AnteoTech hit by new COVID test trials

AnteoTech shares slumped on Thursday after the biochem company provided an update on its Therapeutic Goods Administration (TGA) submission for its rapid COVID test.

In response to TGA’s review of the company’s EuGeni Reader and SARS CoV-2 Ag Rapid Diagnostic Test (RDT), AnteoTech said it intends to collect further clinical data based on samples collected from patients and immediately analysed on the EuGeni Reader.

AnteoTech said it has had ongoing discussions with the TGA over the past week, which were 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. As a result, it was 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 the new trials will ensure that a new submission by AnteoTech will meet the TGA’s regulatory requirements, as well as provide 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, lower limit of detection and other performance measures from a vaccinated population.

By undertaking a new submission, AnteoTech said it has the flexibility and opportunity to compile the new clinical data from studies in Australia and Europe and present this as a new and unencumbered submission to the TGA.

CEO Derek Thomson said: “We have worked directly with the TGA to understand the most efficient method of supplying the data they now require and our highest priority is to generate this data as quickly as possible. These further trials will provide AnteoTech with the opportunity to gain additional clinical data which will enhance the growing body of evidence for performance of both the EuGeni Reader and the RDT.”