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U.S. Department of Health and Human Services

Anthrax Diagnostics

Advanced Development

In the event of an anthrax attack, healthcare professionals will need to quickly determine who has been infected.  Rapid diagnostics would enable public health professionals with critical information to guide triaging decisions and patient care in an emergency.

Current Programs

BARDA is supporting the advanced development of the following anthrax diagnostic products and platforms:

  • TangenDx Molecular Diagnostic System:  BARDA is supporting the development of the TangenDx Molecular Diagnostic System, a rapid, deployable anthrax diagnostic platform that, if approved, could be used to determine if a patient has been infected in as little as 1 hour. Prelimiary data indicate that the system could be as sensitive as current blood cultures with results hours quicker. This point-of-care diagnostic test can be based on a wide range of specimen types, including blood, sputum, and other methods of specimen sampling.
  • Inbio’s Point-of-Care Diagnostic Test:  This point-of-care diagnostic test, which may be able to determine if a patient has been infected with the bacterium that causes anthrax by analyzing finger stick blood in just 15 minutes, is currently under development and being supported by BARDA. The test could be used in hospital emergency rooms, local health clinics and at the patient’s bedside.
  • Lateral Flow Anthrax Lethal Factor Test by CDC and BBI Solutions:  If approved, this easy-to-use diagnostic test may be able to diagnose anthrax infection in just 15 minutes by analyzing finger stick blood.
  • Lateral Flow Anthrax Lethal Factor Test by SRI International:  In just 15 minutes, healthcare providers may be able to diagnose anthrax infections if this easy-to-use lateral flow anthrax lethal factor test by analyzing finger stick blood by SRI international is approved.

Future Directions

BARDA is interested in supporting the advanced development, clinical evaluation, and FDA clearance or approval of rapid, accurate point of care diagnostic systems for anthrax infection that are at a Technology Readiness Level of 4 or higher. To learn more, see the BARDA Broad Agency Announcement (AOI 7.2).

  • This page last reviewed: March 29, 2019