Exposure and Activity Detection Assays for Anthrax Lethal Factor and Lethal Toxin

This CDC developed invention identifies an assay for extremely fast and sensitive detection of Bacillus anthracis lethal toxin (LTx), the toxin responsible for the lethal effects of anthrax infection. This assay has already been successfully tested in animals and will allow for early detection of anthrax exposure and screening of lethal factors to monitor anthrax toxicity, for example for vaccine trial candidates.

LTx is composed of two proteins, protective antigen (PA) and lethal factor (LF). In one scenario, the assay effectively detects LF by first using magnetic protein G beads to capture and concentrate LF in samples, then testing for LF on the bead by reacting it with a peptide substrate designed to mimic LF's natural target. By using techniques such as mass spectrometry, FRET or liquid chromatography, this test can check for LF rapidly and with extraordinary specificity and sensitivity. Methodology and basic assay validation have been confirmed in animals and naturally-exposed (by contaminated meat in a Bangladesh processing facility) human serum samples.

Potential Commercial Applications: Competitive Advantages:
  • Emergency anthrax exposure diagnostics
  • Testing of and research into anthrax therapeutics, vaccines
  • Biodefense, biosecurity
  • Livestock health screening
  • Rapid turnaround
  • Highly sensitive-detects picomolar toxin levels
  • Reproducible and quantitative anthrax lethal factor (LF) assessment
  • Easily adaptable for high-throughput screening of numerous specimens

Development Stage:
  • In vitro data available
  • In vivo data available (animal)
  • In vivo data available (human)
  • In situ data available (on-site)

Related Invention(s):


Conrad Quinn (CDC)  ➽ more inventions...

Anne Boyer (CDC)  ➽ more inventions...

John Barr (CDC)  ➽ more inventions...

Intellectual Property:
US Pat: 8,663,926 issued 2014-03-04
PCT Application No. PCT/US2007/004156 filed on 2007-02-15
US Application No. 11/675,233 filed on 2007-02-15
Various international filings pending or issued

Boyer AE, et al PMID 17929949
Boyer AE, et al PMID 19506008
Kuklenyik Z, et al. PMID 21302970
Boyer AE, et al. PMID 21908727

Licensing Contact:
Karen Surabian, J.D., M.B.A.
Email: karen.surabian@nih.gov
Phone: 301-594-9719

OTT Reference No: E-196-2013-0
Updated: Mar 3, 2017