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

Michael T McCurdy¹, Timothy E Sweeney², Debra Foster³, Bobby Reddy⁴, Steven Q Simpson⁵,

¹Division of Pulmonary and Critical Care Medicine, University of Maryland School of Medicine, Baltimore, MD.

²Inflammatix, Sunnyvale, CA.

³Spectral Medical, Toronto, ON.

⁴Prenosis, Chicago, IL.

⁵Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kansas, Kansas City, KS.

PubMed PMC DOI PDF

Abstract

OBJECTIVES: To characterize regulatory and clinical adoption challenges to developing host-based sepsis diagnostics and to establish a common framework for stakeholders to work together toward potential solutions to these challenges. DESIGN: Expert review, structured interviews, and small group discussions with experienced clinicians and experts in diagnostic test development and regulatory issue…

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