AnteoTech (ASX:ADO) has registered an updated EuGeni COVID-19 Rapid Antigen Test (RAT) in Europe under the In Vitro Diagnostic Directive (IVDD) 98/79/EC Regulations.
The company said the new registration strengthens the EuGeni COVID -19 RAT’s competitive position as it broadens and aligns sampling methods to current trends in standard of care for the European market.
It said the new registration is for the same core SARS-CoV-2 Ag 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, AnteoTech completed analytical and clinical performance evaluations in the US and the UK that focussed on validating the test’s effectiveness in detecting the Omicron variant of SARS-CoV-2.
AnteoTech said this work will be used in future regulatory submissions. It added the European Clinical Trial currently underway is also evaluating the updated multiple-use claim, to enable this to be included in the EU Common List registration application.
“As AnteoTech receives orders for the updated multiple-use claim test kits, the original nasopharyngeal test will be phased out,” added the company.
