AMBIGUOUS RESULTS

Bluejay reports 17% mortality rate as SYMON-II enrollment completes, no efficacy data yet

The 750-patient sepsis study finished enrollment and disclosed a baseline mortality rate, but Bluejay has not yet reported whether its Symphony IL-6 test actually predicts which patients die.

Bluejay Diagnostics completed enrollment of 750 patients in SYMON-II and disclosed a preliminary 28-day all-cause mortality rate of approximately 17% in the enrolled population.

By AppliedXLJuly 21, 2026Trial NCT06654895

Executive Summary

Bluejay Diagnostics finished enrolling its multicenter validation study of the Symphony IL-6 test in ICU sepsis patients, reaching its target population ahead of schedule.
The company reported a baseline 28-day mortality rate in the enrolled population, a description of how sick the study cohort is, not a measure of whether the test predicts that risk.
No sensitivity, specificity, or predictive-accuracy result for the IL-6 test itself was disclosed, leaving the core diagnostic-performance question unresolved even as enrollment closes.
The company has tied this study's results directly to a planned 510(k) submission, so the eventual performance readout, not the enrollment milestone, is what will determine regulatory viability.

The announcement

Bluejay Diagnostics, Inc. (NASDAQ: BJDX) said on July 21, 2026 that it completed patient enrollment in SYMON-II, a prospective, multicenter validation study of its Symphony IL-6 test in ICU sepsis patients, reaching its target of 750 patients earlier than the company had originally planned. The study, registered as NCT06654895, is designed to evaluate whether the IL-6 test can help clinicians assess 28-day all-cause mortality risk at admission. The company reported a preliminary observation that approximately 17% of the enrolled population experienced 28-day all-cause mortality, which it characterized as a clinically meaningful event rate for evaluating the test's prognostic utility. Bluejay+1

What the number does and doesn't show

A 17% mortality rate describes how sick the enrolled cohort was, the base rate the test would need to stratify, not evidence that the Symphony IL-6 test actually separated higher-risk from lower-risk patients. Bluejay's own release frames the figure as "a clinical dataset for evaluating the prognostic utility of IL-6," language about future analysis rather than a report of completed diagnostic performance. The company said it expects to complete data cleaning, statistical analysis, and clinical reporting over the coming months, meaning the sensitivity, specificity, or risk-stratification result the trial exists to produce had not been reported as of this disclosure. Bluejay

The regulatory line

Bluejay has tied SYMON-II directly to its regulatory plan, stating that results from the study, together with its predecessor SYMON-I, are expected to support a 510(k) submission, with regulatory pathway records showing a target submission window in 2027. Dr. Mark Feinberg, the company's Chief Medical Advisor, said the study's "large, well-characterized patient population and number of mortality events are expected to provide a foundation for assessing the prognostic performance of IL-6," a forward-looking characterization of what the completed dataset is expected to support, not a statement that the performance analysis is finished. No designation events tied to this program were found, which is unremarkable for a diagnostic device rather than a therapeutic. Bluejay

Operational picture

The trial's registry history shows no protocol amendments and a stable change profile, and enrollment closed at its full target of 750 patients ahead of the company's original timeline. Those are the routine markers of a device validation study that ran on schedule; they say nothing about the analytic result still pending. The company's own safety and efficacy disclosures for the Symphony IL-6 test were not reported in this release, consistent with a study still in its data-cleaning phase rather than one that has finished formal analysis. NCT06654895+1

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.