Bluejay Diagnostics completes enrollment in sepsis IL-6 study

Bluejay Diagnostics, Inc. (NASDAQ: BJDX) announced the completion of patient enrollment in its SYMON-II multicenter clinical validation study, reaching its target of 750 patients ahead of schedule, according to a company statement.

The prospective study is designed to evaluate the ability of Bluejay's Symphony IL-6 test to assist clinicians in assessing 28-day all-cause mortality risk in sepsis patients admitted or intended for admission to the intensive care unit. Patients were enrolled across multiple U.S. healthcare institutions.

Preliminary observations from the enrolled population show an approximately 17% 28-day mortality rate. The company said the dataset is intended to support analysis of whether clinical evidence warrants future regulatory submissions.

SYMON-II is the pivotal study the company plans to use to support a 510(k) application to the U.S. Food and Drug Administration. The Symphony platform remains an investigational device and has not received FDA clearance for commercial use.

"Successfully completing enrollment ahead of schedule is an important operational achievement," said Neil Dey, President and Chief Executive Officer of Bluejay Diagnostics. "The enrollment of 750 patients provides one of the largest prospective datasets focused on the role of IL-6 in early sepsis mortality risk assessment."

Bluejay said it expects to complete data cleaning, statistical analysis, and clinical reporting over the coming months. The Symphony platform is designed to deliver quantitative biomarker results at or near the patient's bedside in approximately 20 minutes.

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