Rhoenix gets emergency clearance for COVID-19 assay

Updated Apr 30, 2020
2019 05 28 19 27 1157 Approved Stamp 400

The U.S. Food and Drug Administration (FDA) has granted molecular testing company Rhoenix emergency use authorization for a fully automated test to detect the presence of the novel coronavirus from respiratory samples.

The Rheonix COVID-19 MDx assay provides same-day results for COVID-19 testing, according to the company. The automated workflow doesn't need the assistance of a technician and can be done on-site at distributed locations.

The assay is designed for small- and medium-throughput laboratories and is compatible with the company's Encompass MDx workstation. Rheonix said that it has begun shipping both the workstation and test kits to hospital laboratories.

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