Acton, Massachusetts, USA | July 21, 2026
Bluejay Diagnostics has announced the successful completion of patient enrollment in its SYMON-II multicenter clinical validation study, achieving the target of 750 patients ahead of schedule. The pivotal study is evaluating the performance of the company’s Symphony™ IL-6 rapid diagnostic platform for the early assessment of 28-day all-cause mortality risk in patients with sepsis who are admitted or expected to be admitted to the intensive care unit (ICU). Conducted across leading U.S. healthcare institutions, the study represents a major operational milestone in the development of Bluejay’s investigational near-patient diagnostic technology, which is designed to deliver quantitative IL-6 biomarker results in approximately 20 minutes. The clinical data generated from SYMON-II is expected to support future FDA 510(k) regulatory submissions and commercialization of the Symphony platform, strengthening the company’s position in the growing field of rapid critical care diagnostics.
Large Clinical Dataset Supports Early Sepsis Risk Stratification
The prospective multicenter SYMON-II study was designed to validate the clinical utility of interleukin-6 (IL-6) as an early prognostic biomarker for patients presenting with sepsis. Preliminary observations indicate an approximately 17% 28-day mortality rate among enrolled patients, providing a clinically meaningful dataset for evaluating the test’s ability to identify individuals at elevated risk of deterioration. According to Dr. Mark Feinberg, Chief Medical Advisor at Bluejay Diagnostics, rapid identification of high-risk sepsis patients remains one of the greatest challenges in emergency and intensive care medicine. If validated, the Symphony IL-6 test could enable clinicians to improve risk stratification, triage decisions, and treatment prioritization, allowing earlier therapeutic intervention for one of the world’s leading causes of hospital mortality.
Symphony Platform Designed for Rapid Bedside Decision Support
The investigational Symphony™ platform is engineered to provide rapid quantitative biomarker analysis directly at or near the patient’s bedside, supporting clinical decision-making in emergency departments, intensive care units, and other acute care environments. Unlike traditional laboratory testing, the platform is intended to integrate seamlessly into existing hospital workflows while significantly reducing the time required to obtain clinically actionable results. Beyond the initial IL-6 sepsis test, Bluejay plans to expand the platform to include additional biomarkers and future AI-enabled clinical decision support capabilities, creating a scalable diagnostic ecosystem for critical care. The company’s first product candidate remains investigational and has not yet received FDA regulatory clearance for commercial use in the United States.
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Enrollment Milestone Accelerates Regulatory and Commercial Strategy
According to Neil Dey, President and Chief Executive Officer of Bluejay Diagnostics, completing enrollment ahead of schedule reflects the commitment of clinical investigators, study coordinators, and the company’s research and development teams. The enrollment of 750 patients represents one of the largest prospective datasets evaluating IL-6 for early sepsis mortality risk assessment, providing a strong scientific foundation for regulatory evaluation. Over the coming months, Bluejay will complete data cleaning, statistical analysis, and clinical reporting, with the resulting evidence expected to play a central role in its planned FDA 510(k) submission for the Symphony IL-6 platform. The achievement also advances the broader SYMON Clinical Study Program, which includes SYMON-I, SYMON-II, and SYMON-III, reinforcing Bluejay’s strategy to deliver rapid, near-patient diagnostic technologies capable of improving clinical outcomes in time-critical conditions such as sepsis while strengthening its leadership in the evolving MedTech diagnostics market.
Source: Bluejay Diagnostics press release
