QIAGEN receives FDA Emergency Use Authorization for NeuMoDx test, expanding COVID-19 portfolio
High-throughput Testing
QIAGEN’s NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage test has received Emergency Use Authorization from the US Food & Drug Administration (FDA). The four-plex test uses the high-throughput, automated testing capabilities of the NeuMoDx systems, which has a growing and comprehensive assay menu for respiratory, blood-borne virus, transplant and reproductive health disease areas. The assay will help healthcare professionals quickly identify and differentiate individuals suspected by a healthcare provider of respiratory viral infection consistent with COVID-19, according to QIAGEN.
When restrictions are eased and social distancing measures are reduced, respiratory viral infections are likely to increase. Clinical signs and symptoms of respiratory viral infection from 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. QIAGEN believes that 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’s new respiratory test takes advantage of the NeuMoDx 96 and NeuMoDx 288 molecular systems’ automated three-step workflow. Coupled with additional system features, such as 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 could be a powerful diagnostic tool for the flu season and COVID-19 pandemic.
According to Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN, “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. 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.”
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. More tests are in development and expected to launch in the coming months, including VZV, adenovirus and others.
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), giving customers 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. 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.