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Vela Diagnostics Automated Coronavirus Test Gets CE-IVD Mark

NEW YORK — Vela Diagnostics said on Monday that an automated version of its ViroKey SARS-CoV-2 RT-PCR Test has received CE-IVD marking, as well as provisional authorization from Singapore's Health Sciences Authority.

The test detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 ORF1a and N genes. It runs on the Singapore-based company's Sentosa SX101 instrument, in conjunction with its Sentosa SA201 instrument or Thermo Fisher Scientific's ABI 7500 Fast Dx and can perform up to 48 tests on a single run.

A nonautomated version of the test received CE-IVD marking in April. Vela developed both tests with $225,000 in Biomedical Advanced Research and Development Authority funding.

The Scan

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