AnteoTech (ASX:ADO) has announced it has received Conformitè Europëenne (CE) Mark registration for its EuGeni Reader and the in vitro rapid diagnostic test for the detection of SARS-CoV-2 nucleocapsid antigen, the COVID-19 ART.
The CE Mark registration confirms that the EuGeni Reader and the COVID-19 ART conform with health and safety protection standards for products sold within the European Economic Area (EE) and the UK.
With CE Mark achieved, AnteoTech is now a recognised lateral flow immunoassay rapid test manufacturer, said the company.
it said the EuGeni Rapid Test Platform provides the basis of a potential new potential revenue stream that is expected to grow with the addition of not only the proposed COVID-19 suite of tests but also the development of a range of new diagnostic solutions in the areas of infectious, bacterial and viral conditions.
AnteoTech said its commercialisation strategy is to drive initial sales of EuGeni readers into key markets via the COVID-19 ART and the COVID-19/Flu A/Flu B Multiplex tests.
"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," said the company, adding, "The first of these will be a quantitative test for Sepsis, the body’s extreme and life-threatening response to infection."
AnteoTech CEO Derek Thomson said, “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.
“The EuGeni Platform provides a strong foundation for us to grow a suite of qualitative and quantitative tests for the Point-of-Care market and I am excited by the immediate opportunity and the leverage opportunities that lie ahead of us.
“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.
“I’d like to commend the commitment, dedication and skills of the entire Life Science team at AnteoTech under the leadership of Dr Charlie Huang. They are a very small team of talented people that have achieved outstanding results. From very humble beginnings, Charlie and his team have helped to accelerate our Company beyond what we originally envisaged in the time frame of this development. I would also like to thank the Queensland Government for their contribution through the Essential Goods and Supply Chain Program, to the commercialisation of our test and platform.”