Support for Diagnostics Technology

HHS is supporting the development of a novel diagnostics technology to read gene expression patterns in the immune system capable of distinguishing bacterial infections from viral infections.

The HHS Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response, is advancing host-response testing under a 14 month $6 million contract with Inflammatix Inc. in Burlingame, California.

This agreement will provide BARDA financial and technical support for up to $64.9 million through 2027, for the company to complete the additional work needed to apply for FDA clearance for the tests.

Inflammatix is going to develop three diagnostic tests for use with a point-of-care test system with results expected within 20-30 minutes. Rapid information will be available on whether the infection is viral versus bacterial to help doctors make earlier and better informed decisions on whether to treat the infection with or without antibiotics.

The first Inflammatix test, called “HostDx Fever” will help distinguish bacterial from viral infections in outpatient ambulatory settings. The second test called “HostDx Sepsis” will be used in inpatient hospital settings and may determine whether a patient is likely to develop sepsis. The third test “HostDx FeverFlu” will be used in either setting during influenza season and combine rapid flu testing with host-response data.

According to BARDA Director Rick Bright, PhD, “Antimicrobial resistance is a growing threat to public health and the health of the U.S. Developing diagnostics technology that can provide rapid results to patients and doctors will support stewardship of antibiotics and save lives.”

In addition to the Inflammatix diagnostic test systems, BARDA with other federal partners supports the development of other diagnostic tests to identify bacterial pathogens and susceptibility to specific antibiotics, along with improving tests to identify the risk of a patient becoming septic.

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