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Beckman Coulter Receives CE Mark for Routine Early Sepsis Indicator

NEW YORK (360Dx) – Beckman Coulter Diagnostics said on Wednesday that it has received CE marking for its Early Sepsis Indicator, a hematology test designed to alert emergency department clinicians to the risk of their patients developing sepsis.

The firm is offering the early sepsis indicator as part of a routine complete blood count with differential test. It gives physicians "a rapid and simple tool" that can aid in the fight against sepsis, Beckman said.

A complete blood count with differential measures the levels of red blood cells, white blood cells, platelet levels, hemoglobin, and hematocrit. Beckman noted that the early sepsis indicator is enabled by a new marker that will be commercially available on its recently launched DxH 900 hematology system, an analyzer for mid- to high-volume clinical laboratories.

Peter Soltani, senior vice president and general manager of the hematology business at Beckman Coulter, said in a statement that because the early warning indicator is part of a routine blood test, clinicians receive results rapidly and "with no additional workflow burden to the laboratory or emergency department.”

The indicator uses the DxH 900 hematology analyzer’s Coulter technology, which characterizes cells in their near-native states, Beckman said. The system detects morphological changes in monocytes — cells of the innate immune system that provide a first line of defense against infections and play a role in the dysregulated immune response to sepsis. Identifying morphological changes provides insight into possible sepsis earlier than other indicators, Beckman said.

Beckman noted that it soon plans to submit a 510(k) application for the early sepsis indicator to the US Food and Drug Administration, and intends to launch it on the US market pending FDA clearance.