CirrusDx Receives Emergency Use Authorization for COVID-19 Testing

Cirrus Dx received Emergency Use Authorization (EUA) from the US Food & Drug Administration (FDA) to perform SARS-COVID-19 testing.

CirrusDx validated and will commercialize the Allplex™ 2019-nCoV Assay, a real-time Reverse Transcriptase PCR test developed by Seegene, a South Korea-based company involved in multiplex molecular diagnostics. The Seegene test can simultaneously detect three different genes (N, E and RdRP) of SARS-CoV-2, the virus responsible for COVID-19.

"As an infectious disease laboratory in the Washington D.C. area, there is a responsibility to serve the community at large," said Kyle Armantrout, Managing Director at CirrusDx. "Partnering with Seegene to bring Allplex™ 2019-nCoV Assay to high risk communities such as long-term care centers, and healthcare providers on the front lines, is mission critical for our organizations."

The Allplex™ 2019-nCoV Assay test will be performed in the CirrusDx CLIA High Complexity Laboratory with results reporting to clinicians within 24 hours of sample receipt.
 

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