The U.S. Department of Health and Human Services will support development of a rapid blood test for anthrax infection that can be used by mainstream health care laboratories following an anthrax attack. The test is the first for anthrax to be supported by the Biomedical Advanced Research and Development Authority (BARDA) in the HHS Office of the Assistant Secretary for Preparedness and Response.
Diagnostic tests play a critical role in the early and accurate detection of anthrax infection. With a rapid, accurate blood test, health care providers would be able to identify people who are ill as early as possible, provide the appropriate medical treatment to save lives, and minimize unnecessary use of medication or hospitalization.
If cleared by the U.S. Food and Drug Administration, the test could fill this need and be used in labs in the affected area after an anthrax release was detected by routine bioterrorism surveillance and confirmed by state and local laboratories.
“This project is the first that BARDA will sponsor to develop new diagnostics for biothreats for use during public health emergencies,” said BARDA Director Robin Robinson, Ph.D. “Quickly identifying people exposed to anthrax is crucial to providing appropriate care.”
The contract for advanced development of the rapid blood test is with MRIGlobal of Kansas City, Mo., for 15 months and approximately $1.6 million . The development work includes studies needed to apply for FDA approval of the test for use on a commercially available laboratory testing instrument, the ABI7500 Fast Dx, made by Life Technologies, Inc. of Carlsbad, Calif.
MRIGlobal and Life Technologies will collaborate in the development of this test. The ABI7500 Fast Dx is used in health care laboratories around the country for routine identification of bacteria and viruses that cause disease, such as influenza.
While the project focuses on developing the laboratory diagnostic test, once development is complete and the test is cleared by FDA, the company or the federal government could make test kits available to commercial healthcare laboratories in a public health emergency. Training and drills with health care laboratory personnel could be conducted on a regular basis using the test.
The project could be extended for up to a total of five years and approximately $12 million. If extended, MRIGlobal would expand development of the anthrax test for use with additional testing instruments, as well as design tests for other biothreats.
The project is the latest in BARDA’s biodiagnostics program and part of BARDA’s comprehensive, integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. In addition to radiological and nuclear agents, these threats include chemical and biological terrorism threats, pandemic influenza, and emerging infectious diseases.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
Source: Health and Human Services