aibioBluejay reports SYMON-II baseline patient characteristics
Tickers BJDX
The preliminary analysis covers 777 evaluable patients with an overall 28-day mortality rate of approximately 18%. The company says the baseline data do not yet establish the test's performance.
Key facts
- Company
- Bluejay Diagnostics, Inc. (NASDAQ: BJDX)
- News type
- Company Updates
- Primary source
- Bluejay Diagnostics, Inc. 8-K (2026-10-06)
On October 6, 2026, Bluejay Diagnostics, Inc. (NASDAQ: BJDX) released baseline clinical characteristics from its SYMON-II clinical validation study. The study is evaluating the Symphony IL-6 test as a biomarker associated with 28-day mortality risk in patients with sepsis and septic shock. The preliminary analysis includes 777 evaluable patients: 637 who survived 28 days and 140 who did not. That is an overall 28-day mortality rate of approximately 18%.
Who was enrolled
Bluejay says the study population spans a broad range of illness severity, ethnicity and geography. 39.5% of patients met Sepsis-3 criteria for septic shock. Bacterial infection was reported in 84.0% of patients, 32.4% had a positive blood culture, and infection was considered highly likely or likely in 86.5% of the population.
Patients who did not survive 28 days were more severely ill at baseline. Septic shock was present in 56.4% of non-survivors, compared with 35.8% of survivors.
Dr. Mark Feinberg, Chief Medical Advisor of Bluejay Diagnostics, said: "These clinical data are important because the value of a prognostic biomarker depends upon its evaluation in a sufficiently large and clinically relevant patient population with meaningful outcomes." He added that the study provides a substantial number of 28-day mortality events across patients with differing levels of sepsis severity. Feinberg also described the earlier SYMON-I pilot study as providing an encouraging clinical signal for IL-6 in mortality risk assessment.
What the data do not yet show
Bluejay states that the baseline characteristics do not, by themselves, establish the prognostic performance, clinical utility, sensitivity, specificity or regulatory acceptability of the Symphony IL-6 Test. Those conclusions depend on planned analyses. The company says it is continuing its analysis of clinical samples and data, including the relationship between IL-6 measurements and 28-day mortality and other clinical parameters. The release does not give a date for completing that work. It reports no IL-6 measurements at all, no sensitivity or specificity, and no comparison with existing measures of severity. The analysis is described as preliminary, and the release shows who was enrolled, not whether the test works. Non-survivors were sicker at baseline, so a test that tracks illness severity alone would not add much, and the release does not say how IL-6 adds to that.
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.
The release does not include financial results. Bluejay's XBRL financial data, drawn from its annual report filed March 6, 2026, shows a net income (loss) of negative $6.8 million for the fiscal year ended December 31, 2025, and research and development expense of $3.0 million for the same year. The same data shows cash used in operations of $6.1 million in 2025 and cash and cash equivalents of $9.6 million at June 30, 2026.
Why the baseline data matter
The release explains that sepsis is a highly heterogeneous and rapidly evolving condition, and that patients with severe infection can follow very different clinical courses. Bluejay says it is developing its Symphony Suite as a rapid quantitative biomarker assay platform, intended to make biomarker information available quickly enough to complement clinical assessment and established measures of disease severity.
Feinberg said the SYMON-II study gives the company an opportunity to evaluate the earlier SYMON-I signal in a substantially larger and clinically diverse population.
What comes next
The company plans to use SYMON-II, which it describes as the pivotal study, to validate the outcomes of SYMON-I and to support a 510(k) application to the FDA. SYMON-III is a pilot study of IL-6 levels in patients presenting to the emergency department with increasing severity of infection and risk of developing sepsis. Feinberg called the dataset an important clinical foundation for evaluating the prognostic performance of IL-6, and the company says its conclusions depend on completing the planned analyses.