FDA issues EUA for Vela Diagnostics COVID-19 PCR test

Vela Diagnostics announced that it received FDA emergency use authorization (EUA) for the manual version of its coronavirus PCR test.

Fairfield, N.J.-based Vela designed its COVID-19 diagnostic to target conserved regions of the viral genome so the probe-based reverse transcription PCR test detects SARS-CoV-2, the virus causing COVID-19.

The ViroKey test is conducted through nasopharyngeal and oropharyngeal swabs. The manual version of it enables flexible sample processing and quick adoption of the test by all laboratories with existing ABI 7500 Fast Dx instruments, according to a news release.

Vela also created an automated version of the assay that is optimized for a workflow with the Sentosa SX101 instrument along with the ABI 7500 Fast Dx or the Sentosa SA 201.

ViroKey SARS-CoV-2 RT-PCR also received CE mark and provisional approval from the Singapore Health Sciences Authority, according to Vela.

“RT-PCR is currently the gold stan…

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