CirrusDx Laboratory receives emergency use authorisation from FDA for 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 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 Allplex™ 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.

“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.

Seegene is the world’s leading developer of multiplex molecular technologies and multiplex clinical molecular diagnostics. Seegene’s core enabling technologies (DPO™, TOCE™, and MuDT™) 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. Seegene’s products and automation offer unparalleled throughput and cost savings. Seegene’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.