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Vela Diagnostics Receives CE-IVD Mark for COVID-19 Detection Test

By LabMedica International staff writers
Posted on 27 Apr 2020

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Vela Diagnostics (Singapore) has received the CE mark for in vitro diagnostic use for the manual version of its ViroKey SARS-CoV-2 RT-PCR Test which detects SARS-CoV-2 in patients suspected of COVID-19 by their healthcare providers.

The ViroKey SARS-CoV-2 RT-PCR Test is a probe-based reverse transcription PCR test that detects the virus by targeting conserved regions of the SARS-CoV-2 genome. Vela was recently awarded a USD 225,000 contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, to develop manual and automated tests to detect SARS-CoV-2. Under the agreement, Vela Diagnostics will perform verification and clinical validation of the ViroKey SARS-CoV-2 RT-PCR Test to be used on automated and manual workflows for Emergency Use Authorization (EUA) submission to the US Food and Drug Administration (FDA).

The manual version of the assay enables quick adoption of the test by laboratories with existing Applied Biosystems 7500 Fast Dx (ABI 7500 Fast Dx) instruments. Vela has also developed an automated version of the test which is slated for CE-IVD registration in April 2020. The automated ViroKey SARS-CoV-2 RT-PCR Test is optimized for a workflow consisting of the Sentosa SX101 instrument, in conjunction with the Sentosa SA201 instrument or the ABI 7500 Fast Dx.

"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," said Sam Dajani, Acting CEO and Chairman of the Board.

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