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  5. Mouse Monoclonal Antibodies Specific to Trypanosoma Cruzi Antigens
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Mouse Monoclonal Antibodies Specific to Trypanosoma Cruzi Antigens

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Technology Summary

Trypanosoma cruzi (T. cruzi) is the causative parasite agent of Chagas disease. Although, two drugs, Benznidazole (BZ) and Nifurtimox (NFX) are used to treat Chagas disease, treatment rarely results in a complete cure. T. cruzi infections are a chronic and lifelong disease with serological assays remaining positive over the lifetime of the infected host. Assays that detect biomarkers correlated with reduced parasitemia or parasite load after drug treatment are needed. Reduced levels of parasite biomarkers, such as secreted antigens would aid in the determination of drug efficacy.

FDA researchers have developed monoclonal antibodies (mAbs) against six T. cruzi antigens that are specific to their respective targets and show high binding affinities in the range of 1 x10-9 to <1.0 x10-12M. These T. cruzi mAbs can potentially be used to develop assays to detect antigens in T. cruzi patients either as a diagnostic test or an antigen assay to confirm disease status in Chagas patients. Currently, no assays that detect T. cruzi secreted antigens are available on the market.

Potential Commercial Applications Competitive Advantages
  • Research tool
  • Diagnostic test for Chagas Disease
  • Antigen tests to confirm disease status 
  • T. cruzi antigen specific monoclonal antibodies

 

Development Stage:

  • Development assays to detect T. cruzi in mice and Chagas patients

Inventors:

  • Alain Debrabant, Rana Nagarkatti, David Acosta

Publications:

  • Nagarkatti, R. et. al. A novel Trypanosoma cruzi secreted antigen as a potential biomarker of Chagas disease. Sci Rep. 2020 Nov 11;10(1):19591. PMID: 33177582

Product Area:

  • Research materials, monoclonal antibodies, Trypanosoma cruzi, Chagas

Licensing Contact:

Ken Millburne
FDA Technology Transfer Program
Email: FDAInventionlicensing@fda.hhs.gov
Phone: 240-402-2245

FDA Reference No: E-2020-014

 

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