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Vela Diagnostics, Capstone Healthcare Get FDA Emergency Use Authorization for Coronavirus Tests

The story has been corrected to say that Vela's ViroKey SARS-CoV-2 RT-PCR Test detects the SARS-CoV-2 ORF1a and RdRp genes, not the N gene, as previously stated.

NEW YORK — Vela Diagnostics and Capstone Healthcare this week received Emergency Use Authorization from the US Food and Drug Administration for their PCR-based SARS-CoV-2 tests.

Vela's test is the manual version of its ViroKey SARS-CoV-2 RT-PCR Test, which is designed to detect the SARS-CoV-2 ORF1a and RdRp genes in nasopharyngeal and oropharyngeal swabs. It runs on Thermo Fisher Scientific's Applied Biosystems 7500 Fast Dx instrument and can be performed by any certified laboratory, the company said.

Singapore-based Vela has also developed an automated version of the test — which runs on its Sentosa SX101 instrument, in conjunction with its Sentosa SA201 instrument or the Applied Biosystems 7500 Fast Dx instrument — that received CE marking and provisional authorization from Singapore's Health Sciences Authority in July. The manual version of the test received CE-IVD marking in April.

Both versions of the test were developed with funding from the Biomedical Advanced Research and Development Authority. 

Capstone's Genus SARS-CoV-2 is designed to detect the virus' N gene in nasopharyngeal and oropharyngeal swabs. Nucleic acid extraction is performed either manually or with Thermo Fisher's KingFisher Flex instrument, and the test runs on the Applied Biosystems QuantStudio 12K Flex instrument.

The test may only be performed by Sandy Springs, Georgia-based Capstone, according to the FDA.

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