Vela Diagnostics receives FDA EUA for PCR test

Vela Diagnostics has received Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for the manual version of its Covid-19 polymerase chain reaction (PCR) test.

The ViroKey SARS-CoV-2 RT-PCR Test detects the Covid-19 causing SARS-CoV-2 virus in nasopharyngeal and oropharyngeal swabs, and can be processed quickly and flexibly by laboratories with existing ABI 7500 Fast Dx instruments.

Vela Diagnostics has also developed an automated version of the ViroKey assay, designed to be used with the Sentosa™ SX101 instrument, in conjunction with the Applied Biosystems 7500 Fast Dx Real-Time (ABI 7500 Fast Dx) PCR instrument or the Sentosa™ SA201 instrument.

The test has also received the European CE mark and provisional approval from the Singapore Health Sciences Authority.

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