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Qiagen Obtains CE Mark for Multiplex Respiratory Infection Test, Saliva-Based SARS-CoV-2 Assay

NEW YORK – Qiagen said on Monday that it has obtained CE IVD marking for its NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test to help healthcare professionals identify and differentiate between patients with common seasonal respiratory infections and COVID-19.

The test is now available in the European Union and other markets recognizing CE-IVD marking. Qiagen has also submitted the test to the US Food and Drug Administration for Emergency Use Authorization.

The new multiplex PCR test detects and differentiates influenza A and B, respiratory syncytial virus, and SARS-CoV-2 infections from nasopharyngeal swab samples within 80 minutes. The assay runs on the NeuMoDx 96 and NeuMoDx 288 fully automated testing systems, which also feature high-throughput testing capacity, true random access, and continuous loading of samples, reagents, and consumables.

Qiagen also said that it has expanded the specimen types that can be used with the previously CE-marked NeuMoDx SARS-CoV-2 test by obtaining CE IVD marking for testing of saliva samples using the NeuMoDx Saliva Collection Kit. This test also received FDA EUA in March, and Qiagen said on Monday that a claim extension for the saliva collection kit is also currently in review with FDA.

Qiagen fully acquired NeuMoDx in September, and the companies have worked together to launch assays for several other infectious diseases on the company's diagnostic testing platform this year.