International – EU OKs coronavirus test from Macrogen

European regulators have given CE mark approval to South Korea-based Macrogen for its Axen COVID-19 RT test that can deliver results within two hours.

South Korea’s Macrogen has received a CE mark for a new coronavirus test kit, Axen COVID-19 RT.

The test confirms if a patient is infected with the virus in approximately two hours through detection of two COVID-19-related genes.

The company said that the test showed 100 percent accuracy in 20 samples each of positive and negative patients in a clinical trial. It is currently awaiting a decision by the FDA for an Emergency Use Authorization.