QIAGEN Launches NeuMoDx Multiplex Test to Complete Range of SARS-CoV-2 Testing Solutions in Europe and Other Markets

Rhea-AI Summary

QIAGEN N.V. (NYSE: QGEN) has launched the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test in Europe, addressing the need for rapid diagnosis during flu season. This multiplex PCR test can differentiate between influenza A and B, RSV, and SARS-CoV-2 in just 80 minutes, aiding healthcare professionals in treatment decisions amidst similar respiratory symptoms. Following CE-IVD registration, the test has also received a request for Emergency Use Authorization from the FDA. The company has additionally expanded the use of saliva samples in its existing SARS-CoV-2 test.

Positive

• Launch of NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test in Europe, enhancing diagnostic capabilities.
• Test provides results in 80 minutes, facilitating timely patient management during flu season and COVID-19.
• Emergency Use Authorization request submitted to the FDA, potentially increasing market reach.

Negative

• None.

GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today 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.

Please find the full press release here

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