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Qiagen Obtains CE Mark for Molecular HSV Test on NeuMoDx Platforms

NEW YORK – Qiagen said on Thursday that it has received CE-IVD certification for its NeuMoDx HSV 1/2 Quant Assay on the NeuMoDx 96 and 288 Molecular Systems. 

The assay is intended for the quantification and differentiation of herpes simplex virus 1 (HSV-1) and HSV-2 DNA, and makes use of Qiagen’s automated NeuMoDx technology that extracts and isolates DNA from blood or urine and conducts real-time PCR to target conserved sequences in the HSV genome. 

Following CE marking of this assay, Qiagen now offers 15 CE-IVD tests for the NeuMoDx systems. The new assay bolsters the company's organ transplant diagnostic menu, which also includes assays for cytomegalovirus, Epstein-Barr virus, BK virus, and human adenovirus viral load monitoring. 

Qiagen said it developed the HSV assay in partnership with Italy's Sentinel Diagnostics.