QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) has announced the clearance from the U.S. Food and Drug Administration (FDA) for the NeuMoDx CT/NG Assay 2.0, expanding its test menu for its integrated PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in the United States.
This test is designed for the direct detection of asymptomatic and symptomatic bacterial infections Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) – reported by the U.S National Institutes of Health as the most common bacterial infection among sexually transmitted infections (STIs). Most of these infections are asymptomatic and are generally curable with existing single-dose antibiotic therapies. However, obtaining results can often take a long time, complicating follow-up care.
This FDA clearance supports the expansion of the test menu for NeuMoDx Molecular Systems in the U.S. It also builds on the 16 European Union-certified in vitro diagnostic tests (CE-IVD) available on these systems, which are among the most comprehensive in individual countries, accepting CE-IVD markings, including tests for transplant-associated viruses, respiratory infections, blood-borne viruses, as well as sexual and reproductive health.
“Ensuring fast and accurate diagnosis of STIs is an important medical need that QIAGEN is addressing with the clearance of this NeuMoDx test in the U.S.,” said Fernando Beils, Senior Vice President and Head of Molecular Diagnostics at QIAGEN. “The first FDA clearance of a NeuMoDx assay for use on both systems also represents an important milestone, and this will be a key differentiator in building the menu in the U.S. to complement the broad menu in Europe and other countries.”
The NeuMoDx 96 and 288 molecular systems are fully automated analysis devices with continuous direct access, delivering results in about an hour. The systems extract DNA to isolate the target nucleic acids and then perform real-time polymerase chain reaction (RT-PCR). Reagents and consumables stable at room temperature significantly reduce waste. They are based on microfluidic cartridges, allowing for the simultaneous performance of 12 reactions and a walkaway function for the operator for up to eight hours. These features substantially enhance laboratory productivity and the ability to promptly provide physicians with crucial information.
For more information on the NeuMoDx assay menu, visit https://go.qiagen.com/neumodx