AnteoTech Ltd. provided an update on its Therapeutic Goods Administration (TGA) submission for the registration of its EuGeni Reader and SARS CoV-2 Ag Rapid Diagnostic Test (RDT). In response to TGA's review of the submission, AnteoTech intends to collect further clinical data based on samples collected directly from patients and immediately analysed on the EuGeni Reader (prospective samples). Australian and European clinical research organizations are coordinating these clinical trials.

AnteoTech has had ongoing and constructive discussions with the TGA over the past week. These discussions focused on the reconciliation of AnteoTech's clinical data set, which includes stored and direct patient samples, and the TGA's requirements for additional clinical evidence. Following these discussions, it has been concluded that AnteoTech's proposed approach of conducting new clinical trials represents the most expeditious pathway to meeting these data requirements.

The data generated from these trials will ensure that a new submission by AnteoTech will meet the TGA's regulatory requirements, as well as providing the Company with data for additional regulatory approval processes, including registration for the EU Common List. The trials will also provide further evidence of performance relating to new variants of concern listed by the World Health Organisation ("WHO"), lower limit of detection and other performance measures from a vaccinated population. By undertaking a new submission, AnteoTech has the flexibility and opportunity to compile the new clinical data from studies in Australia and Europe and present this as a fresh and unencumbered submission to the TGA.

AnteoTech will provide updates as key milestones are achieved.