QIAGEN now offering 15 CE-IVD assays for use on NeuMoDx™ 96 and 288 systems in addition to capabilities to process laboratory-developed tests (LDT)
QIAGEN Adds HSV1/2 Herpes Assay on NeuMoDx Integrated PCR System. (Credit: Louis Reed on Unsplash)
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its NeuMoDx HSV 1/2 Quant Assay for the quantification and differentiation of herpes simplex virus type 1 (HSV-1) DNA and/or herpes simplex virus type 2 (HSV-2) has received CE-IVD certification for the European Union and other countries that accept this marking.
This approval supports QIAGEN’s strategy to expand the menu of tests available for use on the NeuMoDx 96 and 288 Molecular Systems, which offer one of the broadest menus on the market now with 15 CE-IVD tests available.
The availability of the NeuMoDx HSV 1/2 Quant Assay also strengthens the comprehensive menu of transplant assays. These include CE-marked tests for cytomegalovirus (CMV), Epstein–Barr virus (EBV), BK Virus (BKV), and human adenovirus (hAdV) viral load monitoring for the management of immunocompromised patients such as organ transplant patients.
Additional assays planned for CE-IVD launch in 2022 include human herpesvirus 6 (HHV-6), and reformulated assays for Epstein-Barr virus (EBV) and combined respiratory panel test that can detect Influenza A / Influenza B / Respiratory Syncytial Virus (RSV) / SARS-CoV-2 virus.
Despite major advances in organ transplantation over the past four decades, herpesvirus infections remain a major cause of post-operative mortality. Testing for HSV-1/2 infections is especially critical in transplant recipients with weakened immune systems.
The new HSV 1/2 Quant Assay was developed in partnership with Sentinel Diagnostics, a company engaged in the development and production of In Vitro Diagnostic kits for clinical chemistry, immunochemistry and molecular diagnostic platforms.
All of these assays make use of QIAGEN’s automated, three-step NeuMoDx solutions that extract DNA from blood or urine to isolate the target nucleic acids and then conduct a real-time polymerase chain reaction (RT-PCR) to target conserved sequences in the HSV genome.
Aside from assays for post-transplant monitoring the NeuMoDx solutions currently offer CE-IVD tests for detection and quantitation of blood-borne viruses (HIV, HCV, and HBV). The menu also features assays for various viral and bacterial pathogens for respiratory infections from SARS-CoV-2 to the 4-Plex test for influenza A and B, RSV and SARS-CoV-2 covering the most common respiratory pathogens, and sexual and reproductive health including HPV and Chlamydia trachomatis.
Source: Company Press Release