Beckman Coulter-BARDA Partnership Expanded for Sepsis Diagnostic and Prediction Algorithm in COVID-19 Patients

(Oakland, CA, USA) for additional advanced research and development toward optimization of a machine-learning based sepsis diagnostic and prediction algorithm to include assessing its use with coronavirus (COVID-19) patients.

The sepsis diagnostic and prediction algorithm builds on Beckman Coulter's existing Early Sepsis Indicator, which received FDA 510(k) clearance in April 2019, combining the monocyte distribution width (MDW) novel laboratory test parameter values with Dascena's electronic health record data based machine-learning algorithm to help accurately predict and detect those with sepsis.

"Until recently, the majority of sepsis cases have been thought to be caused by bacterial pathogens," said Shamiram R. Feinglass, M.D., MPH, chief medical officer, Beckman Coulter. "COVID-19 is changing that, and causing a paradigm shift in how we think about sepsis. The aim of the study is to determine whether MDW, as part of the sepsis prediction algorithm, will be able to aid in the detection of sepsis regardless of whether it is bacterial or viral-induced."

The COVID-19 specific study is part of BARDA's Rapidly Deployable Capabilities program to identify and pilot near-term innovative solutions for COVID-19, leveraging the development of Beckman Coulter's digital sepsis prediction algorithm under BARDA's Division of Research Innovation and Venture's (DRIVe's) Solving Sepsis Program.

"The global impact that COVID-19 has had on the health system is undeniable. It has changed the way the industry thinks about so many things, and sepsis is no exception," said Peter Soltani, Ph.D., senior vice president and general manager of the hematology business unit at Beckman Coulter. "Beckman Coulter is deeply committed to the fight against COVID-19 and has been working diligently to quickly bring quality SARS-CoV-2 serology assays to the market. We are thrilled to expand our partnership with BARDA, so we can extend that commitment to our sepsis research and begin clinical trials that include COVID-19 patients."