Bluejay Diagnostics Announces SYMON-II Clinical Dataset Details Supporting Evaluation of Mortality Risk in Sepsis and Septic Shock
Key Highlights
- ➤SYMON-II includes 777 evaluable patients and 140 28-day non-survivors
- ➤Study population’s overall 28-day mortality rate was approximately 18%
- ➤39.5% of patients met Sepsis-3 criteria for septic shock
- ➤SYMON-II is intended to support a future FDA 510(k) application
- ➤Symphony IL-6 Test lacks FDA clearance and commercial U.S. availability
Expert Statements
Mark Feinberg, Chief Medical Advisor of Bluejay Diagnostics
“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,”
Mark Feinberg, Chief Medical Advisor of Bluejay Diagnostics
“The SYMON-II clinical validation study provides a substantial number of 28-day mortality events across patients with differing levels of sepsis severity, creating an important clinical foundation for evaluating the prognostic performance of IL-6.”
Mark Feinberg, Chief Medical Advisor of Bluejay Diagnostics
“The company's earlier SYMON-I pilot study provided an encouraging clinical signal supporting the potential role of IL-6 in mortality risk assessment,”
Mark Feinberg, Chief Medical Advisor of Bluejay Diagnostics
“The SYMON-II clinical validation study gives us the opportunity to evaluate that signal in a substantially larger and clinically diverse population.”
ACTON, MA / ACCESS Newswire / October 6, 2026 / Bluejay Diagnostics, Inc. (NASDAQ:BJDX) ("Bluejay" or the "Company"), a medical diagnostics company focused on improving patient outcomes through its Symphony™ near-patient diagnostic platform, today announced baseline clinical characteristics from the SYMON-II clinical validation study, highlighting a substantial and diverse population of critically ill patients and clinically meaningful mortality events for evaluating interleukin-6 ("IL-6") as a biomarker associated with 28-day mortality risk in patients with sepsis and septic shock. The current preliminary SYMON-II analysis includes 777 evaluable patients, consisting of 637 28-day survivors and 140 28-day non-survivors, representing an overall 28-day mortality rate of approximately 18%. The study population included patients across a broad spectrum of illness severity, ethnicity and geographical distribution with 39.5% meeting Sepsis-3 criteria for septic shock.
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