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Qiagen Gets CE Mark for Molecular Multiplex Respiratory Pathogen Assay

NEW YORK – Qiagen said on Tuesday that it has garnered CE marking for the QiaStat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test to identify whether patients have common seasonal respiratory infections or SARS-CoV-2.

Concurrently, Qiagen has launched the test in territories recognizing the CE mark. The multiplex, cartridge-based, RT-PCR assay runs on the sample-to-answer QiaStat-Dx system and can detect and differentiate between influenza A and B, RSV, and SARS-CoV-2 infections. The assay can provide results in about one hour, Qiagen said.

"The COVID-19 pandemic has highlighted the indisputable need for accurate, reliable, and time-sensitive diagnostics," Amy Fox, a clinical virologist and vice chair for clinical research in the Department of Pathology at Montefiore Medical Center, said in a statement.

"The ability to provide rapid and accurate diagnosis through syndromic testing with multiplex PCR has significantly changed the way infectious disease clinicians and laboratorians manage patients and optimize workflow," Fox added. "An accurate early diagnosis may allow for informed, earlier, and more precise therapeutic decisions, and may aid in the implementation of public health measures such as isolation or contact precautions."

"This new test expands the capabilities of our QiaStat-Dx system with a much-needed COVID-19 application that differentiates between respiratory infections quickly without lab infrastructure," Jean-Pascal Viola, senior VP and head of molecular diagnostics and corporate business development at Qiagen, said in a statement.

The QiaStat-Dx system was introduced in Europe in 2018 after receiving CE marking and in the US in mid-2019 after being cleared by the Food and Drug Administration. Besides the new test, its menu currently includes the QiaStat-Dx Respiratory+ test, which detects and differentiates more than 20 respiratory targets including SARS-CoV-2, and the QiaStat-Dx Gastrointestinal test. As of the first half of 2021, Qiagen had more than 2,400 QiaStat-Dx instruments in the market worldwide.