Challenges Facing Developers of Diagnostic Tests for Sepsis: A Report From Sepsis Alliance and the Infection Management and Sepsis Collaborative Community

A collaborative statement was created outlining the challenges of developing diagnostic tests and devices for sepsis, including existing regulatory requirements surrounding host-based sepsis diagnostics and their implications for ultimate clinical deployment. Characterizing these challenges is a necessary first step to establish a common framework for stakeholders to effectively engage in discussions to develop potential solutions.