Beckman Coulter Achieves CE Mark for Its Early Sepsis Indicator*
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.
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