Addressing Sepsis across all of BARDA

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BARDA’s Response to Sepsis

BARDA aims to reduce the incidence, morbidity, mortality and cost of sepsis

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BARDA, ASPR and Sepsis Alliance have partnered to support the Infection Management/Sepsis Collaborative Community to accelerate innovation in the medical device ecosystem

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  • Sepsis can arise from almost any infection. Therefore, in order to be fully prepared against any threat, we need to address sepsis.
  • BARDA is leading development of innovative solutions to reduce the burden of sepsis by addressing the patient continuum of care.
  • Solving Sepsis Together requires all of government, industry and non-governmental organizations (NGOs).
  • Severe COVID-19 can become sepsis. BARDA has pivoted some of our sepsis approaches and MCM development to support our COVID-19 response.
  • We are building resilience in our preparedness posture through development of host targeted MCMs that empower patients and healthcare providers.
BARDA Programs

BARDA is investing across our portfolio to address sepsis

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CBRN Sepsis

ContraFect: Develop Exebacase, a first in class recombinantly produced lysin (cell wall hydrolase enzyme) for the treatment of Staphylococcus aureus bacteremia, including methicillin-resistant Staphylococcus aureus (MRSA), a major cause of sepsis. Exebacase has been granted Breakthrough Therapy and Fast Track designations by the FDA.

CARB-X is refueling the pipeline with novel antimicrobials and diagnostics that may also address sepsis that can arise from severe infection

  • Accelerate Diagnostics: a rapid optical imaging diagnostic for sepsis and serious antibiotic-resistant bacterial infections
  • Baebies Inc:  a rapid diagnostic for neonatal sepsis
  • UK-biotech GenomeKey: a rapid genomics-based diagnostic for sepsis, a leading cause of death in hospitals
  • Cellics: an innovative nanosponge that soaks up and neutralizes bacterial toxins and inflammatory cytokins that can cause sepsis

Roche Elecsys®  IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL-6 (interleukin-6) in human serum or plasma. This assay is used in countries accepting CE-mark to aid in the management of critically ill patients, as an early indicator for acute inflammation.
IL-6 could potentially be a marker for the detection of neonatal sepsis, the collaboration is aimed at getting FDA-approval for this indication.



Inflammatix is developing a point of care test that evaluates host-response gene expression patterns to identify whether a suspected infection is bacterial or viral, enabling physicians to quickly and accurately determine when to prescribe antibiotics. Using the same host-response gene analysis, future development may include a test that will rapidly diagnose infections in patients that are likely to have or develop sepsis.



Infection Severity Diagnostics

  • Beckman Coulter: Validation of its existing FDA cleared Monocyte Distribution Width (MDW) hematology-based biomarker with a machine-learning based sepsis diagnostic and prediction algorithm
  • Immunexpress: SeptiCyte uses host response gene expression, blood-based diagnostic for rapid identification of sepsis and triage of COVID-19 patients for severe outcomes (sepsis) in the ICU and ED.
  • Cytovale:  Rapid sepsis diagnostic that leverages advancement in microfluidics, ultra-high-speed imaging, and machine learning to rapidly quantify immune cell dysregulation from a blood sample in minutes to predict the likelihood of sepsis.
  • Qvella:  Expansion of FAST-ID platform to include host biomarkers for diagnosis of sepsis and infection
  • Inflammatix:  Host-response-based diagnostic to assess patients suspected of sepsis, separately determining presence of an infection as bacterial or viral and 30-day risk stratifying, to predict sepsis outcome

Host Based Therapeutics

  • Sentien:  Evaluation of cell-based therapeutic platform in people with sepsis, initially focusing on those with acute kidney injuries associated with sepsis (sepsis-AKI), including from COVID-19.
  • Bioaegis:  Expand development of novel human protein therapy to reduce disease severity in patients with severe infection and sepsis

Education Awareness

Responding to COVID-19

BARDA continues to support host-based medical countermeasures that can augment traditional pathogen-based approaches to aid in triage and management of COVID-19 patients. As severe COVID-19 disease may progress to sepsis, earlier identification, and intervention along the continuum of care could improve patient outcomes.


As part of our COVID-19 response, Rapidly Deployable Capabilities, was launched to empower patients, healthcare providers and aid in triaging patients for care or aid in allocation of resources. Many of these investments leveraged technologies that were developed for sepsis or could also be used in monitoring sepsis patients.

Rapidly Deployable Capabilities portfolio
Read more about what BARDA experts had to say about sepsis and COVID-19 on the ASPR Blogs
Read more about how applying lessons learned from COVID-19 therapeutic trials can improve future ALI/ARDS trials
Read more

Solving Sepsis Together

Working Across Government

Collaboration with US Government Agencies to Raise Sepsis Awareness

Working with NGOs

BARDA supports patient advocacy groups to develop educational content around sepsis.

Partnered with End Sepsis, The Legacy of Rory Staunton to raise awareness on maternal sepsis and identify those who may be at higher risk. See more here:

End Sepsis, The Legacy of Rory: Maternal Sepsis PSA

Partnered with Sepsis Alliance for the development of several webinars and training modules on an educational multiplatform focused on sepsis. See more here:

Sepsis Alliance Institute logo
*Note: Funding for this video was supported by BARDA as part of our educational content for maternal sepsis