- AnteoTech (ADO) has once again been asked by the Therapeutic Goods Administration to provide more clinical data for the submission of its COVID-19 testing devices
- Since September, AnteoTech has been trying to get its EuGeni Reader platform and SARS CoV-2 Ag Rapid Diagnostic Test (RDT) products approved for use in Australia
- After numerous requests for additional data and information, AnteoTech decided the most efficient path is to conduct new clinical studies
- The company says this offers the chance to compile the data from studies in Australia and Europe and present this as a fresh submission to the TGA
- ADO shares were down 6.38 per cent to 22 cents
AnteoTech (ADO) has once again been asked to provide additional clinical data to the Therapeutic Goods Administration (TGA) for the submission of its COVID-19 testing devices.
The healthcare stock is looking to have its EuGeni Reader platform and SARS CoV-2 Ag Rapid Diagnostic Test (RDT) products approved for use in Australia. They are both designed to detect the presence of COVID-19 in humans.
AnteoTech first submitted documents to the regulatory body for the EuGeni Reader platform and SARS-CoV-2 Antigen RDT in September last year to earn a place for its testing devices on the Australian Register of Therapeutic Goods.
Since then, it has gone back and forth with the TGA which has, on more than one occasion, requested further information to support the submission. In December, the regulator asked for additional information, including AnteoTech’s plans in the face of potential new strains of COVID-19.
In January, AnteoTech submitted the requested information, however the TGA came back with a request for additional clinical data and said it would continue to collaborate with AnteoTech to work through the specifics and how best to address the requirements.
After discussions with the TGA regarding additional clinical data and how best to provide that, AnteoTech has decided that conducting new clinical trials represents the most “expeditious pathway” to meeting the data requirements.
AnteoTech said this gives it the flexibility and opportunity to compile the new data from studies in Australia and Europe and present this as a fresh submission to the TGA.
The trials are also aimed at providing further performance-based evidence relating to new variants of concern listed by the World Health Organisation.
“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,” AnteoTech CEO Derek Thomson said.
The company’s shares were down 6.38 per cent to trade at 22 cents at 1:23 pm AEDT.