Vela Diagnostics’ Covid-19 detection test receives CE Mark

27 April 2020 (Last Updated April 27th, 2020 11:53)

Vela Diagnostics has received the CE Mark for the manual version of the ViroKey SARS-CoV-2 RT-PCR Covid-19 detection test for in vitro diagnostic use.

Vela Diagnostics’ Covid-19 detection test receives CE Mark
Vela Diagnostics has developed the manual version of the assay to enable quick adoption of the test by laboratories. Credit: Christian C Gruber Georg Steinkellner.

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Vela Diagnostics has received the CE Mark for the manual version of the ViroKey SARS-CoV-2 RT-PCR Covid-19 detection test for in vitro diagnostic use.

The probe-based reverse transcription PCR test detects SARS-CoV-2 virus in patients suspected of Covid-19.

It detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 genome. The manual version of the assay allows quick adoption of the Covid-19 detection test by laboratories with existing Applied Biosystems 7500 Fast Dx (ABI 7500 Fast Dx) instruments.

Vela Diagnostics acting CEO and Board chairman Sam Dajani said: “The CE mark enables Vela Diagnostics to expand Covid-19 testing capacity in Europe, where there is an urgent need to identify individuals infected with SARS-CoV-2.”

In addition, the company has developed an automated version of the test. Vela Diagnostics is expected to complete CE-IVD registration by the end of the month.

The automated ViroKey SARS-CoV-2 RT-PCR Test is optimised for a workflow, consisting of the Sentosa SX101 instrument combined with the Sentosa SA201 instrument or the ABI 7500 Fast Dx.

Last week, Vela Diagnostics was contracted by the Biomedical Advanced Research and Development Authority (BARDA) in the US to support the development of its Covid-19 tests. This $225,000 contract will allow the company to carry out verification and clinical validation of the ViroKey SARS-CoV-2 RT-PCR Test.

Meanwhile, more than 2,971,831 Covid-19 cases have been reported globally with the fatality rate reaching up to 206,553.

The US, which is now the epicentre of the pandemic, has recorded over 965,910 confirmed cases and 54,876 deaths.

A few of the hardest-hit European countries like Spain, Italy and France have seen a slight drop in the number of Covid-19 cases over the past two weeks.