Bluejay Diagnostics has struck a promising new deal with regulators.

 

This morning, the diagnostics company announced that the US Food & Drug Administration has improved its plan to pursue a De Novo submission for its Symphony IL-6 Test.

 

In its written feedback to Bluejay's 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.

 

Bluejay CEO Neil Dey said on the subject, "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".

 

Dey also said, "Bluejay continues to advance the Symphony IL-6 Test towards the Company's anticipated marketing application with the FDA, expected by year-end 2022."

 

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