To advance the development of a test that may be able to diagnose sepsis in less than 10 minutes, the U.S. Department of Health and Human Services (HHS) will partner with Cytovale of San Francisco.

Image/Sepsis Alliance

Under the cost-sharing agreement, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will provide expertise and $3.4 million to develop design specifications for the system. If successful, BARDA could provide an additional $4.17 million over 2.5 years for additional work, including studies needed to pursue regulatory clearance through the U.S. Food and Drug Administration (FDA).

Cytovale’s system incorporates the latest developments in microfluidics, high-speed imaging, and machine learning to identify sepsis-specific biophysical signatures of immune cells from a small volume of blood. Currently, doctors must rely on measuring patients’ vital signs, blood lactate levels and other clinical chemistry to identify sepsis; instead, Cytovale’s system looks at biophysical properties of immune cells and measures the immune cell activity associated with body’s immune response.

“We need faster diagnostics to reduce the health burden of sepsis in our country and save lives,” said BARDA Director, Rick Bright, Ph.D. “Like so many threats, speed of diagnosis is critical to improving outcomes for sepsis patients. Through this and other projects, our Solving Sepsis program continues to focus on catalyzing technology to address sepsis.”

Sepsis is a serious public health threat, killing approximately 270,000 Americans each year according to the Centers for Disease Control and Prevention. The condition is the result of a dysregulated immune response to infection, which causes serious tissue damage that may lead to organ failure and death. Sepsis could pose an even greater health security threat in a chemical, biological, radiological or nuclear emergency, or as a complication of an influenza pandemic or other emerging infectious disease outbreak.

The cost-sharing agreement announced today builds on work completed under a previous cost-sharing contract between Cytovale and BARDA’s Division of Research Innovation and Ventures (DRIVe). BARDA provided $749,000 under that agreement through an EZ-BAA, or easy broad agency announcement.

The BARDA DRIVe Solving Sepsis program is supporting development of several technologies that aim to increase our nation’s ability to respond to sepsis, including advanced development of sepsis diagnostics. DRIVe is also working closely with federal partners to address sepsis at every stage of patient care. These efforts are part of the HHS commitment to fully address sepsis as a medical emergency and potential disaster threat.