Omixon Receives CE Mark for COVID-19 RT-PCR Test

Omixon has gained CE mark certification for its AzureSeq-200 CE in vitro diagnostic, a COVID-19 reverse transcription polymerase chain reaction (RT-PCR) test.

The kit is the first COVID-19 test to be cleared in Europe that does not require RNA extraction without closed systems, the company said.

Tests that require RNA extraction take significantly longer and require costly reagents that can be hard to get during the pandemic. The automation-friendly test takes less than two hours to deliver results and requires fewer steps, reducing the chances of human error, Omixon said.