Bluejay Diagnostics (NASDAQ:BJDX), a medical technology firm specializing in rapid near-patient testing, announced on April 7, 2026, that it has successfully enrolled 624 patients in its pivotal SYMON-II clinical trial.
The study is evaluating the Symphony™ IL-6 platform as a tool for the triage and monitoring of patients with sepsis.
The enrollment milestone represents more than 80% of the study’s total target of 750 patients.
Based on current site activity and patient flow, the company expects to complete the remaining enrollment within the next two to three months.
Management noted that the trial’s inclusion and exclusion criteria have not materially limited the recruitment pace, which has accelerated since the company reported 545 enrollees in mid-February.
The SYMON-II study is a multicenter validation trial designed to confirm the prognostic value of interleukin-6 (IL-6) levels in predicting mortality and organ dysfunction in critically ill patients.
Bluejay intends to use the resulting data to support a 510(k) submission to the U.S. Food and Drug Administration (FDA) for the Symphony IL-6 test.
Sepsis remains a leading cause of hospital mortality, and early intervention is often hampered by the lack of rapid, reliable biomarkers.
The Symphony platform aims to address this gap by providing accurate, laboratory-grade results at the point of care, allowing for faster clinical decision-making.