Bluejay Diagnostics Announces Key Mortality Risk Data from SYMON-II Study
News related to:Bluejay Diagnostics · 1 min read
ACTON, Mass., October 6, 2026 /CourierPR/ -- Bluejay Diagnostics, a medical diagnostics company focused on improving patient outcomes, has announced key details from its SYMON-II clinical validation dataset. This dataset supports the evaluation of mortality risk in patients with sepsis and septic shock, using interleukin-6 (IL-6) as a biomarker.
The SYMON-II clinical validation study includes 777 evaluable patients, with 637 surviving 28 days and 140 not surviving. This translates to an overall 28-day mortality rate of approximately 18%. The study population is diverse, encompassing a broad spectrum of illness severity, ethnicity, and geographical distribution, with 39.5% of patients meeting Sepsis-3 criteria for septic shock.
The clinical characteristics of the study population highlight a significant disease burden. 84.0% of patients had bacterial infections reported, 32.4% had positive blood cultures, and infection was considered highly likely or likely in 86.5% of the study population. Notably, septic shock was present in 56.4% of non-survivors compared with 35.8% of survivors.
The SYMON Clinical Study Program includes SYMON-I (clinicaltrials.gov ID NCT06181604), SYMON-II (NCT06654895), and SYMON-III (NCT07425587). SYMON-I is a pilot study to determine IL-6 levels associated with various endpoints, including 28-day all-cause mortality and in-hospital mortality. SYMON-II is the pivotal study to validate the outcomes of SYMON-I, which the company plans to use to support a 510(k) application to the U.S. Food and Drug Administration (FDA).
Bluejay Diagnostics is developing the Symphony™ Suite as a rapid quantitative biomarker assay platform. The company's development strategy is intended to bring quantitative biomarker information closer to the patient and make results available rapidly enough to potentially complement clinical assessment and established measures of disease severity. The Symphony™ IL-6 Test is designed to provide accurate, reliable results in approximately 20 minutes from 'sample-to-result' to help medical professionals make earlier and better triage/treatment decisions.
The Symphony™ IL-6 Test has not been cleared or approved by the FDA and is not currently available for commercial clinical use in the United States. More information is available at www.bluejaydx.com.