Benzinga | Jan 31, 2022 07:05AM EST

Bluejay Diagnostics, Inc. Announces its Pre-Submission Filing Package For The Symphony IL-6 Test Is With The FDA

Bluejay Diagnostics, Inc. (NASDAQ:BJDX) ("Bluejay", "the Company") a late-stage, pre-revenue diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression, today announced that it has filed a Pre-Submission package for the Symphony IL-6 Test with the U.S. Food and Drug Administration ("FDA" or "the agency"). The purpose of this filing is to request feedback from the agency prior to submitting a medical device marketing application. The pre-submission package will allow the FDA to review and comment on the Company's plans for clinical trials and analytical testing.

Neil Dey, Bluejay's Chief Executive Officer commented, "I am very pleased to announce that Bluejay successfully met its goal of filing the pre-submission package with the FDA for the Symphony IL-6 Test by the end of January, 2022. Bluejay is developing the Symphony IL-6 Test to rapidly measure IL-6 in whole blood in a near-patient setting that is intended to help healthcare professionals make better treatment decisions for patients with life threatening diseases. The pre-submission filing an important milestone for Bluejay as we will receive important feedback from the FDA for our planned marketing submission for the Symphony IL-6 Test, planned for Q3:22."

About Interleukin-6

Interleukin-6 (IL-6) is an established biomarker of immune system activation. It is elevated in infection, inflammation, and cancer. IL-6 presents as an early "first responder" and needs to be measured quickly and reliably.

About the Symphony IL-6 Test Program

Bluejay's initial testing program is proceeding as planned to support the Pre-Submission filing with the FDA, as announced today, and the overall product development program. This testing program includes multiple studies, all intended to demonstrate the performance and safety of the IL-6 test. This clinical program will continue in anticipation of the company's planned marketing application.

About the SymphonyTM System:

Bluejay's Symphony System (the Symphony System) is intended to address the need for simple, reliable, rapid near-patient testing. The Symphony System is designed to provide quantitative measurements of specific biomarkers to determine the need for additional patient care and monitoring, when used in combination with other test and laboratory measurements. The system does not require any sample prep and was shown in published clinical studies to deliver results in about 24 minutes.

This user-friendly system is expected to fit into ICU/near-patient settings without the need for dedicated staff to run a test. The system has been designed to measure test analytes using whole blood. Samples are collected and loaded into proprietary, test-specific cartridges.

The Symphony System is based on a well-accepted test method (ELISA, Enzyme-Linked Immunosorbent Assay) using advances in nanotechnology and new approaches to microfluidics. Bluejay has an exclusive license to the Symphony System from Toray Industries (Toray), a multinational company with more than 96 years of manufacturing experience, located in Japan. The product is manufactured by Toray and Sanyoseiko. Sanyoseiko is an FDA-registered manufacturer with more than 50 years of global experience in medical devices manufacturing, located in Japan.

The Symphony IL-6 Test ("Symphony IL-6 Test") is currently Bluejay's lead product candidate. The Company completed a Pre-submission filing for the Symphony IL-6 Test on January 31, 2022.

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.