QIAGEN Granted EUA for its 4-Plex COVID-19 Test

By Michael Barbella, Managing Editor | 05.06.21

The assay can detect and differentiate influenzas A and B, respiratory syncytial virus (RSV), and COVID-19 infections within 80 minutes.

The U.S. Food and Drug Administration (FDA) has granted emergency use authorization to QIAGEN N.V.'s NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, which will help healthcare professionals quickly identify and differentiate COVID-19 infections. 

“The authorization of this new test will become a pivotal tool for the detection and differentiation of SARS-CoV-2 from influenza like illnesses, or ILls,” said Jean-Pascal Viola, senior vice president, head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. “This test will play an important role in differentiating between ILI’s while the burden of COVID-19 continues. With its ease of use and true random access, the NeuMoDx will help laboratories maintain throughput for this increased testing volume while continuing routine testing. Also, with the continued ramp up of our manufacturing capacity, the NeuMoDx will be ready to answer the needs of molecular diagnostic laboratories for 2021 and beyond.”
As restrictions are eased and social distancing measures are reduced, respiratory viral infections are likely to increase. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza or RSV can be similar. This makes it essential to correctly identify them in order to treat and manage patients accordingly, especially in the COVID-19 pandemic. This polymerase chain reaction (PCR) multiplex test will be an important tool now and in upcoming winter seasons for simultaneous qualitative detection and differentiation of influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes.
QIAGEN launched the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test in the European Union and other markets that accept CE-IVD in November 2020 and will now begin commercialization of the test in the United States.
QIAGEN’s new respiratory test takes advantage of the NeuMoDx 96 and NeuMoDx 288 molecular systems’ automated three-step workflow. Coupled with additional system features—like processing capacity, true random access, and continuous loading of samples, reagents and consumables while the system is running—the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay will be a powerful diagnostic tool for the flu season and COVID-19 pandemic.
The new 4-plex test joins a growing menu of assays on the NeuMoDx platform, which includes tests for blood-borne viruses, sexual and reproductive health, transplant and immunocompromised disease areas. More tests are in development and expected to launch in the coming months, including VZV, adenovirus and others.
QIAGEN fully acquired NeuMoDx in September 2020 and made it one of its five growth drivers for the company to continue growing on a standalone basis—the others being Sample Prep, QIAcuity, QFT and QIAstat-Dx. The NeuMoDx Flu A-B/RSV/ SARS-CoV-2 Vantage Test strengthens QIAGEN’s footprint in PCR, the gold standard in coronavirus testing.
QIAGEN has a broad portfolio of testing and research solutions for COVID-19, ranging from fast singleplex and multiplex PCR tests to fast syndromic solutions (QIAstat-Dx), providing customers with a broad variety of PCR-based testing options. Furthermore, the portfolio includes RNA extraction kits and instruments as well as testing components and enzymes used by third parties for their own PCR test kits. QIAGEN’s COVID-19 portfolio also includes the QIAreach Antibody and Antigen tests, as well as SARS-CoV-2 T-Cell tests based on the QuantiFERON IGRA technology. In October 2020, the company also launched QIAprep&amp which streamlines PCR workflows by integrating sample preparation and real-time PCR detection into a single kit. QIAGEN also provides NGS solutions for research into mutations of COVID-19, dPCR solutions for wastewater testing and bioinformatics with QDI.