Clinical TrialJul 21, 2026, 06:33 AM
Bluejay Diagnostics Completes Enrollment for SYMON-II Clinical Study
AI Summary
Bluejay Diagnostics announced the successful and early completion of patient enrollment for its SYMON-II multicenter clinical validation study. The study enrolled 750 patients to evaluate the Symphony™ IL-6 test's ability to assess 28-day all-cause mortality risk in sepsis patients. This milestone provides a robust clinical dataset, with a preliminary 17% 28-day mortality rate, which is crucial for future regulatory submissions and commercialization efforts. The company expects to complete data analysis and reporting in the coming months.
Key Highlights
- SYMON-II multicenter clinical validation study enrollment completed.
- Target enrollment of 750 patients achieved ahead of original schedule.
- Study evaluates Symphony™ IL-6 test for early sepsis mortality risk.
- Preliminary 28-day mortality rate of 17% observed in enrolled patients.
- Data cleaning, statistical analysis, and reporting expected in coming months.
- Results will support planned regulatory strategy and 510(k) application.
- Study provides one of the largest prospective datasets for IL-6 in sepsis.
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