Vela Diagnostics announced that the ViroKey SARS-CoV-2 RT-PCR Test v2.0 has obtained Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), according to a press release. 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 (CLIA) 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.
