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Qiagen Nabs CE Mark for High-Throughput SARS-CoV-2 Test Kit

NEW YORK – Qiagen said on Tuesday that it has received a CE-IVD mark for its Artus SARS-CoV-2 Prep&Amp UM Kit for high-throughput PCR-based COVID-19 testing.

The kit is now commercially available in the EU and other markets accepting the CE-IVD mark, and Qiagen has submitted an Emergency Use Authorization application for the assay to the US Food and Drug Administration.

The kit uses the same technology as the research-use-only QIAprep&amp viral RNA UM Kit that the company launched in October, and features a liquid-based sample preparation step that the company said takes no more than two minutes with the provided real-time PCR assay. It uses common transport media, such as universal transport media, as the starting material and includes all testing reagents, yielding results more quickly than standard extraction-based real-time PCR workflows and supporting up to 672 samples per cycler in an eight-hour shift, Qiagen said.

Total time to result is less than an hour, and the kit is compatible with the Qiagen RGQ MDx and Thermo Fisher Scientific ABI 7500 Dx real-time PCR systems.

"We continue to see the need for a large volume of PCR tests as COVID-19 cases continue around the world — and our novel technology will enable clinical labs to drastically increase testing capacity with existing infrastructure," Jean-Pascal Viola, senior VP and head of molecular diagnostics and corporate business development at Qiagen, said in a statement. "It is also an exciting and versatile technology with additional potential applications."