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Qiagen NeuMoDx Human Adenovirus Assay Receives CE Mark

NEW YORK – Qiagen said on Thursday that its NeuMoDx HAdV Quant Assay for the identification and quantification of human adenovirus DNA has received CE-IVD certification.

Qiagen developed the assay in partnership with Sentinel Diagnostics, and the test adds to the current NeuMoDx transplant assay menu that already includes CE-marked tests for cytomegalovirus, Epstein-Barr virus, and BK virus viral load monitoring for the management of immunocompromised patients, such as those who have undergone organ transplantation.

All of these assays use Qiagen's automated, three-step NeuMoDx workflow that extracts DNA from blood or urine to isolate target nucleic acids followed by real-time PCR to target conserved sequences in the genomes of target viruses.

The new assay is also the 15th overall available on the NeuMoDx 96 and 288 Molecular Systems, which enables true random access of Qiagen-developed tests as well as laboratory-developed tests.

Qiagen acquired the remaining stake in NeuMoDx in September 2020 after having acquired a minority stake in the Ann Arbor, Michigan-based diagnostic developer in 2018 as part of a test menu development deal.