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.
“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.
“We are thrilled to receive this funding from BARDA, which will enable us to advance our HostDx Fever test into the clinic where it will help physicians quickly diagnose infections so they can get the right treatments to the right patients. This ability is key to combatting antibiotic resistance, which is one of the most pressing public health challenges of our time,” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix. “Through this public-private sector partnership, we will move precision medicine to the point of care, where it can have an immediate impact on patient outcomes.”
