Vela Diagnostics receives CE-IVD approval and Provisional Authorisation from the Health Sciences Authority in Singapore for automated COVID-19 detection test

SINGAPORE, July 13, 2020 /PRNewswire/ -- Vela Diagnostics announced today that an automated version of its COVID-19 detection test, the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0, has received the CE mark for in vitro diagnostic use as well as Provisional Authorisation from the Health Sciences Authority in Singapore.

The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 is a probe-based reverse transcription PCR Test that detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 genome, specifically the ORF1a and N genes. The automated test is optimized for a workflow consisting of the SentosaSX101 instrument, in conjunction with the SentosaSA201 instrument or the ABI 7500 Fast Dx. The automated workflow enables high throughput testing with significantly reduced hands-on time. Up to 48 tests, including controls, can be performed in a single run. "Receiving CE certification and Provisional Authorisation from the Health Sciences Authority in Singapore for our automated test facilitates efficient testing of SARS-CoV-2 in patients suspected of COVID-19 in Europe, Africa, Middle East and Asia, where there is an urgent need to identify individuals infected with SARS-CoV-2 for effective management of the global pandemic," said Managing Director, Andreas Goertz.

In April this year, an earlier version of the test, the ViroKey™ SARS-CoV-2 RT-PCR Test, also received the CE mark and Provisional Authorisation from the Health Sciences Authority in Singapore.

About Vela Diagnostics

Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA's test solutions utilize the automated Sentosaplatform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.

All Sentosaproducts listed above are by Vela Diagnostics. For more information, visit www.veladx.com.

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SOURCE Vela Diagnostics

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