[Federal Register Volume 85, Number 44 (Thursday, March 5, 2020)]
[Notices]
[Pages 12934-12935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04535]


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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unpublished information related to the invention.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:

Tau RT-QuIC: Ultrasensitive Assays for the Detection of Tau Seeding 
Activity Associated With Tauopathies

    Description of Technology:
    Tauopathies are a category of neurodegenerative diseases defined by 
the abnormal accumulation of misfolded tau protein aggregates (often in 
the form of amyloid filaments) within the brain. Tau proteins exist in 
six isoforms, three of which contain three microtubule binding regions 
(3R), and the remainder contain four microtubule binding regions (4R). 
Tauopathies are characterized, in part, based on the ratio of 3R/4R 
misfolded tau proteins that make up the aggregates. This technology 
enables rapid, ultrasensitive and economical differentiation of self-
propagating tau aggregates associated with tauopathies in crude 
biospecimens. The assays use recombinant, truncated 3R, 4R, or 3R+4R 
tau protein substrates as indicators of tau aggregates. Specifically, 
misfolded tau aggregates (contained in a biological sample) seed the 
polymerization of either 3R, 4R, or 3R+4R tau substrates, and the 
polymers (amyloid fibrils) are detected as an amplified indicator of 
even extremely low concentrations of tau aggregates within the 
biological sample and aid in identification of the tauopathy. In its 
current embodiment, this assay has been used to detect tau seeds in 
brain tissue from patients with Alzheimer's disease, Pick disease, 
chronic traumatic encephalopathy, corticobasal degeneration, 
progressive supranuclear palsy, certain frontotemporal dementias, and 
other tauopathies. For several of these diseases, tau RT-QuIC assays 
have also detected tau seeding activity in patients' cerebrospinal 
fluid.
    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:
 Diagnosis of tauopathies, including: Alzheimer's disease, Pick 
disease,

[[Page 12935]]

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 [email protected], and 
reference E-015-2017-0.

    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. 2020-04535 Filed 3-4-20; 8:45 am]
BILLING CODE 4140-01-P