CND Life Sciences is Granted FDA Breakthrough Device Designation for Its Skin Biopsy-Based Syn-One Test®
SCOTTSDALE, Ariz., Oct. 7, 2025 /PRNewswire/ -- CND Life Sciences, Inc. (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today 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 centers, 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 FDA as we advance the clinical application and science of Syn-One to help move the neurodegeneration field forward," said Christopher Gibbons, MD, FAAN, chief scientific officer and co-founder of CND. "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."
In 2024, CND published a key study in the Journal of the American Medical Association demonstrating Syn-One's 95.5% 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% of cases and the medical management in 60% of 149 evaluable patients.1
"We look forward to working with the FDA as we progress with the Breakthrough Device Designation with the goal of a future filing," said Todd Levine, MD, chief medical officer and co-founder of CND. "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."
About CND Life Sciences
CND Life Sciences supports the care of patients facing the potential diagnosis of neurodegenerative disease and other neurological conditions. Operating a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, CND developed the Syn-One Test to help clinicians diagnose synucleinopathies that include Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy. Syn-One uses proprietary immunofluorescence techniques to detect, visualize and quantify phosphorylated alpha-synuclein in cutaneous nerves. Results of a prospective, multicenter NIH-sponsored study of the Syn-One Test were published in the Journal of the American Medical Association (JAMA) in 2024 demonstrating >95% sensitivity and specificity in patients with a clinically determined synucleinopathy.2 For each patient, the test analyzes three small skin biopsy samples collected from three specific anatomical locations through a routine in-office procedure and includes an assessment of intraepidermal nerve fiber density and other important pathologic markers. More than 3,000 neurologists and other clinicians in 50 states have used the Syn-One Test to support their diagnostic evaluation of patients. The company also collaborates with biopharmaceutical companies on clinical trials for investigational therapies targeting neurodegenerative diseases and is conducting NIH-funded studies assessing the test's ability to provide early disease detection and prognostic insights. For more information, visit cndlifesciences.com or connect with us on LinkedIn.
1 Gummerson, C.E., Tinaz, S., Santini, V. and Zubair, A. (2025), Utilization of Skin Punch Biopsy for the Diagnosis of α-Synucleinopathy in Clinical Practice. Mov Disord Clin Pract. doi.org/10.1002/mdc3.70272 |
2 Gibbons CH, Levine T, Adler C, et al. Skin biopsy detection of phosphorylated α-synuclein in patients with synucleinopathies. JAMA. 2024;331(15):1298–1306. doi:10.1001/jama.2024.0792. |
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