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Solving an Unmet Need: A New Diagnostic Paradigm for Neurodegenerative Disorders

By January 11, 2022 No Comments

Solving an Unmet Need: A New Diagnostic Paradigm for Neurodegenerative Disorders

Arriving at a definitive diagnosis of any given neurodegenerative condition is not always easy. Recent studies have shown that even in the hands of the best movement disorder specialists, patients diagnosed with Parkinson’s disease who come to autopsy show no evidence of Lewy bodies and have an alternate diagnosis 30% of the time. Similar data exist for patients with multiple sclerosis, Alzheimer’s disease, and immune-mediated neuropathies. These data tell us that clinical diagnostic skills and tests cannot always accurately distinguish the varied forms of neurodegenerative diseases.

CND Life Sciences was founded by practicing neurologists who understand the importance of arming physicians with key information and evidence to support diagnostic and therapeutic decision-making. Our primary area of focus is the family of neurodegenerative disorders knows as synucleinopathies: Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, pure autonomic failure, and REM sleep behavior disorder.

Research over the past three decades has demonstrated that the major protein in Lewy bodies is an abnormally phosphorylated form of alpha-synuclein (p-syn). Alpha-synuclein’s normal function is unknown, but it exists near the terminus of every nerve in the human body and is believed to have a key role in neurotransmitter release and function. In some cases, for unknown reasons, alpha-synuclein is phosphorylated, which causes the protein to fold incorrectly and results in deleterious effects on nerve cell function. Abnormal p-syn is now accepted as the earliest step in the development of the five synucleinopathies.

The search for a practical, reliable way to detect abnormal, phosphorylated alpha-synuclein deposition in a patient’s nervous system has been challenging. Biopsies of the colon and submandibular glands are invasive and difficult to perform. Blood, saliva, and other tissue forms have proved to be difficult vehicles for effective detection. DaTscans and PET scans are costly, not widely available, and lack high sensitivity and specificity.

CND Life Sciences has capitalized on the knowledge that p-syn exists in cutaneous nerve tissue and can be identified early in the disease process. Within a small piece of skin, we can visualize nerves that regulate blood vessels, sweat glands, pilomotor function, and sensory perception. The core methods of the Syn-One Test™ have demonstrated >95% sensitivity and specificity* based on internal QI/QA data and data presented by Gibbons et al at the American Academy of Neurology 2020 annual meeting.

With our Syn-One Test, CND Life Sciences is providing neurologists with critical and reliable information to support the diagnosis of synucleinopathies and set a foundation for optimal patient care.

*In patients with a clinically established synucleinopathy excluding REM sleep behavior disorder.

Learn more about the Syn-One Test