PHOENIX, October 26, 2020 / PRNewswire / – Cutaneous NeuroDiagnostics (d / b / a CND Life Sciences), an innovative medical technology company pioneering the detection, visualization and quantification of protein deposits in skin nerve fibers, received an award $ 2.4 million Small Business Innovation Research (SBIR) Phase II Grant from the National Institute of Neurological Disorders and Stroke, National Institutes of Health (NIH). Todd Levine, MD, neuromuscular neurologist and co-founder and medical director of CND will serve as principal investigator (PI) on the two-year grant.
“We are honored to receive this prestigious grant from NIH,” said Dr. Levine. “The award will support the largest study of its kind aimed at improving the precision and clinical utility of our Syn-One test, which is adopted by neurologists to improve the diagnosis of neurodegenerative disorders, including Parkinson’s disease. “
The NIH grant enables CND to conduct a multicenter clinical study of 500 patients with leading neurologists and academic centers in the United States. The study aims to further validate the sensitivity and specificity of the Syn-One CND test to distinguish between different types of synucleinopathies. This large-scale scientific evaluation of the diagnostic approach and pathological methods of NDT will provide physicians and patients with even greater evidence to support wide clinical adoption of the Syn-One test.
“CND is committed to improving the way physicians diagnose and treat patients with signs and symptoms of neurodegenerative diseases, particularly early in the disease process,” said Richard Morello, Chairman and CEO, CND Life Sciences. “Advancing a convenient, minimally invasive test that can provide physicians and patients with a greater degree of confidence and accuracy in diagnosing difficult conditions such as Parkinson’s disease and Lewy body dementia will help the field to make a big step forward. “
About the Syn-One test
The Syn-One test draws on a decade of science published by global experts and carefully refined laboratory techniques to identify an abnormal form of a protein known as alpha-synuclein. By obtaining three small skin biopsies taken in the patient’s office by the patient’s clinician, the CND applies specialized methods to detect folded phosphorylated alpha-synuclein in the dermal layers of the skin. This abnormal form is a well-known biomarker for a family of diseases called synucleinopathies, the most important type being Parkinson’s disease. A physician ordering Syn-One receives a detailed report of the pathological results of the test, including visual images of the patient’s skin nerve fibers and a determination for the presence of abnormal synuclein.
In the United States, more than 20 million people suffer from movement disorders, cognitive impairment, autonomic dysfunction, and sleep disturbances. A percentage of these patients have signs and symptoms indicative of synucleinopathy, a group of serious neurodegenerative diseases, including Parkinson’s disease and Lewy body dementia, which universally present with abnormal alpha-synuclein. For some of these patients, the absence of objective pathological evidence makes the doctor’s diagnosis and therapeutic choices difficult to determine with certainty. Published studies suggest that even the most experienced neurologists specializing in movement disorders have difficulty making a positive diagnosis of Parkinson’s disease 30% of the time early in the course of the disease.
About CND Life Sciences
Founded in 2017, CND Life Sciences is dedicated to supporting the care of patients with neurodegenerative diseases and other related conditions. Operation of a CLIA certified laboratory in Phoenix, Arizona, CND launched the Syn-One Test ™, the world’s first commercially available test to detect, visualize and quantify the presence of abnormal phosphorylated alpha-synuclein in skin nerve fibers. The test is intended to serve as an objective and evidence-based diagnostic tool to aid in the confirmation of synucleinopathy in patients suspected of Parkinson’s disease (PD), Lewy body dementia (DLB), atrophy multisystem (MSA), pure autonomic insufficiency (PAF) or behavioral disorder in REM sleep (RBD). Thanks to the exclusive staining and analysis of three (3) small skin biopsies performed and provided by a referring clinician, CND offers a practical, precise and minimally invasive alternative to add clarity and confidence in the diagnosis of diseases. neurodegenerative. The company has research collaborations with several biopharmaceutical companies and is committed to advancing science in the field. For more information visit www.cndlifesciences.com.
Disclosure: The research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke at the National Institutes of Health under award number R44NS117214. The content is the sole responsibility of the authors and does not necessarily represent the official opinions of the National Institutes of Health.
SOURCE CND Life Sciences