Scottsdale, AZ — November 6, 2025 : CND Life Sciences (CND) announced the completion of its 50,000th Syn-One Test®, a groundbreaking milestone for the company’s skin-biopsy-based diagnostic test designed to aid in the diagnosis of synucleinopathies such as Parkinson’s disease and Dementia with Lewy bodies. Since its commercial launch in 2019, the test has been used by more than 3,000 neurologists and clinicians across all 50 U.S. states, solidifying its role as a trusted clinical tool in the early detection and confirmation of neurodegenerative diseases.
Science Significance
The Syn-One Test® analyzes small skin biopsies taken from three anatomical sites to detect phosphorylated alpha-synuclein (p-SYN)—a key biomarker associated with multiple synucleinopathies. It also evaluates nerve fiber density and skin morphology, providing additional insights into peripheral nerve health. In the NIH-funded Synuclein-One Study, the test achieved over 95% sensitivity and specificity, demonstrating its strong accuracy and reproducibility in identifying patients with clinically confirmed synucleinopathies. This innovation represents a major scientific step toward biomarker-based precision diagnostics for neurological disorders that have historically relied on clinical observation alone.
Regulatory Significance
Developed and performed under a CLIA-certified and CAP-accredited laboratory, the Syn-One Test® complies with established quality and laboratory-developed test (LDT) standards. Reaching 50,000 clinical uses reinforces its regulatory credibility and real-world validation. As the healthcare community advances toward biomarker-driven diagnostic frameworks, the Syn-One Test® stands as an early example of an approved and validated LDT supporting both clinical diagnosis and research applications in neurodegenerative disease identification.
Business Significance
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Crossing the 50,000-test threshold marks strong commercial and clinical adoption of CND Life Sciences’ technology. Used by a rapidly expanding network of neurologists, the Syn-One Test® underscores the company’s success in scaling precision diagnostics nationwide. This milestone enhances CND’s market position in the neurodiagnostic testing segment, opening avenues for strategic collaborations with biopharma companies seeking validated biomarkers for clinical trials and drug development. The company’s growth reflects a successful translation of academic innovation into a sustainable medical technology business model.
Patients’ Significance
For patients and caregivers, the Syn-One Test® provides clarity and confidence in diagnosis, reducing the uncertainty and delays associated with complex neurological symptoms. The minimally invasive skin biopsy can be done in a simple office visit, avoiding hospital procedures or imaging limitations. Earlier and accurate diagnosis enables patients to access treatment sooner, participate in clinical trials, and make more informed decisions about disease management and lifestyle. This innovation empowers patients to move beyond symptomatic uncertainty toward personalized, timely care.
Policy Significance
The Syn-One Test® milestone highlights the growing policy relevance of biomarker-based diagnostics in neurology. As health systems and insurers increasingly recognize the value of early and precise disease detection, such diagnostic tools may influence reimbursement models, public health strategies, and clinical guideline updates for neurodegenerative diseases. It also reinforces the broader shift toward precision medicine policies, ensuring equitable access to advanced diagnostics that can improve outcomes and reduce long-term care costs associated with late or inaccurate diagnoses.
The achievement of 50,000 Syn-One Test® uses underscores CND Life Sciences’ leadership in advancing neurodiagnostic innovation. By combining clinical validation, accessibility, and scientific rigor, the company continues to transform how neurological diseases are diagnosed and managed. As neurodegenerative disorders become increasingly prevalent, CND’s milestone represents a significant contribution to modern healthcare — advancing early detection, guiding better treatments, and improving the lives of patients worldwide.
Source: CND Life Sciences press release
