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Bluejay Diagnostics has completed patient enrollment in its pivotal SYMON-II multicenter clinical validation study, reaching its target of 750 patients ahead of schedule.
The prospective study is evaluating the company's investigational Symphony™ IL-6 rapid diagnostic test, which is designed to help clinicians assess 28-day mortality risk in sepsis patients admitted, or expected to be admitted, to intensive care.
According to Bluejay, the enrolled population showed an approximately 17% 28-day mortality rate, providing a robust dataset to evaluate the prognostic value of IL-6 as an early sepsis biomarker.
The company will now begin data cleaning, statistical analysis, and clinical reporting, with the results expected to support future regulatory submissions and commercialization of the Symphony™ platform.
Neil Dey, President and CEO of Bluejay Diagnostics, said:
"Successfully completing enrollment ahead of schedule is an important operational achievement. We believe this study represents an important step toward bringing clinicians a rapid, near-patient tool capable of supporting earlier and more informed clinical decision-making."
The milestone advances Bluejay's regulatory strategy for the investigational Symphony™ platform, which is designed to deliver rapid bedside biomarker testing for critical care settings.
