Bluejay Diagnostics Updates Symphony IL-6 Regulatory Strategy
Saturday, May 20, 2023
Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical technology company developing rapid diagnostics on its Symphony platform to improve patient outcomes in critical care settings, today announced an updated clinical and regulatory strategy for the Symphony IL-6 biomarker test to measure acuity in sepsis patients. The Company plans to modify the clinical trials design to evaluate Symphony IL-6 as a tool to risk stratify hospitalized sepsis patients.
Bluejay is adapting its clinical trial design to obtain more patient data, which aligns the regulatory strategy with recent FDA feedback. The trial previously included only severe COVID-19 patients, which have substantively declined since the trial initiated. The Company plans to amend the study to include hospitalized sepsis patients, expanding the inclusion to facilitate a rate of enrollment necessary to maintain the previously disclosed Symphony IL-6 regulatory submission timeline of the first half of 2024. The trial modification may also support an FDA regulatory submission with an initial indication for risk stratification of hospitalized sepsis patients. Bluejay plans to submit a pre-submission application to the FDA presenting the new study design during the second quarter of 2023.
“We believe that our updated clinical strategy puts us on the most efficient pathway to obtain regulatory clearance for Symphony IL-6,” said Neil Dey, CEO of Bluejay Diagnostics. “The new indication expedites clinical enrollment by broadening patient eligibility and provides expanded utility of Symphony. We are excited to demonstrate Symphony’s value and be closer to achieving our mission of improving patient outcomes in critical care settings.”
The Company believes that Symphony IL-6 has the potential to be an influential tool for the prediction of clinical deterioration in sepsis patients. Symphony IL-6 testing, in conjunction with clinical and other diagnostic findings, may enable healthcare providers to better prioritize appropriate care for those at high risk to help prevent adverse outcomes, and potentially avoid unnecessary investigations and treatments in those at low risk.
IL-6 appears as a ‘first responder’ biomarker in the blood during early stages of inflammations and/or infection. A current unmet challenge for healthcare professionals to overcome is the amount of time it takes to identify sepsis in patients and determine disease severity. Existing technologies typically take several hours to deliver IL-6 results, which can delay critical treatment decisions that could improve patient outcomes. The significance of IL-6 testing was highlighted during the COVID-19 pandemic, where elevated IL-6 levels in critically ill patients served as a predictive prognosis biomarker for disease severity.