CND Life Sciences has achieved two significant regulatory and research milestones for its Syn-One Test, a novel skin biopsy diagnostic tool for synuclein-associated neurodegenerative diseases. The company received FDA Breakthrough Device Designation and secured a $3 million NIH grant to advance research into Parkinson's disease risk prediction.
FDA Breakthrough Device Recognition
The FDA's Breakthrough Devices Program designation expedites development and review of medical devices that may provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. The Syn-One Test received this designation for aiding the diagnosis of synucleinopathies in patients aged 40 years and older with neurologic conditions presenting clinical features suggestive of a synucleinopathy.
"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."
Clinical Performance and Validation
The Syn-One Test demonstrated robust clinical performance in multiple studies. In 2024, CND published a key study in the Journal of the American Medical Association showing the test's 95.5% overall sensitivity in detecting abnormal synuclein in patients diagnosed with three different synuclein-associated diseases. The prospective, multicenter NIH-sponsored study demonstrated greater than 95% sensitivity and specificity in patients with clinically determined synucleinopathy.
A clinical utility study published in August 2025 by Yale University neurologists and researchers in Movement Disorders Clinical Practice revealed significant diagnostic impact. Through retrospective chart review, the Syn-One Test changed diagnosis in 52% of cases and medical management in 60% of 149 evaluable patients.
NIH Grant for Essential Tremor Research
CND received a $3 million grant from the National Institutes of Health Small Business Innovation Research program to conduct the "Syn-T Study," investigating whether phosphorylated alpha-synuclein presence in essential tremor patients predicts Parkinson's disease development risk.
"This is our fourth NIH-SBIR grant award over the last five years and a real testament to our scientific foundation and proven ability to bring important neurodiagnostic innovations from bench to bedside," said Dr. Levine. "There are an estimated seven million people in the U.S. with ET, and the risk of developing PD can be significantly higher in people with ET than in the general population."
Study Design and Clinical Significance
The three-year multicenter study will enroll approximately 300 participants across 15 U.S. sites, with recruitment beginning in December 2025. The study will be conducted under direction of Baylor University Medical Center, University of Texas Southwestern Medical Center in Dallas, and Beth Israel Deaconess Medical Center in Boston.
Essential tremor affects more than five percent of people over age 65 and is associated with increased risk of phenoconverting into Parkinson's disease. The involuntary rhythmic shaking impacts quality of life and can lead to disability.
"Using this technology, we aim to prove that individuals with ET who have positive Syn-One Test results are significantly more likely to develop PD," said Christopher Gibbons, MD, FAAN, chief scientific officer and co-founder of CND, professor of Neurology at Harvard Medical School, and principal investigator of the study.
Diagnostic Technology and Clinical Adoption
The Syn-One Test uses proprietary immunofluorescence techniques to detect, visualize and quantify phosphorylated alpha-synuclein in cutaneous nerves. The test analyzes three small skin biopsy samples collected from specific anatomical locations through a routine in-office procedure, including assessment of intraepidermal nerve fiber density and other pathologic markers.
More than 3,000 neurologists and other clinicians in 50 states have used the Syn-One Test to support diagnostic evaluation of patients with synucleinopathies including Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy. CND operates a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, offering the test as a laboratory developed test.
