FDA issues Emergency Use Authorization to Vela Diagnostics' Coronavirus PCR Test

Vela Diagnostics announced the manual version of its coronavirus PCR test has obtained Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). By targeting conserved regions of the viral genome, the probe-based reverse transcription PCR test detects SARS-CoV-2, the coronavirus that causes COVID-19. The EUA allows the emergency use of FDA medical products in qualified labs, thus facilitating widespread access to the diagnostic test.

"RT-PCR is currently the gold standard for diagnosing SARS-CoV-2 infections. Given the escalating number of COVID-19 cases in the U.S., 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."

The ViroKey™ SARS-CoV-2 RT-PCR Test detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs. 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 Diagnostics 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.

In addition to being authorized by the FDA for emergency use, the ViroKey™ SARS-CoV-2 RT-PCR Test has also received the CE mark and provisional approval from the Singapore Health Sciences Authority.