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March 21, 2026Journal of Parkinson s Disease0 citationsOpen Access

Collaborative action for biomarker breakthroughs: Validating α-synuclein seed amplification assays in Parkinson's disease

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LOLuis MA OliveiraMFMark FrasierSHSamantha J. Hutten

Key Points

  • The aim is to validate the alpha-synuclein seed amplification assay as a biomarker for Parkinson's disease.
  • Community-driven collaboration among researchers supported by the Michael J. Fox Foundation.
  • Validation of the assay across various academic and industry groups.
  • Utilization of patient engagement and open science principles.
  • The assay shows potential for detecting abnormal synuclein biology in several neurodegenerative diseases.
  • Received FDA Letter of Support for use in clinical trials for Parkinson's disease.
  • Rapid progress in assay validation noted through collective research efforts.

Abstract

The alpha-synuclein seed amplification assay in cerebrospinal fluid is the first validated molecular measurement of alpha-synuclein biology in a living person. The SAA test is transforming our understanding of aging and neurodegenerative diseases by detecting abnormal synuclein biology, and data suggests SAA positivity can occur across Parkinson's disease, Alzheimer's disease, and Dementia with Lewy Bodies. To accelerate development of this important research tool, the Michael J. Fox Foundation proactively funded a community of researchers to work both independently and collaboratively, leading to rapid and iterative progress and validation. The collective validation of the assay across industry and academic groups culminated in a Food and Drug Administration Letter of Support for the test in clinical trials for PD. This article describes the principles that accelerated the development of the assay including patient engagement, collaboration, a commitment to open science through data, sample, and knowledge sharing, and showcases how an international community of experts rallied together towards a common goal.

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Cite This Study

Oliveira et al. (2026) studied this question.

synapsesocial.com/papers/69be35836e48c4981c673ceahttps://doi.org/10.1177/1877718x261431949
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