Vela Diagnostics' SARS-CoV-2 RT-PCR Test v2.0 Authorized for Emergency Use in the U.S.

FAIRFIELD,N.J.,Sept. 23,2020 -- Vela Diagnostics announced today that the ViroKey™SARS-CoV-2 RT-PCR Test v2.0 has obtained the Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This automated probe-based reverse transcription PCR test detects SARS-CoV-2,the coronavirus responsible for COVID-19,in nasopharyngeal and oropharyngeal swabs. With the EUA,laboratories in the United States certified under the Clinical Laboratory Improvement Amendmentswill now be able to use the test for COVID-19 detection.

"Receiving the EUA for our automated COVID-19 detection kit will enable us to better assist laboratory and healthcare personnel in managing the pandemic in the U.S.," said Sam Dajani,CEO and Chairman of the Board.

The ViroKey™SARS-CoV-2 RT-PCR Test v2.0 is an automated probe-based reverse transcription PCR test optimized for a workflow consisting of Vela Diagnostics' Sentosa®SX101 and the Sentosa®SA201 instrument (or ABI 7500 Fast Dx). The automated test enables high throughput testing of up to 46 samples in a single run,with reduced hands-on time.

Besides receiving EUA from the FDA,the ViroKey™SARS-CoV-2 RT-PCR Test v2.0 has also received the CE mark and Provisional Authorisation from the Singapore Health Sciences Authority.

About Vela 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.

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