Diagnostic Tests for Sepsis

According to CDC, sepsis kills about 270,000 Americans each year. The condition results from an immune system response to infection which can cause serious tissue damage that may lead to organ failure and death.

Patients with sepsis in hospital emergency department, intensive care units and other hospital settings could be identified sooner if doctors were able to use diagnostic tests based on machine-learning algorithms. To accomplish this goal, HHS is going to work with Beckman Coulter Diagnostics https://beckmancoulter.com of Brea California to develop the needed tools.

The Biomedical Advanced Research and Development Authority (BARDA)T https://www.phe.gov/about/barda within the Division of Research Innovation and Ventures (DRIVe), https://drive.hhs.gov and part of the HHS Office of the Assistant Secretary for Preparedness and Response https://www.phe.gov, is going to provide an initial $1.25 million for development  of the machine learning algorithm under a cost sharing contract with Beckman Coulter.

BARDA DRIVe may provide an additional $6.5 million over four years under the cost sharing agreement to support advanced research and development and validate regulatory approval of the novel algorithm-based diagnostic.

This project is part of BARDA DRIVe’s “Solving Sepsis” program which aims to reduce the incidence, mortality, and costs associated with sepsis by using a systems approach in key strategic areas for sepsis which includes developing diagnostics to address sepsis earlier while the patient is receiving care.

The digital diagnostic solution combines clinical data from laboratory tests along with patient data obtained from EHRs to develop a predictive machine-based detection algorithm. This is expected to accurately detect sepsis early and improve patient outcomes as compared to current clinical practices which rely primarily on monitoring the patient’s vital signs and blood lactate levels.

Beckman Coulter will work with Dascena Inc. of Oakland, California to develop the machine-based sepsis detection algorithm. This solution builds on Beckman Coulter’s existing early sepsis indicator, that received FDA 510K clearance in April 2010 and then was integrated with Dascena’s InSight predictive algorithm for sepsis.

“The ability to improve specificity of diagnostic tools for the rapid detection of sepsis and then expand this capability to all hospital units and the emergency department through the use of EHR data and blood clinical chemistry, will greatly change the field,” said BARDA Director Rick Bright PhD.

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