QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its NeuMoDx™ HAdV Quant Assay for the identification and quantification of human adenovirus (HAdV) DNA has received CE-IVD certification for the European Union and other countries that accept this marking.
This milestone marks the 15th assay available on the NeuMoDx™ 96 and 288 Molecular Systems, which is considered one of the broadest menus available among competitors. The tests can be run in true random access along with Laboratory Developed Tests (LDTs). Additional assays planned for CE-IVD launch in 2021 include Herpes Simplex Virus (HSV I/II), Human Herpesvirus 6 (HHV-6) as well as an FDA submission for Chlamydia & Gonorrhea (CT/NG).
Testing for the human adenovirus is critical since it can cause severe respiratory and other diseases in patients with weakened immune systems, a common consequence of organ transplantation.
The new HAdV Quant Assay was developed in partnership with Sentinel Diagnostics, an IVD company engaged in the development and production of diagnostic kits for Clinical Chemistry, Immunochemistry and Molecular Diagnostics. The availability of the HAdV assay strengthens the current NeuMoDx transplant assay menu that already includes CE-marked tests for cytomegalovirus (CMV), Epstein–Barr virus (EBV) and BK Virus (BKV) viral load monitoring for the management of immunocompromised patients, such as those who have undergone organ transplantation.
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 HAdV genome.
The NeuMoDx solutions currently offer CE-IVD tests for various viral and bacterial pathogens. Aside from assays 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, there are tests for blood-borne viruses and post-transplant monitoring for CMV, EBV and BKV. The menu also features assays covering sexual and reproductive health including HPV and Chlamydia trachomatis.
Source: Company Press Release
