QIAGEN receives FDA clearance of NeuMoDx CT/NG Assay for use on both NeuMoDx 96 and 288 Molecular Systems

Original from: Qiagen

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today 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) – the most common type of bacterial infection among sexually transmitted infections (STIs), according to the U.S. 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 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.

“Ensuring rapid and accurate diagnosis of STIs is an important medical need that QIAGEN is helping to address with the clearance of this NeuMoDx assay in the U.S.,” said Fernando Beils, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. “It also marks an important milestone with the first FDA clearance of a NeuMoDx assay for use on both systems, and this will be an important differentiator in building out the menu in the U.S. to complement the broad menu offered in Europe and other countries.”

The NeuMoDx 96 and 288 Molecular Systems are fully automated, continuous random-access analysers 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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Source: QIAGEN receives FDA clearance of NeuMoDx CT/NG Assay for use on both NeuMoDx 96 and 288 Molecular Systems