QIAGEN: NeuMoDx Multiplex Test Gets FDA Emergency Use Authorization To Differentiate COVID-19

Qiagen N.V. (QGEN) announced Monday that the U.S. Food and Drug Administration or FDA has granted Emergency Use Authorization for the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test.

The polymerase chain reaction or PCR multiplex test will help healthcare professionals quickly identify and differentiate individuals suspected by a healthcare provider of respiratory viral infection consistent with COVID-19.

According to the company, the 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 or RSV and SARS-CoV-2 infections within 80 minutes.

The company projects growth in respiratory viral infections as restrictions are eased and social distancing measures are reduced. 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.

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. It will now begin commercialization of the test in the U.S.

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