Beckman Coulter Partners with Mass General and BARDA to Identify Severe Pediatric Infections in Emergency Departments

Rhea-AI Summary

On July 25, 2022, Beckman Coulter announced a partnership with Massachusetts General Hospital to validate the Monocyte Distribution Width (MDW) biomarker for identifying severe pediatric infections. Funded by BARDA, the multi-center trial focuses on children under 15 with high fevers, aiming to enhance early detection of those at risk for hospitalization. This initiative leverages MDW's existing FDA clearance for adult sepsis, expanding its clinical utility in emergency departments, potentially allowing for quicker, informed treatment decisions without unnecessary testing.

Positive

• Partnership with Massachusetts General Hospital enhances clinical research capabilities.
• Funding from BARDA supports the development of a novel pediatric diagnostic tool.
• MDW's existing FDA clearance for adult patients establishes a foundation for pediatric applications.

Negative

• None.

BREA, Calif., July 25, 2022 /PRNewswire/ -- Beckman Coulter, global leader in advanced diagnostics, today announced that it will partner with Massachusetts General Hospital to validate the use of the novel Monocyte Distribution Width (MDW) hematology biomarker in rapid identification of children presenting with early signs of severe illness from infection.

This pivotal, multi-center trial will receive funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. MDW is currently the only FDA-cleared blood biomarker to aid in detecting adult sepsis in the Emergency Department (ED). This current partnership aims to expand the utility of MDW as a screening tool to measure the severity of infection in children 15 years old and younger presenting with high fevers.

Approximately 25 million children under 15 visit the emergency room every year, and about one in five presents with a fever.¹ The most common cause of fever in these children is infections that can be safely treated at home; however, one out of every four pediatric hospital admissions are due to complications from infection.² No objective biomarker yet exists that accurately identifies children at risk of hospitalization from an excessive immune response early in the infectious course when intervention is critical, making clinical decisions in the ED on how to treat pediatric infections difficult.

"A sick, febrile child can be challenging to examine, and current blood tests have limited ability to predict who will progress to acute illness," states Lael Yonker, M.D., a pediatric pulmonologist at Mass General for Children, and co-investigator on this clinical trial.  "Objective tests that are readily available are needed to make sure children get the medical attention they need in a timely manner."

The utility of MDW as a biomarker in pediatric infection was first recognized by Mass General during the height of the COVID-19 pandemic, when more than 400 children a month were developing a life-threatening complication from COVID-19, now termed Multisystem Inflammatory Syndrome in Children (MIS-C).

As published in June 2022 in BMC Infectious Diseases³, the team found that MDW can improve the identification of children at high risk of MIS-C complication, a task that has proven challenging to clinicians.⁴ Now, this team will join Beckman Coulter and BARDA to potentially expand the use of MDW in the early recognition of severe infections in children presenting to EDs.

Notably, this tool is based on routinely ordered blood tests and can be reported as an additional parameter on Complete Blood Count (CBC) results. This approach may allow ED physicians to make rapid, accurate and safe decisions about which children with infections can go home and which children with infections need to be admitted to the hospital for further treatment without subjecting patients to additional and costly testing. 

"We are thrilled to be partnering with pediatricians at Mass General to investigate the utility of MDW in identifying children at risk of adverse outcomes due to infection," said Julie Sawyer Montgomery, president, Beckman Coulter. "Along with the award from BARDA, Beckman Coulter is committing additional funds to this partnership. We are invested in establishing the performance of MDW in the pediatric population and in continuing our commitment to clinical evidence for use of MDW, and other novel hematological biomarkers."

MDW is a regulatory-cleared parameter for adult patients presenting to the ED and is available as a standard component of a CBC performed on Beckman Coulter's DxH 900 and 690T hematology analyzers. The MDW parameter measures the dispersion of monocyte volume in the blood, which is altered during infection due to monocyte activation and subsequent changes in monocyte morphology. Increases in MDW indicate increases in the variability of monocyte morphology, which can indicate a progression from localized to systemic infection.

MDW provides physicians with an early indication of sepsis risk, which is especially important when a patient's symptoms are mild and alternative diagnoses are being considered. MDW is only available on Beckman Coulter platforms.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50122C00036.

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About Beckman Coulter. Inc.

A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 80 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what's now to what's next. We do this by accelerating care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimize lab performance services. Beckman Coulter is part of the Danaher Corporation (NYSE:DHR) family of global science and technology companies. Headquartered in Brea, Calif., it has more than 11,000 global team members.

1. Cairns C, Kang K, Santo L. National Hospital Ambulatory Medical Care Survey: 2018 emergency department summary tables. Available from: FastStats - Emergency Department Visits (cdc.gov)
2. Goto T, Tsugawa Y, Mansbach JM, Camargo CA Jr, Hasegawa K. Trends in Infectious Disease Hospitalizations in US Children, 2000 to 2012. Pediatr Infect Dis J. 2016;35(6):e158-e163. doi:10.1097/INF.0000000000001134
3. Yonker LM, Badaki-Makun O, Arya P, Boribong BP, Moraru G, Fenner B, Rincon J, Hopke A, Rogers B, Hinson J, Fasano A, Lee L, Kehoe SM, Larson SD, Chavez H, Levin S, Moldawer LL, Irimia D. Monocyte anisocytosis increases during multisystem inflammatory syndrome in children with cardiovascular complications. BMC Infect Dis. 2022;22(1):563. doi: 10.1186/s12879-022-07526-9.
4. Rosu CA, Martens AM, Sumner J, Farkas EJ, Arya P, Arauz AB, Madhavan VL, Chavez H, Larson SD, Badaki-Makun O, Irimia D, Yonker LM. Heterogeneity in the evaluation of suspected MIS-C: a cross-sectional vignette-based survey. BMC Pediatr. 2022;22(1):392. doi: 10.1186/s12887-022-03446-4.

© 2022 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. 2022-10652

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FAQ

What is the Monocyte Distribution Width (MDW) biomarker used for in children?

MDW is used for the rapid identification of children showing early signs of severe infections.

Who is funding the MDW validation trial for children?

The trial is funded by the Biomedical Advanced Research and Development Authority (BARDA).

What age group does the MDW trial focus on?

The trial focuses on children aged 15 years and younger.

What company is associated with the MDW biomarker and validation trial?

The company is Beckman Coulter, part of Danaher Corporation (NYSE:DHR).

When was the partnership between Beckman Coulter and Massachusetts General Hospital announced?

The partnership was announced on July 25, 2022.