Seegene Gets CE-IVD Mark for COVID-19 Test

Molecular diagnostics company Seegene has received a CE-IVD mark for its Allplex SARS-CoV-2 fast MDx assay.

The South Korean company says the test can deliver results within 30 minutes, while matching the accuracy of polymerase chain-reaction (PCR) tests.

The assay, which is sensitive enough to detect the coronavirus even in asymptomatic patients, does not require a thermal cycler during the amplification process, which reduces the turnaround time, the company said.