(RTTNews) – Bluejay Diagnostics, Inc. (BJDX) has successfully completed patient enrolment in its pivotal SYMON-II multicenter clinical validation study, reaching 750 patients ahead of schedule.
The study is designed to evaluate the Symphony IL-6 test for early assessment of 28-day mortality risk in patients with sepsis admitted or intended for admission to intensive care units (ICU).
Company Background
Bluejay Diagnostics is a medical diagnostics company focused on rapid, near-patient testing systems for critical care. Its Symphony platform is designed to deliver quantitative biomarker results in about 20 minutes, supporting clinical decision-making in emergency departments and intensive care units. The IL-6 test for sepsis is its lead product candidate.
Clinical Progress
SYMON-II enrolled patients across leading U.S. healthcare institutions, creating one of the largest prospective datasets focused on the role of IL-6 as a prognostic biomarker in sepsis. Preliminary observations indicate a mortality rate, providing a robust foundation for evaluating the test’s clinical utility.
Dr. Mark Feinberg, Chief Medical Advisor noted that sepsis remains a leading cause of hospital mortality worldwide, and emphasized the importance of high-risk patients. He stated that rapid IL-6 testing could improve risk stratification, triage decisions, and potentially enable earlier therapeutic interventions.
Operational Achievements
Neil Dey, President and Chief Executive Officer of Bluejay, highlighted that completing enrollment ahead of plan reflects the dedication of investigators and clinical teams. He added that the dataset will be critical for regulatory submissions and commercialization efforts of the Symphony platform.
Next Steps
Bluejay expects to complete data cleaning, statistical analysis, and clinical reporting in the coming months. Results from SYMON-II will form a key component of the company’s planned FDA 510(k) submission for the Symphony IL-6 platform.
BJDX has traded between $1.03 and $16.68 over the past year. The stock closed Monday’s trading at $1.21, down 16.55%. In pre-market trading the stock is at $1.17, down 3.28%.
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