Beckman Coulter Files a 510(k) Submission with the FDA for its Early Sepsis Indicator

Beckman Coulter has announced that it has filed a submission for 510(k) clearance with the U.S. Food and Drug Administration (FDA) for its Early Sepsis Indicator. The first-of-its-kind hematology-based solution is designed to give clinicians insight into the possibility of sepsis or risk of developing sepsis in patients in acute-care settings. The Early Sepsis Indicator is offered as part of a standard CBC with differential test. As such, test results can be available in less than one hour without additional workflow burden for clinicians or clinical laboratories. The Early Sepsis Indicator, which recently achieved European CE Mark, is commercially available in select countries for use with the company’s newly released DxH 900 hematology analyzer.

Sepsis is a global healthcare crisis, affecting 26 million people worldwide every year and increasing at a rate of 1.5% annually. Sepsis not only significantly affects patients and their loved ones, but also it places considerable clinical and economic burden on the healthcare system at large. The availability of timely, accurate detection solutions in the emergency department where treatment can be initiated, is critical to stopping the progression of this life-threatening condition. Patients with less severe sepsis can progress to severe sepsis or septic shock within 72 hours, and up to half of patients with sepsis die. A clear link exists between the timeliness of treatment and mortality.

“We want to give clinicians in the emergency department a simple tool to help them identify sepsis quickly, shortening time to treatment for these critical patients,” said Peter Soltani, Ph.D., senior vice president and general manager of the hematology business at Beckman Coulter. “Getting actionable clinical information to emergency department physicians sooner can speed critical treatment decisions.”

The Early Sepsis Indicator uses the DxH 900 hematology analyzer’s enhanced Coulter technology, which offers near native-state cellular characterization. The company’s powerful VCS 360 technology can uniquely detect morphological changes in monocytes, cells that play a role in the dysregulated immune response to sepsis. Identifying these monocyte morphological changes provides insight into possible sepsis earlier than other indicators.

Click here to visit our Clinical Diagnostics Community >>