Bluejay Reports FDA Agrees to Consider its Plan to Pursue a De Novo Regulatory Pathway for the 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 that the FDA has agreed to consider Bluejay’s plan to pursue a De Novo submission for the Symphony IL-6 Test.
In written feedback to the January 2022 submission of the FDA pre-submission briefing package, the FDA stated that Bluejay’s Symphony IL-6 Test could be considered for the De Novo pathway.
Neil Dey, Chief Executive Officer, said “We are excited for the opportunity to pursue the De Novo regulatory pathway. This confirms our belief that the Bluejay Symphony IL-6 Test has the potential to provide an innovative solution to the market. Bluejay continues to advance the Symphony IL-6 Test towards the Company’s anticipated marketing application with the FDA, expected by year-end 2022.”
About the De Novo Classification
If it is determined that there is not a legally marketed class I or class II device upon which to base a determination of substantial equivalence and a device is considered to be of low to moderate risk, the FDA may make a determination to classify the product candidate as a De Novo application, rather than the more conventional 510(k) marketing application. Information related to the De Novo classification can be found through the following link: De Novo classification.
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 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, an 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.