The test is capable of differentiating the influenza virus A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes
Qiagen has launched its NeuMoDx Flu A-B/RSV/SARS-CoV-2 vantage test for rapid identification and differentiation between common seasonal flu and Covid-19 in Europe.
The molecular diagnostics firm claimed that its multiplex polymerase chain reaction (PCR) test is capable of detecting and differentiating the influenza virus A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes.
The new respiratory test is designed based on the automated three-step workflow of NeuMoDx 96 and NeuMoDx 288 molecular systems, originally developed by molecular diagnostics company NeuMoDx Molecular.
In September 2020, Qiagen has completed the takeover of the NeuMoDx Molecular for $248m in cash, following the purchase of initial 19.9% stake in 2018, for $234m.
NeuMoDx 288 and NeuMoDx 96 are rapid, integrated PCR-based devices, designed to provide thirteen CE-IVD-marked assays for different infectious diseases in Europe.
As the viruses produce similar respiratory symptoms, differential diagnosis among them is important for treatment of patients and decisions management amid the Covid-19 pandemic.
Qiagen seeking EUA for the multiplex test in US
Following the CE-IVD registration, Qiagen has launched its NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage in the European and other markets. It also filed an application with FDA for Emergency Use Authorization (EUA) of the test.
The CE-IVD approval expanded the sample type claim for NeuMoDx SARS-CoV-2 test in Europe, to include saliva from a dedicated collection kit, which includes a collection vial, stabilisation tube and pipette.
With additional features including processing capacity, true random access, and continuous loading of samples, reagents and consumables, the test offers a strong diagnostic tool for the flu season and Covid-19 pandemic, said the company.
In August 2020, medical technology firm Thermo Fisher Scientific terminated its agreement to acquire Qiagen.