-Data from the NIH-sponsored Synuclein-One Study shows the Syn-One Test® detected phosphorylated alpha-synuclein in skin biopsies of >95% of synucleinopathy patients
-The prospective, multicenter, blinded study involved 428 participants across 30 U.S. sites with expert investigators covering movement disorders, dementia, and dysautonomia

April 26, 2023 – Scottsdale, Ariz. – CND Life Sciences, a medical technology company pioneering the development of cutaneous neurodiagnostics, today announced topline results from its landmark Synuclein-One Study sponsored by the National Institutes of Health (NIH). This prospective, multicenter study demonstrated that the company’s Syn-One Test® detected the pathological form of alpha-synuclein in the skin of over 95% of patients diagnosed with a synucleinopathy, a group of disorders that includes Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, and pure autonomic failure.

These results were presented in a platform session at the 75th American Academy of Neurology (AAN) Annual Meeting in Boston and represent a major advancement in the development of more objective, precise, and convenient diagnostic tests for neurodegenerative diseases.

“No study has ever demonstrated higher sensitivity and specificity across the synucleinopathies, including those using spinal fluid,” said Todd Levine, MD, Chief Medical Officer of CND Life Sciences and the principal investigator of the study. “These results validate cutaneous alpha-synuclein as a reliable biomarker for Parkinson’s disease and related disorders, allowing us to offer the Syn-One Test as an accessible, patient-friendly diagnostic solution for clinical practice and an important technology for biopharmaceutical trials targeting alpha-synuclein.”

Overall, the 428-participant Synuclein-One Study demonstrated the following performance characteristics of the Syn-One Test:

• Sensitivity was 95.5% in detecting phosphorylated alpha-synuclein across all patients with a clinically-diagnosed synucleinopathy.
• Sensitivity ranged from 92.7% for patients diagnosed with Parkinson’s disease to 100.0% for those with pure autonomic failure.
• Specificity was 96.7% derived from 120 healthy volunteers.
• Minimal, non-serious adverse events were reported in only 0.4% of participants.

“Having access to a reliable clinical tool to diagnose the diseases collectively defined as ‘synucleinopathies’ is an urgent unmet need to help optimize treatment pathways for patients,” said Joseph Jankovic, MD, Professor of Neurology and Distinguished Chair in Movement Disorders, Baylor College of Medicine, Houston, Texas. “With a minimally invasive skin-based test like Syn-One, we can offer our patients a higher degree of confidence and accuracy in the diagnosis of Parkinson’s disease, dementia with Lewy bodies, and multiple system atrophy, and differentiate these disorders from other neurodegenerative diseases. This will change how many of these patients are evaluated and treated.”

Neurodegenerative disorders like Parkinson’s disease are misdiagnosed over 30% of the time particularly early in the disease course.[i],[ii] Diagnostic uncertainty can lead to delays in patient care and introduces the possibility of unnecessary tests, procedures, and medications along with increased anxiety for the patient and family. Having a convenient, evidence-based tool that improves the effectiveness of diagnosing neurodegenerative diseases is a major step forward for clinical care and will be vitally important when disease-modifying therapies become available.

“We are grateful for the commitment of over 400 participants and 30 investigator teams in the Synuclein-One Study,” said Christopher Gibbons, MD, Senior Scientific Advisor to CND Life Sciences and the study’s lead author. “The results confirm a decade of research demonstrating that nerves in the skin serve as a unique window into the central nervous system and support the thesis that distinct synuclein deposition signatures and other cutaneous markers can differentiate among the synucleinopathies,” added Gibbons. “These findings provide immediate benefit to patient care and will help advance novel drug development for neurodegenerative diseases.”

About the Synuclein-One Study
The Synuclein-One Study is an NIH-funded investigation to determine the accuracy, sensitivity, specificity, and precision of skin biopsy detection of phosphorylated alpha-synuclein in patients clinically diagnosed with a synucleinopathy.

This prospective, multicenter, blinded study evaluated phosphorylated alpha-synuclein pathology in cutaneous tissues in individuals with Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, and pure autonomic failure. From February 2021 to December 2022, the study enrolled 428 participants across 30 sites, including expert clinician-researchers specializing in movement disorders, dementia, and dysautonomia. In addition to the careful enrollment screening protocol and diagnostic determination by each investigator, an expert panel reviewed and adjudicated the clinical diagnoses for all enrolled individuals. This protocol design offered the closest parallel to the gold standard diagnostic evaluation, which remains pathological review at autopsy.

About the Syn-One Test
The Syn-One Test is an anatomic pathology assay used by neurologists and other clinicians to help diagnose patients who present with clinical features suggestive of a synucleinopathy, with the most prevalent of these conditions being Parkinson’s disease. The test analyzes three small skin biopsies collected from the patient in a physician’s office through a 15-minute minimally invasive procedure and includes an assessment of intraepidermal nerve fiber density and other important pathologic evaluations in the skin. Applying proprietary immunofluorescence methods, CND provides the clinician with a pathology report that includes microscopic images of a patient’s skin biopsy, noting if phosphorylated alpha-synuclein is detected inside dermal nerves. Nearly 700 neurologists in over 40 states have ordered almost 10,000 Syn-One Tests in clinical practice since late 2019. The Syn-One Test is supported by technology licensed from Beth Israel Deaconess Medical Center in Boston and leverages a decade of published science from leading academic institutions in multiple countries.

About CND Life Sciences
CND Life Sciences is dedicated to supporting the care of patients facing the potential diagnosis of a neurodegenerative disease and other neurological conditions. Operating a CLIA-certified laboratory in Scottsdale, Arizona, CND launched the Syn-One Test in 2019 as the world’s first commercially available test to detect, visualize, and quantify phosphorylated alpha-synuclein located in cutaneous nerves. The company has research collaborations with multiple biopharmaceutical companies and has been awarded three prestigious NIH SBIR grants to advance the validation and clinical utility of its Syn-One Test. CND was also recently awarded an American Rescue Plan Act (ARPA) grant from the State of Arizona to study cutaneous biosignatures in patients suffering from long COVID using digital technology and artificial intelligence. For more information visit www.cndlifesciences.com.

Disclosure: Research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke and the National Institute on Aging (NIA) of the National Institutes of Health under Award Numbers R44NS117214, R44AG076072, and R44NS127696. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Contact:
JPA Health
Mary Parra
P: 928-853-4733
mparra@jpa.com

SOURCE: CND Life Sciences
[1] Adler CH, Beach TG, et al. “Low clinical diagnostic accuracy of early vs advanced Parkinson disease: clinicopathologic study.” Neurology. 2014 Jul 29;83(5):406-12.
[1] Koga et al. “When DLB, PD, and PSP masquerade as MSA an autopsy study of 134 patients.” Neurology. 2015 Aug; 85:404.

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