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Qiagen Obtains CE-IVD Mark on NeuMoDx Epstein-Barr Virus, Human Herpesvirus-6 Tests

NEW YORK – Qiagen announced on Thursday that it has obtained the CE-IVD mark for RT-PCR assays to detect and quantify Epstein-Barr virus and human herpesvirus-6 on its NeuMoDx instruments. They are now available in the EU and countries that accept the CE marking for the NeuMoDx 96 and 288 automated molecular systems.

The EBV and HHV-6 tests are used for viral load monitoring for the management of immunocompromised people, such as organ transplant patients.

The NeuMoDx systems use microfluidic cartridges and provide results in one hour, with up to eight hours of walkaway time, Qiagen said in a statement. The two new tests expand the CE-IVD menu on the NeuMoDx systems to 16 assays, the firm further noted.

Qiagen is also developing an improved multiplex assay for influenza A and B, respiratory syncytial virus, and SARS-CoV-2 that will use a new dual-target SARS-CoV-2 design, as well as a multiplex research-use assay for the detection of monkeypox to be made available later this year.