Skin test can detect alpha-synuclein clumps, aiding Parkinson’s diagnosis

The words "Clinical Trials" are framed by tablets of medicine and a heart meter.

A test that uses skin biopsies was able to detect the form of alpha-synuclein protein that causes toxic clumps in the brain of people with Parkinson’s disease and similar conditions in more than 90% of the patients enrolled in a National Institutes of Health (NIH)-sponsored clinical trial.

“We believe this is a crucial decade of innovation for the neurodegeneration field, one that will result in major progress in precision diagnostics, new treatments, and more promising futures for patients and families,” said Roy Freeman, MD, senior scientific advisor and co-founder of CND Life Sciences, the developer of the Syn-One Test, in a company press release.

“The publication of this important NIH-sponsored study is one big step forward with many more milestones to come,” said Freeman, the lead author of “Skin Biopsy Detection of Phosphorylated α-Synuclein in Patients With Synucleinopathies,” which was published in the Journal of the American Medical Association.

The aggregation of alpha-synuclein into clumps called Lewy bodies is a hallmark feature of Parkinson’s disease as well as some forms of atypical parkinsonism, including Lewy body dementia (LBD), multiple system atrophy (MSA), and pure autonomic failure (PAF). Collectively, these disorders are referred to as synucleinopathies. The toxic aggregates are composed of phosphorylated alpha-synuclein, a modified form of the protein that has the tendency to clump and form insoluble aggregates that lead to nerve cell death.

While early diagnosis is paramount for patients to access neurological care, evidence suggests Parkinson’s and other synucleinopathies are misdiagnosed, particularly at the early disease stages, in more than 30% of the cases. Plus, most tests in the diagnosis are highly invasive, such as a spinal tap, which is used to collect cerebrospinal fluid (CSF), which surrounds the brain and spinal cord.

“Detecting phosphorylated alpha-synuclein through cutaneous nerves is a more convenient pathway than other tests requiring spinal fluid or nuclear medicine imaging,” said Todd Levine, MD, chief medical officer of CND Life Sciences and a study author.

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How does Syn-One work?

In the Syn-One Test, biopsies of a patient’s skin are collected from the neck, thigh, and calf. The samples are then analyzed to see if phosphorylated alpha-synuclein is detectable in skin nerve fibers.

Funded by the NIH, the main goal of the Synuclein-One Study (NCT04700722) was to assess the test’s ability to detect phosphorylated alpha-synuclein. The main analysis included 96 people with Parkinson’s, 127 people with other types of synucleinopathies (55 with MSA, 50 with LBD, and 22 with PFA), and 120 people with no known neurological disease, who served as controls.

The results revealed a Syn-One Test was positive in 92.7% of Parkinson’s patients, 98.2% of MSA patients, 96% of LBD, and 100% of PAF patients. A negative test was reported in 96.7% of the controls.

“This study validates the role of skin biopsy detection of phosphorylated alpha-synuclein as an important diagnostic tool for physicians and patients,” said Christopher Gibbons, MD, a senior scientific advisor and co-founder of CND Life Sciences and the study’s first author. “Accessibility to accurate testing modalities that pinpoint the pathology of these diseases has been a real challenge for both clinical practice and clinical trials, so we are quite pleased to see the strong positivity and specificity results of using skin as a reliable diagnostic method.”

Both the CND scientists and their academic partners continue working to improve the Syn-One Test. According to the company, exploratory programs and clinical studies are underway to assess its performance in early disease diagnosis, correlation with neurological biomarkers, and signatures of specific disease subtypes.

“The Syn-One Test has been ordered by over 1,200 neurologists in 46 states to aid the diagnosis of 20,000 patients in the last few years. By providing objective, visual proof of the known pathological marker of Parkinson’s disease, dementia with Lewy bodies, and other synuclein disorders, the Syn-One Test is truly helping clinicians increase diagnostic confidence and provide better care to patients,” Levine said.

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