.

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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.

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Syn-One Test Advantages

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>95% sensitivity and specificity*
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In-office, minimally invasive procedure
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Provides visual proof of p-syn
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Provides increased diagnostic confidence and clarity
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Convenient, evidence-based diagnostic tool
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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 alpha-synuclein in patients with synucleinopathies. JAMA.  Published online March 20, 2024. 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

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. 

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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 free Skin Biopsy Test Kit, simply 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.

Order a Kit