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What is the Syn-One Test®?

By September 15, 2023October 2nd, 2023No Comments

What is the Syn-One Test®?

The Syn-One Test is the first commercially available test of its kind, helping clinicians diagnose a synucleinopathy through the analysis of a small skin biopsy collected from the patient in an office setting.

Synucleinopathies are a family of neurodegenerative disorders that carry a common pathological feature – the presence of phosphorylated alpha-synuclein that can be detected in dermal nerves of patients who exhibit a range of distinct clinical signs and symptoms. Synucleinopathies include Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, pure autonomic failure, and REM sleep behavior disorder. These conditions are challenging to diagnose definitively, particularly earlier in the disease process. The scientific literature suggests that even in the hands of specialists, the misdiagnosis rate is estimated to be over 30%. The Syn-One Test, which is supported by technology licensed from Beth Israel Deaconess Medical Center in Boston (a Harvard Medical affiliate) has been used by nearly 1,000 neurologists and other clinicians to help in the care of over 10,000 patients across the US in the last four years. The science of the Syn-One Test has been published by leading researchers around the world for a decade and continues to be studied through grants from the National Institutes of Health (NIH) and other leading organizations.

What can the Syn-One Test tell me?

The Syn-One Test helps provide an objective pathological picture underlying the neurological condition of a patient who presents with signs and symptoms of a potential neurodegenerative disorder like Parkinson’s disease. Syn-One gives a clinician unique insights of what may be happening in a patient’s central nervous system by examining important markers of disease that can be found in nerves of the skin. Syn-One uses immunofluorescence techniques to detect, visualize and quantify the deposition of abnormal, phosphorylated alpha-synuclein within dermal nerves and simultaneously measures the density of intradepidermal nerve fibers to detect evidence of neurodegeneration as seen in some neurodegenerative diseases and in peripheral neuropathies. Syn-One includes modified Congo Red staining to identify amyloid proteins to support a diagnosis of amyloidosis and applies hematoxylin and eosin for overall skin morphology. A clinician receives a pathology report typically within 2-3 weeks of performing the Syn-One skin biopsy describing results of CND’s analysis of each of the above components (from all three recommended three biopsy sites).

What makes the Syn-One Test different?

Syn-One is the only commercially available test that uses skin biopsies taken in your office to provide visual proof of a synucleinopathy. The procedure is simple, convenient, minimally invasive, and has been shown to detect phosphorylated alpha-synuclein even in early stages of disease. Test kits are free, shelf-stable for one year, and the collected biopsies are shipped at room temperature to our CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona. The Syn-One Test is also less expensive, more convenient, and more specific than the DaTscan.

Is the Syn-One Test covered by insurance?

CND Life Sciences is a Medicare and Tricare participating provider and is working diligently 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.

How accurate is the Syn-One Test?

The Syn-One Test has demonstrated the highest accuracy performance (96%) of any alpha-synuclein biomarker test to date, most recently generating >95% sensitivity and specificity in an NIH-supported, prospective, multicenter, blinded study of 428 patients.* 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).

Why should my practice offer the Syn-One Test?

Arriving at and delivering a diagnosis of a neurodegenerative disease is often not easy or straightforward. By detecting and visualizing pathological evidence of a synucleinopathy, the Syn-One Test can help provide greater confidence and clarity to support an accurate diagnosis for your patients.

Learn more and order free test kits

*Gibbons CH, Levine T, Bellaire B, et al. The Synuclein-One Study: Skin biopsy detection of phosphorylated alpha-synuclein for diagnosis of synucleinopathies. Neurology. 2023;100(17 suppl 2). 2023 Annual Meeting Abstracts.