QIAGEN NeuMoDx CT/NG Assay cleared by the FDA

QIAGEN has announced that the US Food and Drug Administration (FDA) has given clearance for the NeuMoDx CT/NG Assay 2.0, growing QIAGEN's 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) – the most common type of bacterial infection among sexually transmitted infections (STIs), according to the US National Institutes of Health. The majority of these infections are asymptomatic and generally curable with existing single-dose regimens of antibiotics. However, the time it takes for results to be received is often long, impeding follow-up care.

This FDA clearance supports the test menu expansion for NeuMoDx Molecular Systems in the US. 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. These capabilities dramatically improve lab productivity and the ability to provide clinicians with critical information in a timely manner.

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