SARS-CoV-2 RT-PCR Test v2.0 Granted Authorized for Emergency Use in US

Vela Diagnostics announced 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 Amendments will 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 Authorization from the Singapore Health Sciences Authority.