FOR IMMEDIATE RELEASE July 18, 2019

Contact ASPR Press Office ASPRMedia@hhs.gov aspr.hhs.gov/newsroom Twitter:@ASPRgov

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.  

About HHS, ASPR and BARDA

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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Program advances next-generation technology to improve care for burn patients

An imaging device to evaluate the severity of burn injuries quickly and accurately will take the next steps in development under a contract by U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). Fast, accurate information about burn severity is critical to provide the appropriate care for patients.

This enhanced triage ability will be particularly important in any type of mass casualty incident involving burns, including those resulting from a nuclear detonation.

Triaging and treating burns effectively requires early clinical evaluations on the depth and severity of the injury. This initial clinical assessment informs a healthcare provider whether surgical procedures are necessary or if wounds will heal with other non-surgical treatment.

Under a 2-year, $27.3 million contract, SpectralMD, Inc., of Dallas, Texas, will advance the development of this next-generation burn imaging device, DeepView. The project is part of a long-standing effort by the Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR, to develop new medical products that help save lives during a radiological or nuclear emergency.

“We want to give medical providers as many modern tools as we can to help them save lives in disasters,” said BARDA Director Rick Bright, Ph.D. “An emergency situation with many burn casualties could overwhelm surgical facilities and specialized burn care providers. They need fast, accurate assessments of burn injuries to provide effective medical treatment and to guide appropriate use of limited burn care resources immediately.”

BARDA’s extensive market research has shown that burn surgeons consider current wound imaging technologies to be cumbersome and not user-friendly. Instead of using devices, experienced burn surgeons visually evaluate burn wounds and use their experience to determine the wounds’ healing potential.

However, this visual, clinical assessment requires experienced surgeons to be available, and the United States does not have enough experienced burn surgeons to evaluate the large number of burn patients anticipated in a radiological or nuclear incident.

Under a prior BARDA contract, SpectralMD demonstrated the potential of the DeepView technology in clinical study at a single burn center. This preliminary work demonstrated the potential of the DeepView technology to detect the burn depth at least as accurately as experienced burn surgeons.

The company is using advanced Artificial Intelligence (AI) algorithms to train the device’s software to analyze wounds at pixel level to determine tissue damage severity, burn depth and other physiological information well beyond human capability.

Under the new agreement with BARDA, SpectralMD will conduct an expanded feasibility clinical trial across five burn centers to further develop a new easily portable hardware platform and the machine learning algorithm for faster processing and optimal performance. The contract can be extended for up to a total of 4 years and up to $91.1 million. If extended, the contract would support algorithm training and validation (pivotal) studies as needed to seek FDA 510k clearance.

The device is part of BARDA’s robust portfolio of development projects to treat mass casualties from chemical, biological, radiological or nuclear incidents. These advanced development projects include eight products to treat skin injuries from burns and radiation, as well as other treatments for thermal burns, blast injuries and acute radiation exposure, such as blood, gastrointestinal, and lung injuries.

BARDA is seeking additional proposals for products that could be used to treat illnesses and injuries caused by disasters. Visit www.medicalcountermeasures.gov or Federal Business Opportunities (BARDA-CBRN-BAA-18-100-SOL-00003) to learn more about partnering with BARDA.

About HHS, ASPR and BARDA

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. For more about ASPR and BARDA, visit www.phe.gov.