QIAGEN announced the U.S. Food and Drug Administration (FDA) clearance for the NeuMoDx CT/NG Assay 2.0, growing its test menu for its integrated PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in the United States.
This assay is designed for direct detection of asymptomatic and symptomatic bacterial infections involving Chlamydia trachomatis (CT) and / or Neisseria gonorrhoeae (NG).
This FDA clearance supports the test menu expansion for NeuMoDx Molecular Systems in the U.S. It also builds on the 16 EU-certified in-vitro diagnostics (CE-IVD) tests available on these systems, which is one of the broadest on the market in countries accepting CE-IVD markings, including assays for transplant-associated viruses, respiratory infections, blood-borne viruses, and sexual and reproductive health.
The NeuMoDx 96 and 288 Molecular Systems are fully automated, continuous random-access analyzers that deliver results in just about an hour. The systems extract DNA to isolate the target nucleic acids and then conduct a real-time polymerase chain reaction (RT-PCR). Room-temperature stable reagents and consumables dramatically reduce waste. Based on microfluidic cartridges, they allow running of 12 reactions at once and up to eight hours of operator walkaway capability.