CND Life Sciences has announced that the US 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 US FDA's breakthrough devices programme is intended to expedite the development and US FDA review of medical devices granted Breakthrough Device Designation (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 US FDA experts through several different programme options to efficiently address topics as they arise during development, as well as senior US FDA management engagement and priority review for pre-market submissions for designated devices.  

CND Life Sciences 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 fiber density as a marker of peripheral nerve degeneration.

"We are very pleased to receive the Breakthrough Device Designation from the US FDA as we advance the clinical application and science of Syn-One to help move the neurodegeneration field forward. Synucleinopathies, which include Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy, are often challenging to diagnose given the diverse mix of clinical features that develop over many years. As an LDT, the Syn-One Test continues to serve as a valuable, minimally invasive tool for clinicians to increase their diagnostic confidence and make more precise treatment decisions for patients," said Christopher Gibbons, Chief Scientific Officer and Co-Founder, CND Life Sciences.

In 2024, CND published a key study in the Journal of the American Medical Association demonstrating Syn-One's 95.5 percent overall sensitivity in detecting abnormal synuclein in patients diagnosed with the three different synuclein-associated diseases. In August 2025, a team of neurologists and researchers at Yale University published an important clinical utility study in Movement Disorders Clinical Practice indicating that, through a retrospective chart review, the use of the Syn-One Test changed the diagnosis in 52 percent of cases and the medical management in 60 percent of 149 evaluable patients.

"We look forward to working with the US FDA as we progress with the Breakthrough Device Designation with the goal of a future filing. Backed by more than a decade of published research, we are proud of the work CND has done to bring the Syn-One Test as an LDT to clinicians and patients nationally and will continue to support the need for accurate and convenient tools to aid in the diagnosis of synuclein-associated disorders," said Todd Levine, Chief Medical Officer and Co-Founder, CND.