- AnteoTech (ADO) has received CE Mark registration for its rapid test platform and COVID-19 test
- With CE Mark registration achieved for the EuGeni Reader and COVID-19 ART, the company is now a recognised lateral flow immunoassay rapid test manufacturer
- The results from this test can identify the presence of the SARS-CoV-2 antigen as an aid in the diagnosis of COVID-19 infection
- An official product launch for the EuGeni Reader and COVID-19 ART will be held later this month in Brisbane
- Company shares are up 8 per cent, trading at 27 cents
AnteoTech (ADO) has received Conformitè Europëenne (CE) Mark registration for its rapid test platform and COVID-19 test.
With CE Mark registration achieved for the EuGeni Reader and the in-vitro rapid diagnostic test for the detection of SARS-CoV-2 nucleocapsid antigen, or the COVID-19 ART, the company is now a recognised lateral flow immunoassay rapid test manufacturer.
The EuGeni COVID-19 Antigen Rapid Test is a single use, disposable immunochromatographic rapid diagnostic test can be used by healthcare professionals for the detection of SARSCoV-2 nucleocapsid antigen in nasopharyngeal specimens, collected from patients who are suspected the carry the COVID-19 infection.
The results from this test can identify the presence of the SARS-CoV-2 antigen as an aid in the diagnosis of COVID-19 infection. The EuGeni COVID-19 ART has an overall sensitivity of 97.3 per cent and specificity of 99.6 per cent.
The CE Mark registration confirms the tests meets the health and safety protection standards for products sold within the European Economic Area and the United Kingdom.
It also supports the sale of AnteoTech’s EuGeni Reader and the COVID-19 ART, which uses the AnteoBind Activated Europium technology, to deliver a high performing and high sensitivity test.
“We are delighted to have achieved this significant milestone in our strategy to become a legal manufacturer of rapid tests. It is a transformative moment, the culmination of twelve months of intensive effort,” said AnteoTech CEO Derek Thomson.
“CE Mark for the COVID-19 ART provides us with an opportunity to capture some of the large and growing European antigen rapid test market. We believe we have a superior test with high sensitivity and specificity based on our unique AnteoBind technology”.
“We will soon enhance this offering with a saliva use case and new COVID-19/Flu A/Flu B Multiplex test, which will give us a very strong competitive advantage over other products currently on the market.”
The company says testing platform will provide the basis of a new revenue stream.
This revenue stream is expected to grow with the addition of both the COVID-19 suite of tests and the development of a range of new diagnostic solutions in the areas of infectious, bacterial and viral conditions.
Following initial introductions and discussions with distributors over the past weeks, the approval will allow AnteoTech to formalise marketing and distribution discussions. With this, the company aims to capture a share of the growing antigen rapid testing market in Europe and the UK.
The EuGeni reader base established from this program will be leveraged with the introduction of new tests that require rapid diagnostics to deliver critical clinical decision support and have the potential for a high level of market demand.
An official product launch for the EuGeni Reader and COVID-19 ART will be held later this month in Brisbane.
Company shares are up 8 per cent, trading at 27 cents at 11:10 am AEST.