- AnteoTech (ADO) is looking to obtain Australian Therapeutic Goods Administration approval for its rapid COVID-19 diagnostic test
- ADO confirmed it had submitted documentation to the regulatory body for its EuGeni Reader platform and SARS-CoV-2 Antigen Rapid Diagnostic Test
- If and when approval is granted, ADO hopes to register the devices on the Australian Register of Therapeutic Goods to pursue commercialisation
- AnteoTech shares were up 0.91 per cent to trade at 27.8 cents at 12:52 pm AEST
AnteoTech (ADO) is looking to obtain Australian Therapeutic Goods Administration approval for its rapid COVID-19 diagnostic test.
Anteotech informed investors it had submitted documentation to the regulatory body for its EuGeni Reader platform and SARS-CoV-2 Antigen Rapid Diagnostic Test, which are designed to detect the presence of COVID-19 in humans.
In submitting its application, ADO hopes to earn a place for its testing devices on the Australian Register of Therapeutic Goods which would allow the company to progress the marketing, sale and use of its products in Australia.
AnteoTech is seeking to register the EuGeni Reader platform as a Class I IVD
Medical Device and its SARS-CoV-2 RDT as a Class III IVD Medical Device under TGA guidelines.
ADO affirmed receiving TGA approval for registration would be a “significant benchmark for the efficacy and quality of the products in other large markets”.
AnteoTech Chief Executive Officer Derek Thomson commented on the update.
“If TGA approval for registration is secured it will be another key milestone in commercialising EuGeni for the Australian market and establishing its reputation as the gold standard rapid test for SARS-CoV-2,” he said.
“As well, a number of other countries in the region with large populations regard TGA approval as a critical benchmark of a product’s efficacy, so we expect this initiative, if successful, to open up additional sales channels for the company.”
AnteoTech shares were up 0.91 per cent to trade at 27.8 cents at 12:52 pm AEST.