NEW YORK – Lateral flow diagnostic company Innova announced on Tuesday that its SARS-CoV-2 rapid antigen test has received CE marking under Europe's new In Vitro Diagnostic Regulation (IVDR) rules.
The CE mark, received from notified body GMED LNE Group, will allow the firm to sell its Innova SARS-CoV-2 Antigen Rapid Qualitative Self-Test across Europe. The test, which detects multiple proteins in the SARS-CoV-2 virus, had previously been approved for distribution in the UK, Israel, Malaysia, Oman, and Qatar, Innova said in a statement. Since the start of the pandemic, the Pasadena, California-based company has delivered more than 1.5 billion lateral flow tests globally.
"This new European certification only underscores our ongoing commitment to provide effective, high-quality diagnostic products at reasonable prices to more people around the world," Robert Kasprzak, CEO of Innova Medical Group, said in a statement.
The test previously received CE marking for self-testing under Europe's original IVD Directive in March. Europe's new IVDR regulations intended to enforce stronger safety and quality standards went into effect on May 26.