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Beckman Coulter Receives Health Canada’s Medical Device License Approval for DxH 900 Hematology Analyzer and Early Sepsis Indicator*

Featuring innovative technology, these diagnostic tools will help enhance analysis and detection for critical blood-based conditions and diseases for patients across the country

 

Brea,Calif — (Sept. 24, 2018) — Beckman Coulter announced today that it recently received Health Canada’s Medical Device License approval for both its DxH 900 Hematology Analyzer and novel Early Sepsis Indicator. Offered as part of Beckman Coulter’s continued dedication to improving patient care in the area of hematology, these two diagnostic tools are designed to enhance a laboratory’s or institution’s ability to detect critical, potentially life-threatening, blood conditions and/or diseases like sepsis.

The DxH 900 Hematology Analyzer demonstrates industry-leading, 93 percent first-pass throughput,1 providing accurate flagging and reducing the number of slide reviews for mid- to high-volume clinical laboratories. This helps generate reportable results as quickly as possible, reducing the time, supplies, labor and costs that may be required for systems with higher repeat rates. Further, the analyzer features one of the smallest footprints in its class, making it highly efficient in utilization of laboratory space.

The parameters available with the DxH 900 Hematology Analyzer were developed to directly impact patient care by addressing critical conditions like thrombocytopenia, anemia and leukopenia. Sepsis is another often-deadly condition that affects 26 million people worldwide each year.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 and up to half of patients with sepsis die.4,5

Beckman Coulter’s new Early Sepsis Indicator uses the DxH 900’s enhanced technology to offer near native-state cellular characterization for early sepsis detection. This first-of-its-kind, hematology-based solution was created to give clinicians insight into the possibility of sepsis or risk of developing sepsis in adult patients in acute-care settings. Because Early Sepsis Indicator is reported together with the routine blood testing typically performed on emergency department admission, the results can be available in less than one hour. As a clear link exists between the timeliness of treatment and mortality,6 this early warning indicator enables clinicians to receive results rapidly, with no additional workflow burden to the laboratory or emergency department.

“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. “We remain dedicated to stopping the devastating effects of sepsis by giving emergency department clinicians the information they need to make important clinical decisions as quickly as possible.”

To further this initiative, Beckman Coulter continues to lead innovation in clinical diagnostics by investing in research and development in targeted areas to help ensure that sepsis will no longer be the 12th leading cause of death in Canada.7

About Beckman Coulter Diagnostics
Beckman Coulter Diagnostics helps healthcare and laboratory professionals provide better patient care by delivering the accurate diagnostic information they need, when they need it. With a rich 80-year history, Beckman Coulter is a strong partner 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.


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References:
1 DxH series side-by-side results documentation.
2 Sepsis Alliance. “Critical Fact Sheet.” Sepsis.org. Accessed January 15, 2018.
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 Angus DC, van der Poll T. “Severe Sepsis and Septic Shock.” N Engl J Med, vol. 369. 2013, pp. 840–51.
5 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.
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.
7 Canadian Sepsis Foundation. https://canadiansepsisfoundation.ca/. Accessed 8/15/2018.


*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 Hematology Analyzer is not available in all countries. The Early Sepsis Indicator is not available in all countries.


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