QIAGEN receives FDA clearance of QIAstat-Dx meningitis/encephalitis panel to support emergency diagnostics

Original from: QIAGEN

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Meningitis/Encephalitis Panel for clinical use.

This marks the fourth QIAstat-Dx syndromic test to receive U.S. regulatory clearance in 2024. 

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 and without prompt treatment, about half of patients will die.

Bacterial meningitis cases in the United States have reached their highest levels since 2014, with case numbers varying from state to state depending on vaccination rates.

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.

This new panel marks the fourth FDA clearance of a QIAstat-Dx panel in 2024, and comes after the recent FDA clearances for other tests: 

QIAstat-Dx Gastrointestinal Panel 2

QIAstat-Dx Respiratory Panel Plus 

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 one of the simplest workflows for syndromic testing on the market.

Source: QIAGEN receives FDA clearance of QIAstat-Dx meningitis/encephalitis panel to support emergency diagnostics