[Federal Register Volume 85, Number 44 (Thursday, March 5, 2020)]
[Notices]
[Page 12935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04534]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Jeffrey Thruston at 301-594-5179 or 
[email protected]. Licensing information may be obtained by 
communicating with the Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases, 5601 
Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

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

    Description of Technology: 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:
 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
    Development Stage:

 Research Use
    Inventors: Byron Caughey (NIAID), Bradley Groveman (NIAID), 
Christina Orru (NIAID), Lynne Raymond (NIAID)
    Publications: Groveman, Bradley R et al. ``Rapid and ultra-
sensitive quantitation of disease-associated [alpha]-synuclein seeds in 
brain and cerebrospinal fluid by [alpha]Syn RT-QuIC.'' Acta 
Neuropathologica Communications vol. 6(1):7, 9 Feb. 2018.
    Licensing Contact: To license this technology, please contact 
Jeffrey Thruston at 301-594-5179 or [email protected], and 
reference E-233-2017-0.

    Dated: February 25, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-04534 Filed 3-4-20; 8:45 am]
 BILLING CODE 4140-01-P