September 25, 2018
HHS partners to develop faster tests to identify bacterial infections
A test that may reduce, from days to hours, the time needed to diagnose patients with bacterial infections and determine how well an antibiotic will work against specific infections will receive advanced development support from the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).
The Biomedical Advanced Research and Development Authority (BARDA), part of ASPR, will sponsor the advanced development of the new testing technology under an 18-month, approximately $9.3 million contract with SeLux Diagnostic, Inc of Charlestown, Massachusetts.
SeLux is developing a phenotypic test; it identifies bacteria based on observable physical or biochemical characteristics of the bacteria. Based on the characteristics, the test identifies the class of bacteria and which antibiotics are best for treating that particular bacterial infection.
Faster information to select the best antibiotic can speed a patient’s recovery, which means fewer days spent in a hospital and better outcomes for patients. The ability to match bacteria more precisely to the drugs that will combat the infection also could curb antibiotic resistant infections.
“Antibiotic resistance is a growing threat to public health and to the health security of the United States,” said BARDA Director Rick Bright, Ph.D. “In a bioterrorism incident, antibiotic resistant infections could be devastating. We will need innovative tools for precision medicine to save lives.”
BARDA is sponsoring the development of two test systems from SeLux. The company’s first-generation test system may be able to provide results using bacteria isolated from patient samples 24 hours faster than current state-of-the-art methods and may be able to provide results from blood samples three days faster than the current methods. The company’s second-generation test system may be able to provide results the same day that the test is started.
The tests are designed to be used in hospital and commercial laboratories. Rapid information on bacteria and how susceptible they are to antibiotics would help doctors make earlier, better-informed decisions about how best to treat infections.
BARDA funding will support necessary work for the company to apply for U.S. Food and Drug Administration (FDA) approval. The agreement can be extended to fund additional work up to a total of approximately $36 million through 2023.
In addition to SeLux’s diagnostic test systems, BARDA is supporting development of other antibiotic susceptibility tests that can distinguish between bacterial and viral infections. BARDA also is working with federal partners to develop other tests that identify bacterial infections and the bacteria’s susceptibility to specific antibiotics. These efforts are part of the HHS commitment to combat antimicrobial resistance and to support antibiotic stewardship. To encourage antimicrobial stewardship further, ASPR provides hospitals and health care coalitions with guidance and the latest information on antibiotic resistant infections and new tools to combat them.
About HHS, ASPR and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.
Learn more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, visit the HHS public health emergency website.