Bluejay Diagnostics SYMON-II study has 777 patients, 18% 28-day mortality; supports IL-6 510(k) path

Bluejay Diagnostics, Inc.

Preliminary SYMON-II analysis includes 777 evaluable patients: 637 28-day survivors and 140 non-survivors, an overall 28-day mortality rate of about 18%.
39.5% of the study population met Sepsis-3 criteria for septic shock; septic shock present in 56.4% of non-survivors vs 35.8% of survivors.
84.0% of patients had bacterial infection, 32.4% had a positive blood culture, and infection was highly likely or likely in 86.5%.
SYMON-II is the pivotal study intended to support a 510(k) application to FDA for the Symphony IL-6 Test; the test is not cleared or approved and not commercially available in the U.S.
Bluejay continues analyzing IL-6 measurements versus 28-day mortality; baseline characteristics alone do not establish prognostic performance, clinical utility, sensitivity or specificity.

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