Government-Owned Inventions; Availability for Licensing, 12935 [2020-04534]

Download as PDF Federal Register / Vol. 85, No. 44 / Thursday, March 5, 2020 / Notices corticobasal degeneration, chronic traumatic encephalopathy, progressive supranuclear palsy, and frontotemporal dementias with tau deposition. • Measurement of levels of pathological tau aggregates in biospecimens. • Analysis of tauopathy-associated disease progression • Clinical trial/drug development companion diagnostic Competitive Advantages: • Uses a consistent, concentrated source of truncated tau protein • Rapid and economical • Highly sensitive and specific Development Stage: • Research Use. Inventors: Byron Caughey (NIAID), Eri Saijo (NIAID), Allison Kraus (NIAID), Michael Metrick II (NIAID). Publications: Saijo, Eri et al. ‘‘Ultrasensitive and selective detection of 3-repeat tau seeding activity in Pick disease brain and cerebrospinal fluid’’. Acta Neuropathologica vol. 133 (2017):751–765. Kraus, Allison et al. ‘‘Seeding selectivity and ultrasensitive detection of tau aggregate conformers of Alzheimer disease’’. Acta Neuropathologica vol. 137, 4 (2019): 585–598. Metrick II Michael et al., ‘‘Million-fold sensitivity enhancement in proteopathic seed amplification assays for biospecimens by Hofmeister ion comparisons’’. Proc Natl Acad Sci USA vol. 116, 46 (2019):23029–23039. Saijo, Eri et al. ‘‘4-repeat tau seeds and templating subtypes as brain and CSF biomarkers of frontotemporal lobar degeneration’’. Acta Neuropathologica vol 139, 4(2020):63–77. Metrick II, Michael et al. ‘‘A single ultrasensitive assay for detection and discrimination of tau aggregates of Alzheimer and Pick diseases’’. Acta Neuropathologica Communications vol. 8, 1 (2020):22. Licensing Contact: To license this technology, please contact Jeffrey Thruston at 301–594–5179 or jeffrey.thruston@nih.gov, and reference E–015–2017–0. khammond on DSKJM1Z7X2PROD with NOTICES 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. 2020–04535 Filed 3–4–20; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 16:20 Mar 04, 2020 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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 jeffrey.thruston@nih.gov. 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: SUMMARY: 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 alphasynuclein 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 diseaseassociated 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 12935 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 Lewybody 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 asynuclein seeds in brain and cerebrospinal fluid by aSyn 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 jeffrey.thruston@nih.gov, 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 E:\FR\FM\05MRN1.SGM 05MRN1

Agencies

[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.

-----------------------------------------------------------------------

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

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