Bluejay Completes Planned Clinical Studies for Symphony IL-6 Test
Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay”, “the Company”), a medical diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression, today announced completion of its previously planned clinical studies for the Symphony IL-6 Test (the “Test”). Results of these studies will be published at the 2022 AACC Annual Scientific Meeting being held July 26th to 28th in Chicago.
Neil Dey, Chief Executive Officer, said, “Completion of these studies, which consist of our previously disclosed reference range study, cut-off value study and cut-off validation study, marks an important milestone towards a potential filing of our de Novo Marketing Application with FDA by the end of the year. Our recently announced plan to pursue a de Novo regulatory pathway could establish the Symphony IL-6 test as the new standard for measuring IL-6 using whole blood and serve to validate the innovative nature our technology.”
Neil Dey continued, “Efficient measurement of clinically relevant biomarkers in critical care settings may help medical professionals make more timely and effective treatment decisions. With the progress made in our clinical program for the Symphony IL-6 Test, we are closer to executing our mission of providing first-in-class, near-patient, laboratory quality tests using whole blood.”
About the Symphony System:
Bluejay’s Symphony System (the “System”) is designed to address the need for simple, reliable and rapid near-patient testing by providing quantitative measurements of specific biomarkers to determine the need for additional patient care and monitoring. The user-friendly System does not require any sample prep 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.
About Bluejay Diagnostics:
Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient product for triage and monitoring of disease progression. Bluejay’s first product candidate, the Symphony IL-6 Test for sepsis triage, is designed to provide accurate, reliable results in approximately 20 minutes from ‘sample-to-result’ to help medical professionals make earlier and better triage/treatment decisions.