Qiagen's QIAstat-Dx Meningitis/encephalitis Panel Gets FDA Clearance For Emergency Diagnostics

(RTTNews) - Qiagen N.V. (QGEN) announced Monday that the U.S. Food and Drug Administration has cleared the QIAstat-Dx Meningitis/Encephalitis Panel for use in clinical settings to help diagnose central nervous system infections.

Meningitis (inflammation of the membrane surrounding the brain and spinal cord) and encephalitis (inflammation within the brain) are medical emergencies that require immediate treatment.

QIAstat-Dx delivers results in about one hour with real-time PCR, for fast and accurate results to support clinical decision-making.

Qiagen noted that the Panel leverages the system's ability to quickly amplify many genetic targets at the same time using real-time PCR technology. The QIAstat-Dx panel simultaneously analyzes several of the most common viral, bacterial and fungal pathogens responsible for community-acquired meningitis/encephalitis.

Bacterial meningitis cases in the U.S. have reached their highest levels since 2014, it said.

Fernando Beils, Senior Vice President and Head of the Molecular Diagnostics Business Area at QIAGEN, said, "Community-acquired meningitis and encephalitis can progress rapidly, and that means healthcare providers need evidence-based diagnostics that can help them make rapid treatment decisions. The QIAstat-Dx Meningitis/Encephalitis Panel addresses many challenges faced by clinicians and streamlines the process so they can get timely and accurate results in about one hour."

The new panel marks the fourth FDA clearance of a QIAstat-Dx panel in 2024. All QIAstat-Dx panels are available as cost-efficient, single-use cartridges that slot easily into the QIAstat-Dx instrument.

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