November 14, 2019
HHS Advances Development of Tests to Distinguish Bacterial from Viral Infections across Multiple Healthcare Settings
A novel diagnostics technology that reads gene expression patterns in the immune system to distinguish bacterial infections from viral infections and determines the severity within minutes will receive advanced development support from the U.S. Department of Health and Human Services (HHS). The technology is being designed for use in outpatient and inpatient healthcare settings.
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will support the advanced development of the new testing technology, known as host-response testing, under a 14-month, $6 million contract with Inflammatix Inc., of Burlingame, California.
This agreement can be extended to provide BARDA’s financial and technical support, up to a total of $64.9 million through 2027, for the company to complete the additional work needed to apply for U.S. Food and Drug Administration (FDA) clearance of the tests.
Inflammatix is developing three diagnostic tests for use on a point-of-care test system with results expected within 20-30 minutes. Rapid information on whether the infection is viral versus bacterial will help doctors make earlier, better-informed decisions about whether to treat the infection with or without antibiotics.
“Rapid diagnostics are a cornerstone of our strategy to protect Americans from many bacterial and viral infections; earlier diagnosis can empower patients to take action to reduce disease transmission,” said BARDA Director Rick Bright, Ph.D. “Antimicrobial resistance is a growing threat to public health and the health security of the United States, and diagnostics that can provide rapid results to patients and doctors will support stewardship of antibiotics and save lives.”
The first Inflammatix test, called HostDx Fever, is intended to help distinguish bacterial from viral infections in outpatient ambulatory settings; the second test, called HostDx Sepsis, is intended for inpatient hospital settings and also may determine whether a patient is likely to develop sepsis. The third test, HostDx FeverFlu, is intended for use in either setting during influenza season and combines rapid flu testing with host-response data.
In addition to the Inflammatix diagnostic test systems, BARDA, in collaboration with other federal partners, is supporting development of other diagnostic tests to identify bacterial pathogens and their susceptibility to specific antibiotics, along with improved tests to identify the risk of a patient becoming septic. These efforts are part of the HHS commitment to combat antimicrobial resistance and to support antibiotic stewardship.
To encourage antimicrobial stewardship further, ASPR also 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 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. To date, 52 BARDA-supported products have achieved regulatory approval, licensure or clearance. BARDA accepts proposals for the advanced development of medical countermeasures through the Broad Agency Announcement, BARDA-BAA-18-100-SOL-00003, at https://www.fbo.gov.
Learn more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, by visiting the HHS public health emergency website, www.phe.gov. For more information on partnering with BARDA on developing medical countermeasures, visit www.medicalcountermeasures.gov.