Lead Product Candidate in Clinical Trials
Bluejay Diagnostics’ first product candidate for Federal Drug Administration-approval is the Symphony™ IL-6 to test for sepsis. The IL-6 test cartridge used in concert with the Symphony Suite is projected to be submitted in 2027 for approval. Whether used in the hospital setting or long-term acute care, both have a significant estimated market opportunity, $925M and $2-3B respectively.
The IL-6 test is in the second of three clinical trial phases:
SYMON Clinical Study Program
(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, but not limited to 28-day all-cause mortality and in-hospital mortality
SYMON-II is the pivotal study to validate the outcomes of SYMON-I study, planned to be used to support a 510(k) application to the FDA. The study is in progress to support clinical validation, targeting 750 patients.
SYMON-III is a pilot study to determine IL-6 levels associated with patients presenting with increasing severity of infection in the emergency department and risk of developing sepsis.
Tentative Timeline
Clinical Advantage
- IL-6 on Day 0 showed promising prognostic performance for long-term (28-day) and short-term (7 day) mortality
- IL-6 on Day 0 improved risk prediction of mortality when added to specific SOFA Stratum
- IL-6 values are higher in non-survivors than survivors on Day 0 of hospital admission
- Evaluation of IL-6 on Day 0 holds promise in the management of patients with sepsis or septic shock
Strategic Advantage
- Competitive protection and intellectual property
- Comprehensive and regulatory-compliant data
- Reduced regulatory risk for future IL-6 diagnostic devices
- Validation pathway for IL-6 devices
In Research and Development
Symphony Cartridges for Cardiac Care
Bluejay is investigating other biomarkers that can be detected using the Symphony Suite to provide quicker diagnosis of conditions. Two additional cartridges are in research and development to determine patient acuity with chest pain. Use in hospitals for diagnosis of cardiac patients is an estimated $3.6 billion market.
Incorporating AI Predictive Modeling
Artificial intelligence has the capability to revolutionize the medical device industry by leveraging data to predict patient outcomes and guide intervention in real time. Bluejay is exploring the best way to integrate AI into IL-6 and future cartridges to transform Symphony into an intelligent clinical decision platform.
Learn More About Our First Product Candidate
Related Press Releases
Bluejay Diagnostics Announces Completion of Commercial-Scale IL-6 Antibody Production
SYMON-I Study of Symphony IL-6 Suggests Prediction of Mortality in Sepsis Patients