Bluejay Diagnostics Inc. shares reversed course from Thursday’s gains, dropping 31% to $1.12 one day after saying the Food and Drug Administration has agreed to consider its plan to pursue a De Novo submission for its Symphony IL-6 test.
The stock ended Thursday’s session up 26%, and hit its 52-week low of 82 cents on March 8.
In written feedback to a January submission of a FDA pre-submission briefing package, the FDA said that Bluejay’s Symphony IL-6 test could be considered for the De Novo pathway.
Bluejay said it is continuing to advance the Symphony IL-6 test toward its anticipated marketing application with the FDA, expected by the end of 2022.
If a device is determined not to have 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.
About Bluejay Diagnostics
Bluejay Diagnostics, Inc. is a late-stage, pre-revenue diagnostics/medical device company focused on improving patient outcomes through the Symphony System, a more cost-effective, rapid, near-patient product candidate for triage and monitoring of disease progression in hospital and long-term acute care (LTAC) settings. Bluejay’s first product candidate, an IL-6 test for sepsis triage, is designed to provide accurate, reliable results in approximately 24 minutes from ‘Sample-To-Result’ to help medical professionals make earlier and better triage/treatment decisions.