Product News: QIAGEN launches NeuMoDx multiplex test to complete range of SARS-CoV-2 testing solutions in Europe and other markets

QIAGEN N.V. has announced the European launch of the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test that will help healthcare professionals quickly identify and differentiate between patients with common seasonal respiratory infections and COVID-19.

With the Northern Hemisphere in the grip of flu season, this multiplex polymerase chain reaction (PCR) test detects and differentiates influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes. These viruses produce similar respiratory symptoms, making it essential to provide differential diagnosis among them for patient treatment and management decisions, especially in the COVID-19 pandemic.

QIAGEN has launched NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage in the European Union and other markets after CE-IVD registration, and has submitted an Emergency Use Authorization (EUA) request to the FDA.

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 test will be a powerful diagnostic tool for the flu season and COVID-19 pandemic.

In addition, QIAGEN has expanded specimen types that can be used on the existing NeuMoDx™ SARS-CoV-2 test. CE-IVD approval has been obtained for the use of saliva samples collected with the NeuMoDx™ Saliva Collection Kit, which includes a collection vial, stabilization tube and pipette.

This kit allows for less invasive sample collection compared to commonly used nasal swabs. It reduces the burden on the supply of the nasal collection devices and increases laboratory testing capacity. This claim extension for the saliva collection kit is also in review with the FDA. The singleplex test was granted an EUA in March.

“Both launch and label extension expand the capabilities of our NeuMoDx systems in detection of COVID-19,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “They add to our growing NeuMoDx testing menu, which in 2020 included launches for HIV-1, TV/MG, Strep A/C/G, HPV, BK virus, and Influenza A-B/RSV. We will launch additional assays in 2021 and continue to increase the value of the platform for lab customers beyond the pandemic.

QIAGEN fully acquired NeuMoDx in September and made it one of its five growth drivers that make the company strong enough to continue to grow on a standalone basis – the others being Sample Prep, QIAcuity, QFT and the QIAstat-Dx. The NeuMoDx™ Flu A-B/RSV/ SARS-CoV-2 Vantage Assay strengthens QIAGEN’s footprint in PCR, the gold standard in coronavirus testing.  

QIAGEN now is the only company to be able to offer fast singleplex and multiplex PCR tests as well as a fast syndromic solution (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. In October, QIAGEN also launched QIAprep& which streamlines PCR workflows by integrating sample preparation and real-time PCR detection into a single kit. The product has initially been launched for research use only and is planned to gain EUA and CE-IVD registration soon.

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