Skip to main content
Premium Trial:

Request an Annual Quote

FDA Clears Qiagen's HSV-1/2 MDx Kit

NEW YORK(GenomeWeb) – Qiagen said after the close of the market on Thursday that the US Food and Drug Administration cleared the artus HSV-1/2 QS-RGQ kit for molecular diagnosis of herpes simplex virus type 1 and type 2 infections.

FDA cleared the HSV-1/2 kit in late December to run on the QIAsymphony RGQ molecular diagnostics system. Qiagen said the assay was its fifth in 2014 to receive FDA clearance or approval.

The test is PCR-based with sample processing and assay setup through the QIAsymphony SP and QIAsymphony AS modules. Both HSV-1 and HSV-2 are widespread, Qiagen said, with HSV-1 often manifesting in oral infections and HSV-2 associated with genital infections.

The company also said that it surpassed its goal of 250 new placements of the QIAsymphony platforms in 2014, and that the total number of cumulative placements as of the end of the year exceeded 1,250. For 2015, Qiagen reaffirmed its goal of 250 new system placements for a total cumulative placement of more than 1,500.