Grant Supports the Continued Validation and Enhancement of the Syn-One Test™ To Help Physicians Diagnose Parkinson’s Disease and Other Serious Disorders
October 26, 2020 — Phoenix, AZ – Cutaneous NeuroDiagnostics (d/b/a CND Life Sciences), an innovative medical technology company pioneering the detection, visualization, and quantification of protein deposition in cutaneous nerve fibers, has been awarded a $2.4 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (NIH) . Todd Levine, MD, a neuromuscular neurologist and CND’s co-founder and Chief Medical Officer will serve as the Principal Investigator (PI) on the two-year grant.
“We are honored to receive this prestigious NIH grant,” said Dr. Levine. “The award will support the largest study of its kind to enhance the precision and clinical utility of our Syn-One Test, which is being adopted by neurologists to improve the diagnosis of neurodegenerative disorders, notably Parkinson’s disease.”
The NIH grant allows CND to conduct a 500-patient, multicenter clinical study with leading neurologists and academic centers across the U.S. The study aims to further validate the sensitivity and specificity of CND’s Syn-One Test to distinguish between the different types of synucleinopathies. This large-scale scientific assessment of CND’s diagnostic approach and pathological methods will provide physicians and patients with even greater evidence to support broad clinical adoption of the Syn-One Test.
“CND is determined to improve how physicians diagnose and treat patients with signs and symptoms of neurodegenerative diseases, especially early in the disease process,” said Richard Morello, Chief Executive Officer, CND Life Sciences. “Advancing a convenient, minimally invasive test that can offer physicians and patients a higher degree of confidence and accuracy in the diagnosis of difficult diseases like Parkinson’s and dementia with Lewy bodies will help the field take a big step forward.”
About the Syn-One Test
The Syn-One Test leverages a decade of published science by world experts and carefully honed laboratory techniques to identify an abnormal form of a protein known as alpha-synuclein. By obtaining three small punch skin biopsies performed in office by the patient’s clinician, CND applies specialized methods to detect folded, phosphorylated alpha-synuclein in dermal layers of the skin. This abnormal form is a well-known biomarker for a family of diseases called synucleinopathies, the most prominent type being Parkinson’s disease. A physician ordering Syn-One receives a detailed report of the pathologic findings of the test, including visual images of the patient’s cutaneous nerve fibers and a determination of the presence of abnormal synuclein.
There are over 20 million people in the US who suffer from movement disorders, cognitive impairment, autonomic dysfunction, and sleep disorders collectively. A percentage of these patients exhibit signs and symptoms indicative of a synucleinopathy, a group of serious neurodegenerative diseases including Parkinson’s and dementia with Lewy bodies, that universally feature abnormal alpha-synuclein. For a portion of these patients, the absence of objective pathological proof makes a physician’s diagnosis and treatment choices difficult to determine with confidence. Published studies suggest that even the most experienced neurologists specializing in movement disorders have challenges making positive diagnoses of Parkinson’s disease in 30% of cases early in the disease course.
About CND Life Sciences
Founded in 2017, CND Life Sciences is dedicated to supporting the care of patients suffering from neurodegenerative diseases and other related conditions. Operating a CLIA-certified laboratory in Phoenix, Arizona, CND launched the Syn-One Test™ as the world’s first commercially available test to detect, visualize, and quantify the presence of abnormal, phosphorylated alpha-synuclein in cutaneous nerve fibers. The test is intended to serve as an objective, evidence-based diagnostic tool to aid in the confirmation of synucleinopathy in patients with suspected Parkinson’s disease (PD), dementia with Lewy body (DLB), multiple system atrophy (MSA), pure autonomic failure (PAF) or REM sleep behavior disorder (RBD). Through proprietary staining and analysis of three (3) small punch skin biopsies performed and provided by a referring clinician, CND offers a convenient, accurate, minimally invasive alternative to add clarity and confidence in the diagnosis of neurodegenerative diseases. The company has research collaborations with multiple biopharmaceutical companies and is committed to advancing science in the field. For more information visit www.cndlifesciences.com.
Disclosure: Research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number R44NS117214. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.