QIAGEN Wins FDA Clearance of QIAstat-Dx Meningitis/Encephalitis Panel

The U.S. Food and Drug Administration (FDA) has cleared QIAGEN’s QIAstat-Dx Meningitis/Encephalitis Panel for clinical use. It is the fourth QIAstat-Dx syndromic test to receive U.S. regulatory clearance this year.

Meningitis (inflammation of the membrane surrounding the brain and spinal cord) and encephalitis (inflammation within the brain) are medical emergencies that require immediate treatment. One in five cases of bacterial meningitis results in permanent complications such as hearing loss, brain damage, and seizures; without prompt treatment, about half of patients die.¹

U.S. bacterial meningitis cases have reached their highest levels since 2014, with case numbers varying from state to state depending on vaccination rates.²

Many U.S. healthcare facilities still rely solely on traditional microbiological testing, which often requires samples to be incubated for at least 24 hours compared to QIAstat-Dx delivering results in about one hour. Traditional methods also lack sensitivity, which is critical given that only a small amount of cerebrospinal fluid (CSF) is collected from a patient for testing.

“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,” said Fernando Beils, senior vice president and head of the Molecular Diagnostics Business Area at QIAGEN. “This marks the fourth FDA clearance for a QIAstat-Dx test in 2024, and a signal of our commitment to expanding our test menu in the U.S. as well as around the world.”

The QIAstat-Dx Meningitis/Encephalitis 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.

The QIAstat-Dx system is also unique in that results include cycle threshold (Ct) values and amplification curves, which offer immediately viewable information for detected pathogens and provide healthcare professionals with additional clinical information not available with end-point PCR or other techniques.

Other FDA-cleared QIAGEN’s tests include the QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx Respiratory Panel Plus; and QIAstat-Dx Respiratory Panel Mini.

All QIAstat-Dx panels are available as cost-efficient, single-use cartridges that slot easily into the QIAstat-Dx instrument. All reagents are preloaded into the cartridge, enabling the test set-up to be completed in less than a minute and requires no precision pipetting. Software interprets signals from the reaction and provides positive or negative results for each pathogen, providing clinicians with a simple syndromic testing workflow.

Netherlands-based QIAGEN N.V. provides sample to insight solutions that enable customers to gain valuable molecular insights from samples containing life’s building blocks. Its sample technologies isolate and process DNA, RNA and proteins from blood, tissue, and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers worldwide in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2024, QIAGEN employed more than 5,900 people in over 35 locations worldwide.

References
¹ https://www.who.int/news-room/fact-sheets/detail/meningitis, as of October 30, 2024
² https://www.cdc.gov/meningococcal/php/surveillance/index.html, as of October 30, 2024