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CirrusDx Laboratory receives emergency use authorisation from FDA for COVID-19 testing

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CirrusDx validated and will commercialize the Allplex 2019-nCoV Assay, a real-time Reverse Transcriptase PCR test developed by Seegene, a South Korea-based global leader in multiplex molecular diagnostics.

Cirrus Dx, an infectious disease laboratory and diagnostics company, received Emergency Use Authorization (EUA) from the US Food & Drug Administration (FDA) to perform SARS-COVID-19 testing.

CirrusDx validated and will commercialize the Allplexโ„ข 2019-nCoV Assay, a real-time Reverse Transcriptase PCR test developed by Seegene, a South Korea-based global leader 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.

โ€œAs an infectious disease laboratory in the Washington D.C. area, there is a responsibility to serve the community at large,โ€ said Kyle Armantrout, Managing Director at CirrusDx. โ€œPartnering with Seegene to bring Allplexโ„ข 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.โ€

The Allplexโ„ข 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.

Seegene is the worldโ€™s leading developer of multiplex molecular technologies and multiplex clinical molecular diagnostics. Seegeneโ€™s core enabling technologies (DPOโ„ข, TOCEโ„ข, and MuDTโ„ข) form the foundation for its expansive portfolio of test panels that can simultaneously detect multiple targets in a single tube with high sensitivity, specificity and reproducibility. Seegeneโ€™s products and automation offer unparalleled throughput and cost savings. Seegeneโ€™s mission is to maintain leadership in molecular diagnostics for infectious diseases, genetics, pharmacogenetics and oncology through its innovative proprietary technologies and AI-based assay design.

CirrusDx operates as a vertically integrated diagnostic company comprised of a CLIA High Complexity laboratory offering advanced diagnostics assays and diagnostics instrumentation.

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