FDA Grants Breakthrough Status to CND Life Sciences’ Cutaneous Neurodiagnostic Test

CND Life Sciences, Inc. (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for the company's Syn-One Test for aiding the diagnosis of synucleinopathies in patients aged 40 years and older with neurologic conditions that present with clinical features suggestive of a synucleinopathy.

The FDA's Breakthrough Devices Program is intended to expedite the development and FDA review of medical devices granted BDD. To qualify for BDD, a device must meet two main criteria: first, evidence must establish a reasonable expectation that a device could provide more effective treatment or diagnosis for a life-threatening or irreversibly debilitating condition, and second, it must satisfy one of four sub-criteria, such as representing a breakthrough technology, having no approved alternatives, offering significant advantages over existing alternatives, or having its availability be in the best interest of patients. BDD offers device developers opportunities to interact with FDA experts through several different program options to efficiently address topics as they arise during development, as well as senior FDA management engagement and priority review for premarket submissions for designated devices.   

CND launched the Syn-One Test as a laboratory-developed test (LDT) in late 2019. Since then, neurologists and other clinicians have ordered it for nearly 50,000 patients in all 50 states and in a variety of clinical settings, including community practices, academic medical centres, and large health systems. Through a routine office-based procedure, Syn-One uses three small skin biopsy samples collected from three specific anatomical locations on each patient to identify the abnormal, phosphorylated alpha-synuclein (P-SYN) protein in cutaneous nerves, while also measuring intraepidermal nerve fibre density as a marker of peripheral nerve degeneration.