PCR testing company Vela Diagnostics reported on Tuesday the receipt of the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the ViroKey SARS-CoV-2 RT-PCR Test v2.0 to detect SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs.
Vela Diagnostics said its automated probe-based reverse transcription PCR test detects SARS-CoV-2, the coronavirus responsible for COVID-19. Laboratories in the US certified under the Clinical Laboratory Improvement Amendments can use the test for COVID-19 detection.
According to the company, 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 its 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.
In addition, the company's ViroKey SARS-CoV-2 RT-PCR Test v2.0 has received the CE mark and Provisional Authorisation from the Singapore Health Sciences Authority.
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