With the Office of the Assistant Secretary for Preparedness and Response’s (ASPR) Biomedical Advanced Research and Development Authority (BARDA) support in the form of $5.5 million for the base period (16 months) and up to a total of $42.9 million over 10 years if all options are exercised, First Light Biosciences, Inc. of Bedford, Massachusetts will pursue the development of an anthrax diagnostic test for use in a doctor’s office, hospital, clinic or field setting that will provide results within 20 minutes.
In addition, the platform will also have the ability to test for multi-drug resistant anthrax infections.
Diagnosing anthrax infections quickly would aid doctors and other healthcare workers in providing life-saving antibiotics, anthrax antitoxins, and other necessary supportive care to infected patients. Anthrax victims initially exhibit flu-like symptoms, so it is vital after an event to distinguish victims in the early stages of anthrax infection from those with similar symptoms.
The diagnostic device that First Light Biosciences is developing will also be able to provide rapid antimicrobial susceptibility testing results within three to four hours, allowing for the early identification of drug-resistant anthrax. The earlier such infections are identified, the more quickly appropriate alternative therapy can be provided.
Meanwhile, also with support from BARDA, SRI International of Menlo Park, California is pursuing the development of clinically useful panels of blood-based biomarkers that could lead to faster and more accurate diagnostic tests for melioidosis, glanders and plague.
Operating under a $2.5 million base period (18 months) and up to a total of five years and $9.1 million if all options are exercised, SRI is developing a way to diagnosing biothreat pathogen infections quickly would help doctors and other healthcare workers isolate and provide necessary antibiotics and other supportive care to infected patients. The first phase of the contract will focus on melioidosis, followed by glanders and plague.
The test that First Light Biosciences is developing, called the MultiPath, detects the presence of anthrax within drops of the patient’s blood on a test cassette.
Under the agreement, First Light Biosciences also will conduct studies necessary to apply for Food and Drug Administration (FDA) approval.
The new test is part of BARDA’s comprehensive integrated medical countermeasures 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. These threats include chemical, biological, radiological and nuclear (CBRN) agents, pandemic influenza and emerging infectious diseases.
SRI International’s development of a diagnostic ability to quickly detect biothreat pathogen infections will be based on studies necessary for initial biomarker development, identificationand characterization, as well as clinical sample analysis and evaluation.
The pathogen responsible for melioidosis, Burkholderia pseudomallei, is widely found in water and soil in many tropical and subtropical regions. Infections vary from mild disease to overwhelming septicemia with up to 90 percent fatality rate within 24 to 48 hours after symptom onset. The current public health response to melioidosis infection is testing by cell culture with test results available no earlier than two to three days after sampling. Identification of biomarkers specific to infection can significantly accelerate the development of diagnostic assays with faster test results.
The development of clinically useful panels of blood-based biomarkers is 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.