New Peer-Reviewed Study Demonstrates Amprion's Seed Amplification Assay Can Differentiate Multiple System Atrophy from Parkinson's Disease Using Skin Biopsy Samples

Peer-reviewed findings published in npj Parkinson's Disease support the potential of skin-based alpha-synuclein seed amplification assays to differentiate multiple system atrophy from other neuronal synuclein diseases

SAN DIEGO--(BUSINESS WIRE)--Amprion, a global leader advancing diagnosis of neurodegenerative disorders through seed amplification testing, today announced publication of new peer-reviewed research in npj Parkinson's Disease, a Nature Portfolio journal, demonstrating that its skin-based α-synuclein seed amplification assay (skin SAA) can differentiate multiple system atrophy (MSA) from neuronal synuclein diseases (NSD), including Parkinson's disease (PD) and dementia with Lewy bodies (DLB), representing an important step toward expanding access to seed amplification-based biomarker testing for neurodegenerative disease.

The publication is the first to demonstrate that SAA can distinguish MSA from other synucleinopathies using skin biopsy samples, further expanding the potential applications of seed amplification technology beyond cerebrospinal fluid (CSF). The findings also support ongoing development of Amprion's α-synuclein skin SAA, which is currently available for research use with the goal of future clinical commercialization.

"Understanding the underlying biology of neurodegenerative disease is becoming increasingly important as new therapies emerge," said Russ Lebovitz, MD, PhD, CEO and Co-Founder of Amprion. "There remains a significant unmet need for highly specific, less invasive biomarkers for alpha-synuclein pathology. These findings demonstrate that seed amplification assays continue to show promise for detecting misfolded proteins across multiple specimen types and move us closer to a future where important biological information may become available through less invasive approaches."

Seed amplification assays detect misfolded α-synuclein aggregates associated with synucleinopathies, including Parkinson's disease, dementia with Lewy bodies, mixed-pathology Alzheimer's disease, and multiple system atrophy. While Amprion's clinically available SAAmplify-αSYN Plus test currently analyzes CSF, the newly published research demonstrates the feasibility of skin SAA for detecting and differentiating disease-associated pathology in skin biopsy samples.

According to the study, Amprion's α-synuclein skin SAA successfully differentiated specimens from patients with MSA versus neuronal synuclein disease (NSD) while demonstrating strong agreement with corresponding CSF findings.

Additional analyses presented in the publication demonstrated:

• Strong concordance between skin and CSF SAA testing among patients with prodromal Parkinson's disease
• Increasing skin SAA positivity as Parkinson's disease progresses
• High concordance among dementia with Lewy bodies samples evaluated through international research collaborations
• No skin-positive cases subsequently tested negative by CSF analysis in the blinded comparator samples

The publication marks another milestone in Amprion's strategy to advance seed amplification-based precision diagnostics across multiple neurodegenerative diseases. Building on its commercially available CSF testing platform, the company plans to showcase its α-synuclein skin SAA for research use at the upcoming International Congress of Parkinson's Disease and Movement Disorders in Seoul, Korea in early October while advancing the assay toward planned clinical commercialization in the United States over the next 12 months.

The publication also reflects Amprion's growing leadership in seed amplification-based neurodegenerative diagnostics. Most recently, the company was recognized as a Top 10 Winner in the 2026 Longevity Breakthrough Awards, honoring innovations with the potential to advance healthy aging and improve clinical care.

About SAAmplify-αSYN Plus

SAAmplify-αSYN Plus (CSF) is Amprion’s next-generation qualitative Laboratory Developed Test designed and validated to detect misfolded alpha-synuclein aggregates in cerebrospinal fluid. The assay provides evidence to aid in the diagnosis of synucleinopathies such as Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, and Alzheimer’s disease with Lewy body co-pathology.

About Amprion

Amprion is the global leader advancing diagnosis of neurodegenerative disorders through seed amplification testing, accelerating precision medicine for neurodegenerative disorders by helping biopharma partners identify new drug candidates and underlying pathologies. Amprion's intellectual property surrounding seed amplification assay (SAA) methodology extends to research, drug development and commercialization.