The US Department of Health and Human Services (HHS) has decided to support the research and development of a new point-of-care diagnostic test with the potential to identify anthrax infection within 15 minutes.
The Office of Assistant Secretary for Preparedness and Response (ASPR) division and the Biomedical Advanced Research and Development Authority (BARDA) have entered a three-year, $8.1m contract with medical diagnostic firm InBios International.
The firm will conduct clinical studies required for licensure application and pre-emergency use authorisation submission to the US Food and Drug Administration (FDA).
BARDA director Rick Bright said: “To save lives during an anthrax emergency, healthcare providers must be able to screen patients rapidly to provide treatment as quickly as possible.
“That’s our goal in supporting the development of point-of-care tests like this.”
InBio designed the test as a lateral flow immunoassay to identify specific bacterial proteins in a patient’s blood sample as a way of detecting an infection caused by Bacillus anthracis bacteria.
With the potential for use in hospital emergency rooms, local health clinics and at the patient’s bedside, the test is reported to have detected the bacterial proteins within approximately 15 minutes in previous studies.
In addition to its existing portfolio of anthrax antitoxin drugs, BARDA supports the development of vaccines to protect against illness following anthrax exposure.
The authority also seeks improvements to an existing anthrax vaccine that is licensed for post-exposure use.