First-of-its-kind hematology-based test intended to alert
emergency department clinicians to the possibility of sepsis or
risk of developing sepsis as part of a routine CBC with
differential test
BREA, California, May 3, 2018 /PRNewswire/ -- Beckman
Coulter announced today European CE Mark of its Early Sepsis
Indicator, a hematology-based solution designed to alert emergency
department clinicians to the possibility of sepsis or risk of
developing sepsis. The first early sepsis warning solution to be
offered as part of a routine CBC with differential test, the Early
Sepsis Indicator gives physicians a rapid and simple tool that can
aid in the fight against sepsis. The new marker will be
commercially available on the recently launched DxH 900 hematology
analyzer.
Sepsis is an often-deadly condition that affects 26 million
people worldwide every year1 and is increasing at a rate
of 1.5% annually.2 Timely and accurate detection
solutions in the acute-care setting are key components to stopping
the progression of sepsis, as patients with less severe sepsis can
progress to severe sepsis or septic shock within 72
hours.3 Up to half of patients with sepsis
die.2,4 In addition to the human toll, this global
crisis places a significant clinical and economic burden on the
healthcare system.5 A clear link exists between the
timeliness of treatment and the possibility of death. When
antibiotics are administered early to patients with septic shock,
the likelihood of death is decreased by 7.6% per
hour.6
"Because emergency department personnel are often on the front
line of care for people facing critical conditions, giving them a
simple and easy tool for detecting sepsis can help us make
significant strides against this prevailing threat," said
Peter Soltani, Ph.D., senior vice
president and general manager of the hematology business at Beckman
Coulter. "The fact that this early warning indicator is part of a
routine blood test means that clinicians receive results rapidly,
with no additional workflow burden to the laboratory or emergency
department."
The Early Sepsis Indicator uses the DxH 900 hematology
analyzer's unique Coulter technology, which characterizes cells in
their near-native states. The system's powerful VCS 360 technology
can uniquely detect morphological changes in monocytes—cells of the
innate immune system that provide a first line of defense against
infections. Monocytes play a role in the dysregulated immune
response to sepsis, and identifying morphological changes provides
insight into possible sepsis earlier than other indicators.
The company plans to submit a 510(k) for the Early Sepsis
Indicator to the U.S. FDA in the near future. After receiving
510(k) clearance, the Early Sepsis Indicator will be released to
the U.S. market.
About Beckman Coulter
Beckman Coulter Diagnostics helps healthcare and laboratory
professionals provide better patient care by delivering the
accurate diagnostic information they need, when they need it. For
over 80 years, Beckman Coulter has been the partner of choice for
healthcare organizations. Our scalable instruments, comprehensive
diagnostic tests and business management services are trusted by
hospitals, laboratories and other critical care settings around the
world. We share in our customers' mission toward continuous
improvement and quality patient care because we believe when
efficiency and clinical outcomes are improved, patients benefit and
we can move healthcare forward for every person.
1. Sepsis Alliance. "Critical Fact
Sheet." Sepsis.org. Accessed January 15,
2018.
2. Angus DC, van der Poll T. "Severe Sepsis
and Septic Shock." N Engl J Med, vol. 369. 2013,
pp. 840–51.
3. Glickman SW et al. "Disease Progression
in Hemodynamically Stable Patients Presenting to the Emergency
Department with Sepsis." Acad Emerg Med, vol. 17. 2010, pp.
383–90.
4. Engel C, Brunkhorst FM, Bone HG et al.
"Epidemiology of Sepsis in Germany: Results from a National Prospective
Multicenter Study." Intensive Care Med, vol. 33.
2007, pp. 606–18.
5. Torio C, Moore B. "National Inpatient
Hospital Costs: The Most Expensive Conditions by Payer."
http://www.hcup-us.ahrq.gov/reports/statbriefs/sb204-Most-Expensive-Hospital-Conditions.pdf,
May 2016. Accessed January 15, 2018.
6. Kumar A, Roberts D, Wood KE et al.
"Duration of Hypotension Before Initiation of Effective
Antimicrobial Therapy is the Critical Determinant of Survival in
Human Septic Shock." Crit Care Med, vol. 34. 2006, pp.
1589–96.
Disclaimer: The Early Sepsis Indicator is CE
Marked and is pending 510(k) clearance by the U.S. FDA. Not yet
available for in vitro diagnostic use in the U.S.
The DxH 900 analyzer is not available in all countries. The
Early Sepsis Indicator is not available in all countries.
© 2018 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.
Logo -
https://mma.prnewswire.com/media/525815/Beckman_Coulter_Logo.jpg