Global & Disaster Medicine

The first blood test for anthrax that could show results within minutes at a doctor’s office or ER will take the final steps in development

HHS

May 9, 2016

Contact: HHS Press Office
202-690-6343
media@hhs.gov
HHS sponsors point-of-care anthrax diagnostic test
Simple, fast finger-prick blood test could aid in medical response to bioterrorism attack.

The first blood test for anthrax that could show results within minutes at a doctor’s office or emergency room will take the final steps in development with support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).

Under an 18-month $2.5 million agreement with ASPR’s Biomedical Advanced Research and Development Authority (BARDA), SRI International of Menlo Park, California, will conduct studies necessary to ensure the test accurately detects anthrax infections in blood samples; the studies are needed to apply for clearance to market the device from the U.S. Food and Drug Administration. The contract can be extended for up to a total of three years and $7.8 million.

The test being developed is based partly on a similar version developed at the Centers for Disease Control and Prevention (CDC). Anthrax diagnostic tests available today require sending samples to a laboratory for analysis, with results available in days.

The test SRI is developing uses blood samples on small cartridges; after 15 minutes, the cartridge is placed in a reader, and results are displayed. This compact system fits into the palm of a hand and can be used in locations close to the patient, such as hospital emergency rooms, local health clinics, and potentially at the patient’s bedside or by first responders.

Having the results immediately available will help doctors make fast decisions about the appropriate care and treatment for patients who may have been exposed to anthrax, particularly after an anthrax bioterrorism attack. Anthrax is an acute disease caused by Bacillus anthracis bacteria, and if untreated can be deadly. The inhaled form can cause death in a matter of days.

SRI International will work with DCN Diagnostics of Carlsbad, California, and Web Industries of Holliston, Massachusetts, on regulatory, design, and manufacturing studies of the anthrax diagnostic test.

BARDA, CDC and other federal agencies coordinate as a Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) to prioritize medical countermeasures – drugs, vaccines, and diagnostics – needed in public health emergencies, identify promising medical countermeasures, and transition products from early development to advanced development with the goal of FDA approval.

Protecting health after an anthrax attack requires preventing, detecting, and treating anthrax infections. To meet this national health security need, BARDA’s portfolio includes development of three anthrax antitoxin drugs that have been approved by FDA. BARDA also is supporting advanced development of vaccines to prevent illness after exposure to anthrax as well as improvements on the only vaccine licensed for use prior to exposure so that fewer doses are needed to protect health.

BARDA is seeking additional proposals for advanced development of new drugs and products to diagnose, prevent, treat, and protect health against chemical, biological, radiological or nuclear threats. Proposals are accepted through the Broad Agency Announcement BARDA-CBRN-BAA-13-100-SOL-00013, available on fbo.gov.

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. 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.

To learn more about ASPR and BARDA, as well as preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, phe.gov and the HHS emergency medical countermeasures website, medicalcountermeasures.gov.

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