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

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.

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

Inventors:

Byron Caughey (NIAID)  ➽ more inventions...

Bradley Groveman (NIAID)  ➽ more inventions...

Christina Groveman (NIAID)  ➽ more inventions...

Lynne Raymond (NIAID)  ➽ more inventions...

Andrew Hughson (NIAID)  ➽ more inventions...


Intellectual Property:
PCT Application No. PCT/US2018/052968
US Application No. 62/567,079
US Application No. 16/652,804

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

Collaboration Opportunity:
To license this technology, please contact Jeffrey Thruston at 301-594-5179 or jeffrey.thruston@nih.gov, and reference E-233-2017-0.


Licensing Contact:
Jeffrey Thruston,
Email: jeffrey.thruston@nih.gov
Phone: 301-594-5179

OTT Reference No: E-233-2017-0
Updated: May 29, 2020