Use of Skin Biopsy Test Reduces Neurological Health Care Costs in Suspected Synucleinopathies

A new study presented at the recently concluded 2026 AD/PD International Conference on Alzheimer’s and Parkinson’s Diseases, held March 17-21 in Copenhagen, Denmark, showed that the use of skin biopsy detection of phosphorylated α-synuclein (P-SYN) in patients with suspected synucleinopathies was associated with a reduction in neurological health care costs. Results of the study revealed that cost reductions were primarily attributable to decreased use of neuroimaging, laboratory testing, and physician referrals.¹

Presented by senior author Christopher Gibbons, MD, co-founder and chief scientific officer at CND Life Sciences, and colleagues, the study included 100 patients with suspected synucleinopathy (women, n = 50; mean age, 73 years [SD, 8]). Authors noted that the evaluation time prior to P-SYN testing was 26.1 months (SD, 10.3), and the follow-up period was 14.6 months (SD, 6.8). Overall, a total of 599 tests and referrals were ordered, with 69% ordered before cutaneous P-SYN testing (n = 413).

This retrospective chart review of clinical care costs was conducted to evaluate the health economic impact of skin biopsy detection of P-SYN, using CND Life Sciences’ Syn-One Test, in patients with suspected synucleinopathy in a private neurology practice. Researchers reviewed records to quantify neurologic diagnostic procedures, tests, treatments, and referrals before and after P-SYN testing. Average test costs in the Louisville, Kentucky, region were used to calculate the financial burden for each patient. Investigators annualized the final estimated costs to account for differences in treatment duration and follow-up.

“The purpose of this study was to define the clinical utility of skin biopsy detection of α-synuclein in the diagnostic evaluation of patients with suspected synucleinopathies. Specifically, to understand whether incorporating cutaneous P‑SYN testing into the diagnostic process influenced downstream neurological care costs, including the use of imaging, laboratory testing, treatments, and specialist referrals,” Gibbons told NeurologyLive^®. “By comparing health care utilization and costs before and after P‑SYN testing, the study aimed to determine whether earlier biological confirmation could reduce unnecessary or duplicative diagnostic procedures and overall financial burden.”

READ MORE: Smartphone Typing Metrics Show High Reliability as Digital End Points in Phase 2b LUMA Study of BIIB122

Findings demonstrated significant reductions in all test categories were noted after cutaneous P-SYN testing (P <0.01 all groups). For example, 89 MRI’s and 20 DaTscan’s were ordered prior to P-SYN testing; 23 MRI’s and 6 DatScan’s were ordered after P-SYN testing. Neurological health care costs for the entire study of the 100 patients was $587,000 with $172,000 more spent prior to cutaneous P-SYN testing. To account for differences in follow-up, costs were annualized. Health care expenditure for these 100 patients decreased by $100,521 per year after cutaneous P-SYN testing.

“The findings align with several recent publications demonstrating that skin biopsy detection of α-synuclein can meaningfully influence the clinical diagnosis of diseases that are often difficult to diagnose and treat,” Gibbons added. “For clinicians, these results suggest that incorporating skin biopsy detection of P‑SYN earlier in the diagnostic workup of suspected synucleinopathies may help streamline clinical decision‑making, reduce reliance on repeated or high‑cost diagnostic testing, and limit unnecessary referrals. Beyond cost savings, this may also translate into a more efficient diagnostic journey for patients, reducing prolonged uncertainty and extensive testing without compromising care.”

Significant reductions in all test categories were observed after cutaneous P-SYN testing (all groups, P <.01). For example, authors noted that 89 MRIs and 20 DaTscans were ordered prior to testing, whereas 23 MRIs and 6 DaTscans were ordered afterward. Overall, the total neurological health care costs for the 100 patients were $587,000, with $172,000 more spent prior to cutaneous P-SYN testing. Moreover, health care expenditure for these 100 patients decreased by $100,521 per year after cutaneous P-SYN testing.

“Further research should focus on long‑term patient outcomes and benefits, including how earlier or more accurate diagnosis using skin biopsy impacts disease management, quality of life, and overall healthcare utilization over time,” Gibbons told NeurologyLive.

In October 2025, the FDA granted breakthrough device designation to the Syn-One Test for aiding the diagnosis of synucleinopathies among patients 40 years and older whose neurologic conditions present with suggestive clinical features of a synucleinopathy.² Since its 2019 launch, the Syn-One Test has been utilized for nearly 50,000 patients across various clinical settings in the US. The routine in-office procedure analyzes 3 small skin biopsies from specific anatomical locations to identify abnormal P-SYN in cutaneous nerves and measure intraepidermal nerve fiber density as an indicator of peripheral nerve degeneration.

Click here for more of our 2026 AD/PD coverage.

REFERENCES
1. Gibbons C, Levine T, Freeman R, et al. The Health Economics of Skin Biopsy Detection of Phosphorylated Alpha-Synuclein in a Private Practice. Presented at: 2026 AD/PD International Conference on Alzheimer’s and Parkinson’s Diseases; held March 17-21; Copenhagen, Denmark. Abstract 2259.
2. CND Life Sciences Is Granted FDA Breakthrough Device Designation for Its Skin Biopsy-Based Syn-One Test. News release. CND Life Sciences. October 7, 2025. Accessed March 20, 2026. https://cndlifesciences.com/fda-breakthrough-device/