CND Life Sciences has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its Syn-One Test®. This designation is intended to expedite the development and review of devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.
The Syn-One Test® is a laboratory-developed test that aids in diagnosing synucleinopathies, including Parkinson’s disease, dementia with Lewy bodies, and multiple system atrophy. It utilizes a minimally invasive procedure involving three small skin biopsy samples to detect abnormal phosphorylated alpha-synuclein (P-SYN) proteins in cutaneous nerves and assess intraepidermal nerve fiber density, a marker of peripheral nerve degeneration.
Since its launch in late 2019, the Syn-One Test® has been ordered by clinicians for nearly 50,000 patients across all 50 U.S. states. A study published in Movement Disorders Clinical Practice in August 2025 indicated that the test changed the diagnosis in 52% of cases and the medical management in 60% of 149 evaluable patients.
CND Life Sciences operates a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, and continues to support the need for accurate and convenient tools to aid in the diagnosis of synuclein-associated disorders.
