Bluejay Diagnostics, Inc. reported that it has completed 90 subjects in the prospective multicenter clinical study addressing rapid IL-6 test for COVID-19 patients with critical care. This study performs unique rapid on-site measurement using patient whole blood and positions the Company to move forward with multiple initiatives. Bluejay conducted its multicenter clinical study at two sites at the University of Texas Southwestern Medical Center's (William P. Clements Hospital and Zale Lipsey Pavilion Hospital), and at Parkland Memorial Hospital, all located in Dallas, Texas.

These studies mark the first of their type, in which IL-6 is quantified directly from the whole blood of COVID-19 (SARS-CoV-2 positive) patients in critical care. The results from this multicenter study are currently being prepared for submission for scientific peer review and publication in the Q3:22 timeframe. The study objectives were several fold including: 1) validating the use of unprocessed whole blood for the measurement of IL-6 (compared with the multistep laboratory processing required in current IL-6 measurements); 2) comparison of the Symphony produced measurement values relative to other current standard laboratory tests; 3) generation of the clinical data to support moving the Symphony IL-6 testing into potential commercial use; and 4) producing the results needed to support further approvals through FDA processes.

Bluejay intends to file its Pre-Submission application with the FDA in January 2022 for the Symphony IL-6 Test and to initiate an expanded clinical testing program. The results from this clinical program will form the basis of the Company's planned 510(k) marketing application, intended to be submitted in Q3:22.