De Novo Update – FDA Supervisory Review

Oxford, UK. GENinCode Plc (AIM: GENI), the genetics company focused on the prevention of cardiovascular disease, announces an update on its Food and Drug Administration (FDA) De Novo submission. In response to a request by the Company for a Supervisory Review, the FDA recently provided a review of its April 2025 assessment. While the number of the outstanding deficiencies has been reduced, the review upheld the FDA's prior view that there remains certain outstanding elements, including further information in relation to clinical validation.

With the feedback from the Supervisory Review, the Board remains of the view that there is a path forward to provide the further information to resolve these deficiencies to obtain De Novo classification. Discussions with the FDA have been productive with the outstanding deficiencies reducing. The Board does not believe that there are any elements that it cannot address, however there can be no certainty that the information provided will be sufficient.

The Company has arranged further ongoing clarifictory discussions with the FDA and will provide a further update if this provides additional information.