Bluejay Diagnostics Announces Baseline Clinical Data from SYMON-II Sepsis Study

Bluejay Diagnostics announced baseline clinical characteristics from its SYMON-II clinical validation study for the Symphony™ IL-6 Test, which is being developed to evaluate 28-day mortality risk in patients with sepsis and septic shock. The company stated this dataset represents a key milestone as it advances the diagnostic test toward a planned regulatory submission to the U.S. Food and Drug Administration (FDA).

Key Details

• Study Population: The preliminary analysis includes 777 evaluable patients, comprising 637 survivors and 140 non-survivors, resulting in an overall 28-day mortality rate of approximately 18%.
• Patient Severity: The data shows a critically ill population, with 39.5% of patients meeting Sepsis-3 criteria for septic shock. Septic shock was present in 56.4% of non-survivors compared to 35.8% of survivors.
• Regulatory Path: The SYMON-II study is the pivotal study the company plans to use to support a 510(k) application to the FDA for its Symphony™ IL-6 Test, which is not yet cleared or approved for commercial use.