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 -- 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 theSentosa™ SX101 instrument,in conjunction with theSentosa™SA201 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.

AboutVela Diagnostics

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

AllSentosa™products listed above are by Vela Diagnostics. For more information,visitwww.veladx.com.