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CND Life Sciences Wins $2.4M NIH Grant to Develop Synucleinopathy Test

NEW YORK — CND Life Sciences said on Monday that it has been awarded a $2.4 million grant from the National Institutes of Health to support the clinical development of its Syn-One neurodegenerative disease test.

Syn-One is designed to detect and visualize abnormal phosphorylated alpha-synuclein — a hallmark of synucleinopathies such as Parkinson's disease, Lewy body dementia, and autonomic dysfunction — in cutaneous nerve fibers using skin biopsies. The test, which is commercially available, does not distinguish between synucleinopathies and is used to guide diagnosis in conjunction with a patient's other clinical features.

With the two-year grant, Phoenix-based CND Life Sciences plans to conduct a 500-patient, multicenter study to validate the sensitivity and specificity of skin biopsy detection of phosphorylated alpha-synuclein for diagnosing synucleinopathies, as well as to determine Syn-One's ability to differentiate between such diseases in combination with clinical data.

"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," CND Life Sciences Cofounder and Chief Medical Officer Todd Levine said in a statement.