Public Health Emergency - Leading a Nation Prepared
With diagnostic tests based on machine-learning algorithms, patients with sepsis in hospital emergency departments, intensive care units and other hospital settings could be identified sooner than they currently are, and now the U.S. Department of Health and Human Services (HHS) will work with Beckman Coulter Diagnostics of Brea, California, to develop such tools.
To develop the machine-learning algorithm, the Biomedical Advanced Research and Development Authority’s (BARDA) Division of Research Innovation and Ventures (DRIVe), part of the HHS Office of the Assistant Secretary for Preparedness and Response, will provide an initial $1.25 million under a cost-sharing contract with Beckman Coulter.
BARDA DRIVe could provide an additional $6.5 million over four years under the cost-sharing agreement to support advanced research and development, validation and regulatory approval of the novel algorithm-based diagnostic. Beckman Coulter will work with Dascena Inc. of Oakland, California, to develop the algorithm.
“The ability to improve specificity of diagnostic tools for rapid detection of sepsis and expand this capability to all hospital units and the emergency department through use of electronic health record data and blood clinical chemistry will greatly change the field,” said BARDA Director Rick Bright, Ph.D. “With sepsis, every minute counts and is critical for a full recovery. We want to make sure we can identify sepsis in all patients as rapidly as possible.”
The digital diagnostic solution combines clinical data from laboratory tests and patient data from electronic health records in a predictive machine learning algorithm expected to more accurately detect sepsis early and improve patient outcomes compared to current clinical practice which relies primarily on monitoring the patient’s vital signs and blood lactate levels.
This solution builds on Beckman Coulter’s existing Early Sepsis Indicator, which received FDA 510K clearance in April 2019 and integration with Dascena’s InSight predictive algorithm for sepsis.
According to the Centers for Disease Control and Prevention, sepsis kills approximately 270,000 Americans each year. The condition results from a dysregulated immune response to infection and causes serious tissue damage that may lead to organ failure and death.
Sepsis represents a serious public health threat and could amplify many health security threats in a chemical, biological, radiological or nuclear emergency, or as a complication of influenza or other infectious diseases. Sepsis is difficult to diagnose due to the heterogeneity of the condition and the difficulty of predicting the progression from infection to sepsis.
This project is part of BARDA DRIVe’s Solving Sepsis program, which aims to reduce the incidence, morbidity, mortality and cost associated with sepsis by taking a systems approach in key strategic areas for sepsis, which includes developing diagnostics that address sepsis earlier along the patient continuum of care.
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 the Office of the Assistant Secretary for Preparedness and Response (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.
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