Vancouver, Canada-based Gemina has received a CE mark for its first product, the Gemina Legio XTM COVID-19 rapid antigen test.

The certification was supported by results from a recent 500-subject clinical trial in Italy in which the results from the antigen test correlated “in the high 90th percentile” with the results from polymerase chain reaction testing, the company said.

Gemina is working with its Canadian manufacturing partner, International Point of Care, to manufacture and market the COVID-19 test in Europe in the second half of 2022. The company is also developing other rapid tests for medical diagnosis and human wellness monitoring, including an influenza A and B rapid test.