Technology Bundle ID
TAB-3406

Alpha-Synuclein RT-QuIC: An Ultrasensitive Assay for the Detection of Alpha-Synuclein Seeding Activity Associated with Synucleinopathies

Linked ID
E-233-2017-0
Lead Inventors
Byron Caughey (NIAID)
Co-Inventors
Andrew Hughson (NIAID)
Bradley Groveman (NIAID)
Christina Groveman (NIAID)
Lynne Raymond (NIAID)
ICs
NIAID
Synucleinopathies are a category of neurodegenerative diseases defined by the abnormal aggregation and accumulation of misfolded alpha-synuclein protein molecules within the brain. These aggregates are of particular concern to humans as they are a primary cause of Parkinson’s disease, dementia with Lewy bodies, and other neurological disorders. This technology enables rapid, economical and ultrasensitive detection of disease-associated forms of alpha-synuclein as biomarkers or indicators of synucleinopathy in a biological sample. Specifically, alpha-synuclein aggregates (contained in a biological sample) seed the polymerization of vast stoichiometric excesses of recombinant, normally folded alpha-synuclein into amyloid fibrils that are then detectable by an amyloid-sensitive fluorescent dye. This reaction can thereby amplify the seeds in a biospecimen by many orders of magnitude. For example, in its current embodiment, this assay has been used to detect alpha-synuclein seeds in cerebral spinal fluid from living patients with Parkinson’s disease and Lewy-body dementia, giving high diagnostic sensitivity and specificity with unprecedented speed.

This technology is available for licensing for commercial development in accordance with 35 U.S.C. § 209 and 37 CFR Part 404.
Commercial Applications
  • Pre-mortem diagnosis of synucleinopathies, including Parkinson’s disease and Lewy-body dementia
  • A monitor of the disease progression of dementia and synucleinopathies
  • Clinical trial / drug development companion diagnostic
Competitive Advantages
  • Uses a consistent, concentrated source of truncated alpha-synuclein protein substrate
  • Capable of disease detection prior to onset of symptoms
  • Rapid and economical

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