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This Study performs unique rapid on-site measurements of interleukin-6 (IL-6) and positions Company to move forward with multiple initiatives.
ACTON, Mass., Dec. 27, 2023 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ:BJDX) ("Bluejay" or the "Company"), today announced the initiation of a multicenter clinical study to evaluate the Symphony IL-6 test in sepsis patients (the SYMON study). The Symphony System is designed to address the need for simple, reliable, rapid, near-patient testing by providing quantitative measurements of specific biomarkers to determine the need for additional patient care and monitoring. The Symphony System was shown in published clinical studies to deliver results directly from whole blood in approximately 20 minutes.
"Sepsis is a leading cause of hospitalization and mortality, with about 1.7 million people developing sepsis in the US alone," said Dr. Mark Feinberg, Bluejay's Chief Medical Advisor. "Any new tests or tools that can help better guide management of this critical population could be impactful to the medical field."
This study will use the Symphony IL-6 test to monitor IL-6 concentrations in patients who are diagnosed with sepsis or septic shock and are admitted or intended to be admitted to the ICU. The objective of this study is to establish IL-6 concentrations in these sepsis patients that best predict 28-day mortality. The study design incorporates feedback from the pre-submission meetings with the FDA held earlier this year. The details of this clinical study are listed on clinicaltrials.gov (NCT06181604) and will be updated as more clinical study sites are brought into the study.
"We are very excited to start these important studies," said Neil Dey, Bluejay's Chief Executive Officer. "In addition to being one step closer to commercialization, these studies will help to identify potential competitive advantages of the Symphony IL-6."
About Interleukin-6
Interleukin-6 (IL-6) is an established biomarker of immune system activation. It is elevated in sepsis, infection, inflammation, and cancer. IL-6 presents in blood circulation as an early "first responder" in conditions which cause inflammation, such as sepsis, and needs to be measured quickly and reliably.
About the Symphony™System:
Bluejay's Symphony System (the "Symphony System") is designed to address the need for simple, reliable, rapid, near-patient testing by providing quantitative measurements of specific biomarkers to determine the need for additional patient care and monitoring. The user-friendly Symphony System will not require any sample preparation or dedicated staff and was shown in published clinical studies to deliver results in approximately 20 minutes.
The Symphony IL-6 Test is a development stage product candidate for investigational use only. It is limited by United States law to investigational use.
Posted In: BJDX
