Bluejay Diagnostics (NASDAQ: BJDX) announced it has successfully completed patient enrollment for its SYMON-II multicenter clinical validation study. The trial, which enrolled 750 patients ahead of schedule, is a pivotal step in developing the company's Symphony™ IL-6 rapid diagnostic test for assessing sepsis mortality risk.
Key Details
- Trial Objective: The SYMON-II study is designed to evaluate the Symphony™ IL-6 test's ability to help clinicians in the early assessment of 28-day all-cause mortality risk in patients with sepsis.
- Enrollment Milestone: The company achieved its target of 750 enrolled patients earlier than originally anticipated. Preliminary data indicates an approximate 17% 28-day mortality rate in the study population.
- Next Steps: Bluejay will now proceed with data cleaning, statistical analysis, and clinical reporting, with the results expected to form a critical part of its future regulatory submissions to the FDA for the Symphony™ platform.