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 standard for diagnosing SARS-CoV-2 infections,” Vela interim CEO & chairman of the board Sam Dajani said in the release. “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. Our coronavirus test will assist healthcare professionals in managing the COVID-19 pandemic.”