CND Life Sciences announced today that it will present findings from three clinical trials involving its cutaneous neurodiagnostic tool for dementia with Lewy bodies (DLB) and related disorders at the upcoming American Academy of Neurology 2025 Annual Meeting in San Diego from April 5-9.
The Scottsdale, Arizona-based medical technology company has developed the Syn-One Test, which uses skin biopsies to detect phosphorylated alpha-synuclein (P-SYN), a key biomarker in synucleinopathies such as DLB and Parkinson's disease.
Tracking Disease Progression Through Skin Biopsies
Two of the studies were led by Dr. Christopher Gibbons, Chief Scientific Officer and co-founder of CND Life Sciences and professor of Neurology at Harvard Medical School. These investigations tracked changes in cutaneous P-SYN over time in patients with DLB.
At the AAN meeting, Dr. Gibbons will present unblinded baseline data quantifying P-SYN deposition and blood P-Tau 217 in patients with suspected DLB and Alzheimer's disease at the mild cognitive impairment stage. His second study demonstrates that quantitative measures of cutaneous deposition suggest an annual increase in P-SYN deposition of 52% in patients with DLB.
"This research further highlights that skin biopsies offer a simple outpatient test to help clinicians detect and quantify changes in P-SYN in patients with DLB," said Dr. Gibbons. "Additionally, they can serve as a tool for pharmaceutical trials to ensure the right patients are enrolled and to provide the ability to measure change over time, aiding in the development of investigational therapies that seek to alter P-SYN deposition or aggregation."
Optimizing Diagnostic Accuracy
The third study, led by Dr. Todd Levine, Chief Medical Officer at CND Life Sciences, focused on determining the optimal number of skin biopsies needed for accurate detection of P-SYN. The research found that using fewer than three biopsies results in a clinically significant percentage of false negative tests, with the risk increasing as diagnostic certainty decreases.
Furthermore, the diagnostic discrimination provided by deposition pattern and distribution is compromised with fewer than three biopsies, potentially affecting clinical decision-making.
"The Syn-One Test is a reliable, evidence-based test designed to help clinicians accurately diagnose suspected synucleinopathies," said Dr. Levine. "Making an accurate diagnosis is critical for optimal patient care, and the Syn-One Test provides a minimally-invasive opportunity to obtain greater clarity in complicated diagnostic cases."
Clinical Significance and Market Adoption
The Syn-One Test analyzes three small skin biopsy samples collected through an in-office procedure and includes an assessment of intraepidermal nerve fiber density and other pathologic markers. The test employs proprietary immunofluorescence techniques to detect, visualize, and quantify phosphorylated alpha-synuclein in cutaneous nerves.
A recent prospective, multicenter NIH-sponsored study published in the Journal of the American Medical Association (JAMA) demonstrated that the Syn-One Test achieves greater than 95% sensitivity in patients with clinically determined synucleinopathy.
Approximately 2,500 neurologists and other clinicians across 49 states have already incorporated the Syn-One Test into their diagnostic evaluations. The company operates a CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona.
Implications for Drug Development
Beyond its diagnostic applications, CND Life Sciences is positioning the Syn-One Test as a valuable tool for pharmaceutical companies developing therapies for neurodegenerative diseases. The ability to accurately identify patients with synucleinopathies and monitor changes in P-SYN deposition over time could significantly enhance clinical trial design and execution.
The company is currently collaborating with biopharmaceutical partners on clinical trials for investigational therapies targeting neurodegenerative diseases and is conducting additional studies to assess the test's ability to provide early disease detection and prognostic insights.
As the prevalence of neurodegenerative disorders continues to rise with an aging population, innovative diagnostic tools like the Syn-One Test represent an important advancement in the field, potentially enabling earlier intervention and more personalized treatment approaches for patients with DLB and related conditions.
