- CE mark provides another important validation for the Innova SARS-CoV-2 Antigen Self-Test product
- The Innova test has been widely used in the UK under EUA since late 2020
- Innova plans to bring the product direct to consumers in the EU and the UK to help make at home testing more accessible at equitable prices
PASADENA, Calif., March 23, 2022 /PRNewswire/ -- Innova Medical Group, Inc., a global health screening and diagnostic innovator and a world leader in the manufacture and distribution of COVID-19 rapid tests, announced today that the Innova SARS-CoV-2 Antigen Rapid Qualitative Test has received a CE Mark for self-testing. The UK also continues to accept CE accreditation for entry of products on its markets.
The Innova SARS-CoV-2 Antigen Rapid Qualitative Test is one of the most studied lateral flow tests in the world. Data from 1.7 million tests from independent studies in lab and field settings demonstrated that the Innova SARS-CoV-2 Antigen Rapid Qualitative Test is highly effective in detecting infected individuals who are considered infectious to others.
"The CE Mark is yet another important milestone for our Rapid Antigen Test," said Daniel Elliott, Chief Executive Officer, Innova Medical Group. "We look forward to continuing our work with great partners as we expand our market presence further in our goal to bring our product to even more consumers and help make at home testing accessible to all."
Innova's Chief Regulatory Officer, Doug Woodruff, added, "Receiving the EC design-examination certificate is yet another example of independent third-party assessment that the product meets European performance and safety standards for self-testing."
Since late 2020, the Innova SARS-CoV-2 Antigen Rapid Qualitative Test has been widely used in the UK as the COVID test kit provided to the UK population by the National Health Security Agency pursuant to an Emergency Use Authorization issued by Medicines and Healthcare products Regulatory Agency (MHRA). The Innova SARS-CoV-2 Antigen Rapid Qualitative Test has been approved for distribution in 18 countries including for both point of care and self-testing products, with numerous applications processing. With approximately 2 billion units sold and distributed, the Innova SARS-CoV-2 Antigen Rapid Qualitative Test is among the best-selling products in the industry across the globe.
About Innova Medical Group
Innova Medical Group is a global health screening and diagnostic innovator driven to dramatically improve health outcomes worldwide with equitable, high-value testing solutions. Our strategic and iterative approach enables us to create, build and deploy a myriad of accessible tests customized to meet and empower the user at their point of need. www.innovamedgroup.com
