Research & Development
Vela Diagnostics awarded FDA's EUA for the ViroKey SARS-CoV-2 RT-PCR Test
6 August 2020 -

Polymerase chain reaction company Vela Diagnostics stated on Wednesday that the manual version of its coronavirus PCR test, called The ViroKey SARS-CoV-2 RT-PCR Test, has received the US Food and Drug Administration's (FDA) Emergency Use Authorization for the detection of SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs.

The company added that the manual version of the ViroKey SARS-CoV-2 RT-PCR Test enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments.

In conjunction with high throughput testing, the company has developed an automated version of the assay optimized for a workflow consisting of the Sentosa SX101 instrument and the Applied Biosystems 7500 Fast Dx Real-Time (ABI 7500 Fast Dx) PCR instrument.

Additionally, the company's ViroKey SARS-CoV-2 RT-PCR Test has received the CE mark and provisional approval from the Singapore Health Sciences Authority.