QIAGEN (NYSE: QGEN; Frankfurt Prime Customary: QIA) at this time introduced the U.S. Meals and Drug Administration (FDA) clearance for the NeuMoDx CT/NG Assay 2.0, rising its check menu for its built-in PCR-based scientific molecular testing methods NeuMoDx 96 and 288 in america.

This assay is designed for direct detection of asymptomatic and symptomatic bacterial infections involving Chlamydia trachomatis (CT) and / or Neisseria gonorrhoeae (NG) – the most typical sort of bacterial an infection amongst sexually transmitted infections (STIs), in line with the U.S. Nationwide Institutes of Well being. The vast majority of these infections are asymptomatic and customarily curable with current single-dose regimens of antibiotics. Nonetheless, the time it takes for outcomes to be acquired is usually lengthy, impeding follow-up care.

This FDA clearance helps the check menu enlargement for NeuMoDx Molecular Programs within the U.S. It additionally builds on the 16 EU-certified in-vitro diagnostics (CE-IVD) assessments obtainable on these methods, which is among the broadest in the marketplace in nations accepting CE-IVD markings, together with assays for transplant-associated viruses, respiratory infections, blood-borne viruses, and sexual and reproductive well being.

“Guaranteeing fast and correct prognosis of STIs is a crucial medical want that QIAGEN helps to handle with the clearance of this NeuMoDx assay within the U.S.,” stated Fernando Beils, Senior Vice President, Head of the Molecular Diagnostics Enterprise Space at QIAGEN. “It additionally marks an vital milestone with the primary FDA clearance of a NeuMoDx assay to be used on each methods, and this shall be an vital differentiator in constructing out the menu within the U.S. to enrich the broad menu supplied in Europe and different nations.”

The NeuMoDx 96 and 288 Molecular Programs are absolutely automated, steady random-access analysers that ship ends in nearly an hour. The methods extract DNA to isolate the goal nucleic acids after which conduct a real-time polymerase chain response (RT-PCR). Room-temperature steady reagents and consumables dramatically cut back waste. Primarily based on microfluidic cartridges, they permit operating of 12 reactions directly and as much as eight hours of operator walkaway functionality. These capabilities dramatically enhance lab productiveness and the flexibility to supply clinicians with vital data in a well timed method.

For extra details about the NeuMoDx assay menu, please go to https://go.qiagen.com/neumodx