Bluejay Diagnostics, Inc. (NASDAQ: BJDX) announced the baseline clinical characteristics from its SYMON-II clinical validation study on October 6, 2026. The study aims to evaluate interleukin-6 (IL-6) as a biomarker for 28-day mortality risk in patients with sepsis and septic shock.
The preliminary analysis includes 777 evaluable patients, comprising 637 survivors and 140 non-survivors. This group represents an overall 28-day mortality rate of approximately 18%. The study population is described as substantial and diverse, covering a broad spectrum of illness severity, ethnicity, and geography, with 39.5% meeting Sepsis-3 criteria for septic shock.
The data highlights the severity of the patient population. Of the participants, 84.0% had a reported bacterial infection, 32.4% had a positive blood culture, and infection was considered highly likely or likely in 86.5% of the group. The study also notes differences in baseline severity between survivors and non-survivors; specifically, 56.4% of non-survivors were diagnosed with septic shock compared to 35.8% of survivors.
Bluejay Diagnostics is developing the Symphony Suite as a rapid quantitative biomarker assay platform. The Symphony IL-6 Test is designed to provide results in approximately 20 minutes from sample-to-result. The company plans to use the SYMON-II study to support a 510(k) application to the U.S. Food and Drug Administration (FDA). The Symphony IL-6 Test has not yet been cleared or approved by the FDA and is not available for commercial use in the United States.
