SUPPLEMENTARY INFORMATION:

Technology description follows:

Compositions and Methods for Detecting Lymphatic Filariasis

Description of Technology

Lymphatic filariasis (elephantiasis; LF) is a neglected tropical disease characterized by painful deformation of the host. LF 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 ( printed page 67594) 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 existing 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 limitation of cross-reactivity, presenting an opportunity for a directed assay towards the detection of W. bancrofti or B. malayi. Preliminary data against sera from LF-affected individuals indicates Wb4 is effective at detecting B. malayi. Wb4B, a modified version of recombinant Wb4 that lacks the nineteen (19) amino acid signal sequence of full-length Wb4, appears capable of isolation and purification by traditional molecular biology techniques and shows improved response in immunoassays.

The subject technology, including the antigen sequence for Wb4B and 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 other NIAID-developed biomarker technologies (Wb123, available for licensing, HHS Ref. No. E-281-2010-0, “Diagnostic Assays and Methods of Use for Detection of Filarial Infection” and Wb5, available for licensing, HHS Ref. No. E-093-2022-0, “Compositions and Methods for Detecting Lymphatic Filariasis”) for the development of a multiplex assay for detection of active W. bancrofti or B. malayi infection for diagnostic or surveillance purposes.

Potential Commercial Applications:

• Diagnostics forW. bancrofti and B. malayi infection.
• Surveillance forW. bancrofti and B. malayi prevalence.

Competitive Advantages:

• Increased specificity compared to available diagnostics.
• Differentiation from other parasites with similar geographic footprints.

Development Stage:

• Pre-Clinical.

Inventors: Dr. Thomas B. Nutman and Dr. Sasisekhar Bennuru, both of NIAID.

Intellectual Property: HHS Reference No. E-067-2024-0. U.S. Provisional Patent Application No. 63/672,667, filed on July 17, 2024, and PCT Application No. PCT/US2025/037585, filed on July 17, 2025.

Related Inventions: Diagnostic Assays and Methods of Use for Detection of Filarial Infection (HHS Reference No. E-281-2010-0); Compositions and Methods for Detecting Lymphatic Filariasis (HHS Reference No. E-093-2022-0).

Licensing Contact: To license this technology, please contact Jonathan Motley at 240-669-5209, or jonathan.motley@nih.gov, and reference E-067-2024-0.

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 Jonathan Motley at 240-669-5209, or jonathan.motley@nih.gov.

91 FR 67593