BREA, Calif., Oct. 15, 2020 /PRNewswire/ -- Beckman Coulter, a
global clinical diagnostics leader, today announced that it was
awarded funding by 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, for a multi-center clinical trial to validate
the ability of its Monocyte Distribution Width (MDW) hematology
biomarker to aid in the rapid detection of Multisystem Inflammatory
Syndrome in Children (MIS-C). Recently defined by the Centers for
Disease Control and Prevention (CDC), MIS-C is a rare but severe
complication seen in children following SARS-CoV-2 infection.
The BARDA award will help fund a collaborative effort between
Beckman Coulter and academic partners at Massachusetts General Hospital (MGH), Johns Hopkins University School of Medicine and the
University of Florida to validate the
effectiveness of the biomarker to detect MIS-C with a large,
multi-center clinical trial to support regulatory submissions.
Preliminary results from a study initiated at MGH earlier this year
revealed that MDW has the potential to aid in the rapid detection
of MIS-C. An abnormal MDW could potentially aid in triaging
patients for care, starting treatment early and determining patient
disposition.
"Primary care doctors and emergency department physicians need a
rapid, reliable diagnostic test for MIS-C to accurately identify
children early in the illness," said Lael
Yonker, M.D., pediatric pulmonologist at MGH, assistant
professor at Harvard Medical School and
one of the lead researchers on the study. "Fevers are very common
in kids, but most are caused by self-limiting infections or they
resolve with antibiotics. MIS-C also presents with fever, but it
can progress to a severe, life-threatening illness."
Initially reported as hyperinflammatory shock and "Kawasaki-like" illness, MIS-C has been
observed to have overlapping features with toxic shock syndrome,
atypical Kawasaki disease,
macrophage activation syndrome, and cardiogenic and septic shock.
Although most MIS-C patients survive with adequate intensive care,
deaths have been reported1,2. The long-term consequences
of MIS-C are currently unknown.
"Identifying MIS-C is challenging because the primary symptom is
one of the most common symptoms prompting pediatric evaluation in
children of all ages," said Shamiram R.
Feinglass, M.D., M.P.H., chief medical officer, Beckman
Coulter. "Given the community spread of COVID-19, empowering
clinicians with a tool to aid in the early detection of MIS-C is
critical because, undetected, MIS-C can result in the rapid onset
of hypotensive shock, cardiac aneurysm or ventricular failure. The
MDW biomarker is unique because it is available as part of a
routine complete blood cell count. Having this specific data so
early in the encounter enables physicians to act fast when every
moment matters."
Beckman Coulter's MDW biomarker is a measure of increased
morphological variability of monocytes, which can biologically
indicate the presence of a systemic infection. The quantitative
analysis of MDW has received regulatory clearances as an aid for
early detection in adult patients with or developing sepsis in
emergency departments. Considered with other signs and symptoms,
the value of MDW helps differentiate sepsis from non-septic
presentations, including non-infectious, systemic inflammatory
response.
The research to explore MDW's utility in aiding in the rapid
detection of MIS-C is part of BARDA's Rapidly Deployable
Capabilities program to identify and pilot near-term innovative
solutions for COVID-19. For more information on Beckman Coulter's
MDW biomarker, visit www.BeckmanCoulter.com/sepsis. For more
information on BARDA's rapidly-expanding COVID-19 medical
countermeasure portfolio, visit BARDA's COVID-19 Portfolio.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every
person by applying the power of science, technology and the passion
and creativity of our teams to enhance the diagnostic laboratory's
role in improving healthcare outcomes. Our diagnostic systems are
used in complex biomedical testing, and are found in hospitals,
reference laboratories and physician office settings around the
globe. Beckman Coulter offers a unique combination of people,
processes and solutions designed to elevate the performance of
clinical laboratories and healthcare networks. We do this by
accelerating care with a menu that matters, bringing the benefit of
automation to all, delivering greater insights through clinical
informatics and unlocking hidden value through performance
partnership. An operating company of Danaher Corporation (NYSE:
DHR) since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global
associates working diligently to make the world a healthier
place.
References:
1 Cheung, E. W. et al. Multisystem
Inflammatory Syndrome Related to COVID-19 in Previously Healthy
Children and Adolescents in New York
City. JAMA 324, 294-296, doi:10.1001/jama.2020.10374
(2020).
2 Feldstein, L. R. et al. Multisystem
Inflammatory Syndrome in U.S. Children and Adolescents. N Engl J
Med 383, 334-346, doi:10.1056/NEJMoa2021680 (2020).
© 2020 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.
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