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Vela Diagnostics Receives Second FDA Emergency Use Authorization for SARS-CoV-2 Molecular Test

NEW YORK ─ Vela Diagnostics said on Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration for its ViroKey SARS-CoV-2 RT-PCR Test v2.0.

The automated probe-based RT-PCR test detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs and is optimized for a workflow consisting of Vela Diagnostics' Sentosa SX101 and Sentosa SA201 instruments. The test enables high-throughput testing of up to 46 samples in a single run with reduced hands-on time, Vela said.

In August, the Singapore-based company received FDA EUA for a manual version of the ViroKey SARS-CoV-2 RT-PCR Test.

Rachel Yap, product manager at Vela, said in an email that the new test is multiplexed, targeting the virus' ORF1a and N genes, and has a better limit of detection than the manual version, in addition to providing automated analysis and reporting of results.

The firm said it has also received provisional authorization for use of the test from the Singapore Health Sciences Authority.

In July, Vela announced it had received CE marking for the automated test. In April, it received CE marking for the nonautomated version.