Findings from retrospective chart review of patients with suspected Parkinson’s disease and related disorders show the use of skin biopsy for detection of abnormal synuclein in cutaneous nerves yielded changes in clinical diagnosis or treatment in over 75% of cases
SCOTTSDALE, Ariz., Dec. 18, 2024 /PRNewswire/ — CND Life Sciences (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today announced the publication of a study in the Movement Disorders section of Frontiers in Neurology on December 18, 2024, demonstrating the clinical utility of skin biopsy testing in the diagnosis and evaluation of synucleinopathies. These diseases, which include Parkinson’s disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA), are often difficult to diagnose accurately leading to delays or errors in medical management.
“For too long, neurologists have needed a simple, accurate test to help diagnose Parkinson’s disease, dementia with Lewy bodies and other related disorders,” said Todd Levine, MD, Chief Medical Officer of CND Life Sciences. “This study shows that by examining nerves in the skin, the Syn-One Test® fulfills that need, and contributes to clinical practice and decision making. Importantly, it builds on evidence from our previous study, which validated the accuracy of the Syn-One Test and its use as an essential diagnostic tool for physicians and their patients.”
In the current study, researchers performed a retrospective chart review of 97 patients who underwent skin biopsy for the Syn-One Test to detect the abnormal form of synuclein in the evaluation of neurodegenerative disease. Based on Syn-One Test results, 78% of patients had a change in their clinical care with 66% having a change in their diagnosis and 55% having a change in their treatment, regardless if the biopsy result was positive or negative. Changes in diagnosis were most common in patients with parkinsonism and prominent action tremor (93%), patients with postural instability and gait difficulties (90%), and patients with parkinsonism and prominent cognitive dysfunction (76%).
“The impact of these diseases can be life changing, and patients often experience long diagnostic journeys without a clear path forward,” said Jonathan Ross Isaacson, MD, who led the study at the Center of Autonomic and Peripheral Nerve Disorders at Beth Israel Deaconess Medical Center (BIDMC). “Our study suggests that the Syn-One Test has the potential to clarify diagnoses of these diseases and facilitate referrals to non-neurological medical specialties and rehabilitation disciplines such as neurosurgery, orthopedic surgery, physical, occupational and speech therapy.”
Due to a shortage of physicians with sub-specialties in movement, cognitive, and autonomic disorders, most patients facing a diagnosis of neurodegenerative diseases like Parkinson’s are not treated by neurological specialists, as underscored in a recent study of Medicare records. Because the Syn-One Test requires a small punch skin biopsy that can be collected from a patient in an office setting, the clinical utility can be enhanced by offering more geographically convenient access for patients earlier in the disease process.
“In this manuscript, we show how cutaneous detection of alpha-synuclein with a simple skin biopsy, when used in our tertiary care, academic medical center, informs clinical decision making and improves patient care,” noted Roy Freeman, MD, Professor of Neurology, Director of the Center for Autonomic and Peripheral Nerve Disorders at BIDMC, and one of the authors of the study. “This important evidence supports how this test can become a useful diagnostic tool in community settings to evaluate patients with signs and symptoms of these challenging diseases and triage them to more specialized care when needed.”
Full study: Clinical Utility of Synuclein Skin Biopsy in the Diagnosis and Evaluation of Synucleinopathies
About CND Life Sciences
CND Life Sciences supports the care of patients facing the potential diagnosis of neurodegenerative disease and other neurological conditions. Operating a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, CND developed the Syn-One Test to help clinicians diagnose Parkinson’s disease, dementia with Lewy bodies, and related disorders known as synucleinopathies. Syn-One uses proprietary immunofluorescence techniques to detect, visualize, and quantify phosphorylated alpha-synuclein in cutaneous nerves. Results of a recent prospective, multicenter NIH-sponsored study of the Syn-One Test were published in the Journal of the American Medical Association (JAMA) demonstrating >95% sensitivity in patients with a clinically determined synucleinopathy.1 The test analyzes three small skin biopsy samples collected in a clinician’s office through an in-office patient procedure and includes an assessment of intraepidermal nerve fiber density and other important pathologic markers. Approximately 2,000 neurologists and other clinicians in 49 states have used the Syn-One Test to support their diagnostic evaluation of patients. The Company also collaborates with biopharmaceutical companies on clinical trials for investigational therapies targeting neurodegenerative diseases and is conducting studies assessing the test’s ability to provide early disease detection and prognostic insights. For more information, visit cndlifesciences.com or connect with us on LinkedIn.
Dr. Freeman is a paid consultant, scientific advisor and board observer for CND Life Sciences and holds equity in the company. BIDMC also has an interest in CND Life Sciences as part of a licensing agreement and sponsored research.
1Gibbons 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.
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