[Federal Register Volume 85, Number 44 (Thursday, March 5, 2020)]
[Notices]
[Pages 12933-12934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04536]


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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

[[Page 12934]]

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unpublished information related to the invention.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:

A Rapid Ultrasensitive Assay for Detecting Prions Based on the Seeded 
Polymerization of Recombinant Normal Prion Protein (rPrP-sen) 
Description of Technology

    Prion diseases are neurodegenerative diseases of great public 
concern as humans may either develop disease spontaneously or, more 
rarely, due to mutations in their prion protein gene or exposures to 
external sources of infection. Prion disease is caused by the 
accumulation in the nervous system of abnormal aggregates of prion 
protein. This technology enables rapid, economical, and ultrasensitive 
detection of disease-associated forms of prion protein. Specifically, 
prion aggregates (contained in a biological sample) seed the 
polymerization of recombinant, monomeric prion protein (rPrP-sen) and 
the polymerized product is detected as a highly amplified indicator of 
infectious prions in the sample. This assay differs from the protein-
misfolding cyclic amplification assay (PMCA) because it enables the 
effective use of bacterially expressed rPrP-sen and does not require 
multiple amplification rounds. In its current embodiment, this assay 
can be used to detect prions in tissues or fluids from humans 
(Creutzfeldt-Jakob disease (CJD)), sheep (scrapie), cattle (bovine 
spongiform encephalopathy), and deer (chronic wasting disease (CWD)). 
For example, analyses of cerebrospinal fluid and/or nasal brushings 
from living sporadic CJD patients has allowed for nearly 100% accurate 
diagnosis.
    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:
     A test/screen for infectious prions in live animals and 
food products
     Cervid CWD monitoring
     A human diagnostic for early detection of prion diseases
     Medical equipment screening
     A monitor for effectiveness of treatments or disease 
progression
     A high through-put screen for inhibitors of prion 
replication
Competitive Advantages:
     Uses a consistent, concentrated source of normal prion 
protein (rPrP-sen)
     Prions are detectable to low levels after a single 
amplification round
     Demonstrated to be effective at detecting prions from 
different species
     May be applicable to blood products, nasal brushings, 
skin, eye components and other accessible biospecimens
     Economical and rapid
Development Stage:
     Research Use

    Inventors: Ryuichiro Atarashi (NIAID), Roger Moore (NIAID), Byron 
Caughey (NIAID).
    Publications: Atarashi, Ryuichiro et al. ``Simplified 
ultrasensitive prion detection by recombinant PrP conversion with 
shaking.'' Nature Methods 5, pages 211-212 (2008).
    Licensing Contact: To license this technology, please contact 
Jeffrey Thruston at 301-594-5179 or [email protected], and 
reference E-109-2007-0.

    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. 2020-04536 Filed 3-4-20; 8:45 am]
 BILLING CODE 4140-01-P