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Qiagen Receives FDA Emergency Use Authorization for SARS-CoV-2 Respiratory Panel

NEW YORK – Qiagen late on Monday received Emergency Use Authorization from the US Food and Drug Administration for the QiaStat-Dx Respiratory SARS-CoV-2 Panel for use in diagnosing patients infected with the coronavirus causing COVID-19.

The panel can detect and differentiate SARS-CoV-2 and 20 other viral and bacterial pathogens known to cause serious respiratory disease from nasopharyngeal swabs in symptomatic patients, and will become the first "syndromic" testing product to be deployed in the US.

Specifically, the QIAstat-Dx panel is intended for the detection and differentiation of nucleic acid from SARS-CoV-2 as well as adenovirus; four other coronavirus types; human metapneumovirus A+B; influenzas A, A H1, A H3, A H1N1/pdm09, and B types; parainfluenza viruses 1-4; rhinovirus/enterovirus, respiratory syncytial virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

The multiplex real-time PCR test runs on Qiagen's fully automated, sample-to-answer QiaStat-Dx platform and is designed to provide results from a patient nasopharyngeal swab in about an hour.

The new product is an update of Qiagen's existing QiaStat-Dx Respiratory Panel, which previously received FDA clearance and CE marking. The updated panel includes two molecular targets specific to SARS-CoV-2: the ORF1b gene recommended by the Chinese Center for Disease Control and Prevention, and the N gene recommended by the US Centers for Disease Control and Prevention. The company received $598,000 in funding from the US Department of Health and Human Services Biomedical Advanced Research and Development Authority to help develop the panel.

Qiagen began shipping QiaStat-Dx SARS-CoV-2 kits to the US last week under FDA's revised policy for emergency coronavirus testing. The company said that it has placed more than 200 QiaStat-Dx instruments in the US, and more than 1,100 worldwide. Qiagen also garnered CE mark for the panel earlier this month.

"The QiaStat-Dx syndromic panel adds an important tool for clinicians," Qiagen CEO Thierry Bernard said in a statement. "I am proud of our Qiagen teams working tirelessly to implement 24/7 production of test cartridges and testing components. In addition to QiaStat-Dx, we are supplying RNA extraction kits under the QiaAmp and EZ1 brands as well as numerous components and instruments for use in fighting this public health crisis around the world."

Also on Monday, US firm NeuMoDx received FDA EUA for a COVID-19 assay that runs on the company's fully automated, high-throughput NeuMoDx 288 and NeuMoDx 96 molecular testing systems. In 2018, Qiagen entered into an agreement to acquire NeuMoDx, dependent on company milestones such as test menu development for its platforms in the US. Qiagen itself is now in the process of being acquired by Thermo Fisher Scientific in an $11.5 billion deal.