[Federal Register Volume 87, Number 142 (Tuesday, July 26, 2022)]
[Notices]
[Page 44413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15910]



[[Page 44413]]

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

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: Theodoric Mattes at 240-627-3827, 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unpublished information related to the invention.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:

Lymphatic Filariasis Biomarkers for Detection and Surveillance

    Description of Technology:
    Lymphatic filariasis (elephantiasis; LF) is a neglected tropical 
disease that affects over 120 million people throughout the tropics and 
subtropics of Asia, Africa, the Western Pacific, and parts of the 
Caribbean and South America. LF results from infection with the 
filarial parasites Wuchereria bancrofti or Brugia malayi. Current 
methods of confirming active infection by W. bancrofti or B. malayi 
include microscopy and immunoassays using serum/plasma extracted from 
the patient. However, the sensitivity of microscopy detection varies 
among patients, and immunoassays show cross-reactivity with antibodies 
directed towards other parasites, such as Onchocerca volvulus or Loa 
loa whose geographic distribution can overlap with the LF-causing 
filarial parasites.
    This new technology addresses the limitations of cross-reactivity 
through the detection of a single antigen, Wb5B, selected due to a lack 
of homologs in other filarial parasites that infect humans. Preliminary 
data indicates that Wb5B is immunogenic, highly specific (>99%), and 
accurate (>90%) for the detection of W. bancrofti infection in sera 
from humans and other mammalian sources. The antigen can be isolated in 
soluble form for integration in a variety of diagnostic assay formats.
    The subject technology, including the antigen sequence as well as 
plasmids enabling bacterial, insect, and mammalian cell expression, is 
available for licensing for commercial development in accordance with 
35 U.S.C. 209 and 37 CFR part 404, as well as for further development 
and evaluation under a research collaboration.
    There may be the potential to combine this technology with another 
NIAID-developed biomarker technology (Wb123, available for licensing; 
see HHS Ref. No. E-281-2010-0, ``Diagnostic Assays and Methods of Use 
for Detection of Filarial Infection'') for the development of a 
multiplex assay for detection of active W. bancrofti infection for 
diagnostic or surveillance purposes.
    Potential Commercial Applications:

 Diagnostics for W. bancrofti infection
 Surveillance for W. bancrofti prevalence

    Competitive Advantages:
 Increased specificity compared to available diagnostics
 Differentiation from other parasites with similar geographic 
footprints

    Development Stage: Pre-Clinical.
    Inventors: Thomas B. Nutman, Sasisekhar Bennuru, both of NIAID.
    Intellectual Property: U.S. Provisional Patent Application Serial 
No. 63/347,794, filed June 1, 2022.
    Related Inventions: Diagnostic Assays and Methods of Use for 
Detection of Filarial Infection (HHS Reference No. E-281-2010-0).
    Licensing Contact: To license this technology, please contact 
Theodoric Mattes at 240-627-3827, or [email protected]., and 
reference E-093-2022-0.
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize this technology. For collaboration 
opportunities, please contact Theodoric Mattes at 240-627-3827, or 
[email protected].

    Dated: July 14, 2022.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2022-15910 Filed 7-25-22; 8:45 am]
BILLING CODE 4140-01-P