- AnteoTech (ADO) receives a call for further information from the Therapeutic Goods Administration
- The new request relates to the collation of further clinical data on the company’s EuGeni Reader and SARS CoV- 2 Ag Rapid Diagnostic Test (RDT)
- ADO’s EuGeni product has been approved for use in Europe, but is still waiting on the green light from the TGA for approval for use in Australia
- AnteoTech recently supplemented its EuGeni studies by conducting a prospective clinical trial, which it hopes will meet the clinical data requirements set by the TGA
- AnteoTech last traded at 31.5 cents on January 27
AnteoTech (ADO) has received a request for further information from the Therapeutic Goods Administration.
Following the company’s submission of material last week, as requested by the TGA in December, AnteoTech received a request for further information on its EuGeni Reader and SARS CoV- 2 Ag Rapid Diagnostic Test (RDT).
The EuGeni Reader platform and AnteoTech’s SARS-CoV-2 Antigen RDT are designed to quickly and easily detect the presence of COVID-19 in humans.
Through working with the TGA collaboratively, the company hopes to nail the specifics of the request and how to best address the clinical data requirements.
AnteoTech recently supplemented its EuGeni studies by conducting a prospective clinical trial at the Department of Infectious Diseases, Clinical Research Unit at the Alfred Hospital and Burnet Diagnostic Initiative (BDI) at the Burnet Institute in Melbourne, to further evaluate the clinical performance of the EuGeni SARS- CoV-2 Ag RDT.
The company said it anticipates the trial will provide further data that may be required to meet the clinical data requirements set by the TGA.
However, due to the current Omicron wave of COVID-19 and the staffing strain on the health system, the company has been experiencing impacts to the timeline of the study.
AnteoTech’s EuGeni product has been approved for use in Europe, but is still waiting on the green light from the TGA for approval for use in Australia.
AnteoTech last traded at 31.5 cents on January 27.