Technology Bundle ID: TAB-3406

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

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Licensing Contact:
Primary Inventors: 
Byron Caughey (NIAID)
Co-Inventors: 
Andrew Hughson (NIAID), Bradley Groveman (NIAID), Christina Groveman (NIAID), Lynne Raymond (NIAID)
Institute or Center: 
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.

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
Advantages:
  • Uses a consistent, concentrated source of truncated alpha-synuclein protein substrate
  • Capable of disease detection prior to onset of symptoms
  • Rapid and economical

Patents

PCT Application PCT/US2018/052968
Filed on 2018-09-26
US Application 16/652,804
Filed on 2020-04-01
US Application 62/567,079
Filed on 2017-10-02

Publications

Groveman, Bradley R et al. “Rapid and ultra-sensitive quantitation of disease-associated α-synuclein seeds in brain and cerebrospinal fluid by αSyn RT-QuIC.” Acta Neuropathologica Communications vol. 6(1):7, 9 Feb. 2018.
PMID 29422107

Updated

May 29, 2020

Data Source: 
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