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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

Benzinga · 06/09/2022 07:32

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.”