NEW YORK – Gemina Laboratories announced on Tuesday that its Gemina Legio X COVID-19 Rapid Antigen Test has received CE marking.
The antigen test, which uses a biosensing chemistry platform to detect the virus from shallow nasal swab samples, correlated with PCR testing in the high 90th percentile in an Italian clinical trial of 500 subjects, the Vancouver, British Columbia-based firm said in a statement.
The CE mark will allow the company to bring the test to market in EU member countries, and Gemina is working with its Canadian manufacturing partner International Point of Care to manufacture and commercialize the test in the second half of 2022. The CE mark is Gemina's first regulatory approval, and the company is "actively exploring pathways for additional approvals in Europe and beyond," it said.
"Within two years, we've developed an incredibly powerful biosensing chemistry platform, and developed our first regulated product based on the strength of that platform," Gemina Chief Technology Officer Rob Greene said in a statement. "We've formulated a great set of targets for our successor products over the next three years, including our previously announced Flu A/B rapid test, which leverages the experience we've already developed in the COVID-19 space."
The test's CE mark was received under the EU's In Vitro Diagnostic Medical Device Directive (IVDD), which only requires a self-certification process. But under Europe's new In Vitro Diagnostic Regulations — which go into effect May 26 — tests must be assessed by a designated notified body. The regulations will apply retroactively to tests that have received CE marking, although the transition periods for different classes of in vitro diagnostics to achieve compliance have been extended until at least 2024.