Grant Supports the Evaluation of CND’s Skin Biopsy Test to Identity Early Signs of Parkinson’s Disease and Other Neurodegenerative Disorders and Serve as an Effective Marker for Future Treatments
October 6, 2022 — Phoenix, AZ – CND Life Sciences, an innovative medical diagnostics company pioneering the detection, visualization, and quantification of protein deposition in cutaneous nerve fibers, has been awarded a $3 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH). This is the third NIH SBIR Phase II award for the company to study and advance the clinical application of the Syn-One Test, the only commercially available test that uses skin biopsies to help clinicians diagnose a synucleinopathy, a family of neurodegenerative diseases that includes Parkinson’s disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA), pure autonomic failure (PAF) and REM sleep behavior disorder (RBD).
RBD is one of the earliest pre-motor manifestations of neurodegenerative disease and is often present 10-15 years prior to diagnosis of PD, DLB or MSA. Patients diagnosed with RBD experience vivid, often disruptive dreams associated with simple or complex motor behavior during the REM phase of sleep. According to scientific literature, it is estimated that approximately 1% of the general population and 2% of older adults have RBD, and a majority of these individuals are at risk of converting to another synucleinopathy in their lifetimes.
“The results from this study could greatly expand the possibilities for Syn-One as a cutaneous neurodiagnostic test, as we explore the utility of identifying phosphorylated alpha-synuclein deposition in the prodromal stage of neurodegenerative diseases,” said Todd Levine, MD, CND’s Chief Medical Officer and principal investigator for the study. “Synucleinopathies represent a devastating group of diseases that evolve over many years and even decades. Being able to detect phosphorylated alpha-synuclein in patients with RBD could allow us to treat and even prevent debilitating diseases like PD and DLB before they fully develop. The success of future treatments for these disorders will be tied to how precisely and early we can understand the patient’s pathology,” explained Levine.
CND’s Syn-One Test uses three small skin biopsies, conveniently collected from a patient in a physician’s office, to accurately detect and visualize the presence of misfolded, phosphorylated alpha-synuclein, the abnormal form of a naturally-occurring protein that is the pathological hallmark of the synucleinopathies including RBD.
Titled the Syn-Sleep Study, CND’s 80-patient, multicenter clinical investigation will collaborate with the North American Prodromal Synucleinopathy Consortium (NAPS) who is conducting a larger, longitudinal research initiative with patients diagnosed with RBD. CND’s NIH-supported study aims to use the Syn-One Test and AI software to confirm the presence of phosphorylated alpha-synuclein in patients with clinically suspected RBD and predict the disease’s conversion to a more advanced synucleinopathy like PD and DLB. Achieving these aims would allow clinicians to use Syn-One as a reliable diagnostic tool early in the disease process and facilitate the application of disease-modifying therapies and other evidenced-based interventions for patients in the future.
“Identifying prodromal markers of neurogenerative disease is essential for research and clinical care,” says Dr. Mitchell Miglis, MD, Clinical Associate Professor of Neurology and Neurological Sciences and Psychiatry and Behavioral Sciences at Stanford University. “This is especially significant in those with RBD, a prodromal manifestation of synuclein-driven neurodegenerative disease that represents a window for potential therapy. Cutaneous alpha-synuclein, as measured in the Syn-One Test, is one such biomarker, and can be used to help confirm the underlying pathology in RBD, as well as to help identify patients for future clinical trials.”
About CND Life Sciences and the Syn-One Test
Founded in 2017, 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 Phoenix, 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 nerve fibers. The test, which analyzes small skin biopsies collected conveniently from the patient in a physician’s office, aids in the diagnosis of a synucleinopathy including Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, pure autonomic failure, and REM sleep behavior disorder. The Syn-One Test leverages a decade of published science from leading academic institutions in multiple countries and has demonstrated over 95% sensitivity and specificity (based on data presented at the 2020 AAN annual meeting). 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. For more information visit www.cndlifesciences.com.
There are over 20 million people in the US who suffer from movement disorders, cognitive impairment, autonomic dysfunction, and sleep disorders combined. A percentage of these patients exhibit signs and symptoms that may be indicative of a synucleinopathy, a group of serious neurodegenerative diseases including Parkinson’s and dementia with Lewy bodies, that universally feature a misfolded, abnormal form of the alpha-synuclein protein. 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 and cognitive disorders may misdiagnose these conditions at least 30% of the time early in the disease course when compared to gold standard autopsy studies.
Disclosure: Research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute on Aging (NIA) of the National Institutes of Health (NIH) 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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