FDA Authorizes Vela’s COVID-19 PCR Test for Emergency Use

The FDA has granted Vela Diagnostics an Emergency Use Authorization for a manual version of its coronavirus polymerase chain reaction (PCR) test.

The agency has authorized the ViroKey SARS-CoV-2 RT-PCR diagnostic for use on ABI 7500 Fast Dx instruments in qualified laboratories. It works by detecting the genetic code of the coronavirus.

The test has also earned a CE mark in Europe and a provisional approval in Singapore.