- Anteotech (ADO) successfully registers its updated EuGeni COVID-19 Rapid Antigen Test (RAT) in Europe under In Vitro Diagnostic Directive (IVDD) regulations
- The new registration strengthens the product’s competitive position as it broadens the sampling methods available to detect COVID-19
- Anteotech says this will also provide additional leverage as the company expands the RAT’s footprint in Europe
- The company currently has a European trial underway evaluating the updated multiple-use claim to enable it to be included in the EU Common List registration application
- Shares in Anteotech are up 27.66 per cent to 12 cents each at 10:53 am AEST.
Anteotech (ADO) has successfully registered its updated EuGeni COVID-19 Rapid Antigen Test (RAT) in Europe under In Vitro Diagnostic Directive (IVDD) regulations.
The new registration is for the same core Anteotech rapid diagnostic test registered in April 2021 but now covers multiple use claims to include combined nose and throat sampling and nasal mid-turbinate sampling on top of the original nasopharyngeal sampling method.
To establish the new use claims, the company completed analytical and clinical performance evaluations in the US and the UK, respectively, that focussed on validating the test’s effectiveness in detecting the Omicron variant of COVID-19.
The company said the new registration strengthened the RAT product’s competitive position as it broadened and aligned sampling methods to current trends in standard of care for the European market.
The updated test will also provide additional leverage as Anteotech expands the RAT’s footprint in Europe.
The company currently has a European Clinical Trial underway evaluating the updated multiple-use claim to enable this to be included in the EU Common List registration application.
AnteoTech said as it received orders for the updated multiple-use claim test kits, the original nasopharyngeal test would be phased out.
Shares in Anteotech were up 27.66 per cent to 12 cents each at 10:53 am AEST.