Vela Diagnostics' ViroKey SARS-CoV-2 RT-PCR Test Granted FDA Emergency Use Authorization

Vela Diagnostics (Singapore) has obtained Emergency Use Authorization from the US Food and Drug Administration (FDA) for the manual version of its probe-based reverse transcription PCR test that detects SARS-CoV-2.

Vela’s ViroKey SARS-CoV-2 RT-PCR Test detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs by targeting conserved regions of the viral genome. The manual version of the ViroKey SARS-CoV-2 RT-PCR Test enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments. For high throughput testing, Vela has also developed an automated version of the assay optimized for a workflow consisting of the Sentosa SX101 instrument, in conjunction with the Applied Biosystems 7500 Fast Dx Real-Time (ABI 7500 Fast Dx) PCR instrument or the Sentosa SA201 instrument.

The EUA allows the emergency use of FDA medical products in qualified labs, thus facilitating widespread access to Vela’s ViroKey SARS-CoV-2 RT-PCR Test. In addition to being authorized by the FDA for emergency use, the test has also received the CE mark and provisional approval from the Singapore Health Sciences Authority.

"RT-PCR is currently the gold standard for diagnosing SARS-CoV-2 infections. Given the escalating number of COVID-19 cases in the US, Vela Diagnostics is helping Americans get tested so as to detect and slow the spread of the virus," said Sam Dajani, interim CEO and Chairman of the Board. "Our coronavirus test will assist healthcare professionals in managing the COVID-19 pandemic."

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