FDA clears Qiagen panel for meningitis, encephalitis
Key takeaways:
- The real-time PCR test targets eight pathogens and can return results in about an hour.
- Meningococcal disease infection and fatality rates have increased significantly this year.
The FDA on Monday cleared Qiagen’s 1-hour PCR test for meningitis and encephalitis, which the company said could help treat meningococcal disease more quickly.
The QIAstat-Dx platform was already cleared for multiple gastrointestinal and respiratory panels. The meningitis and encephalitis panel can test for multiple pathogens at a time and deliver results in about 1 hour, according to Qiagen.
The clearance comes as meningococcal disease is on the rise in the United States. Cases last year reached a level not seen in a decade, according to the CDC.
“Community-acquired meningitis and encephalitis can progress rapidly, and that means health care providers need evidence-based diagnostics that can help them make rapid treatment decisions,” Fernando Beils, senior vice president at Qiagen, said in a press release. “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 panel is a multiplexed nucleic acid real-time PCR test that can detect nucleic acid target sequences for enterovirus, Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis (encapsulated), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes and Cryptococcus neoformans/gattii, according to the FDA.
Qiagen has focused on the speed of the test because many health care facilities use traditional testing, which requires samples to be incubated for at least 24 hours.
Healio | Infectious Disease News Editorial Board Member William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, told Healio in April that the uptick in U.S. cases could be caused by diagnostic delays.
“Patients with meningococcal disease, as every doctor is taught in medical school, must be diagnosed early,” Schaffner said. “The disease can manifest principally in two ways — central nervous system infection, or meningitis, an inflammation of the membranes that surround the brain and spinal cord; and through bloodstream infections. Both of these infections can move very rapidly from early symptoms into very severe illness.”
References:
- Cases of meningococcal disease are increasing in the United States. https://www.cdc.gov/ncird/whats-new/meningococcal-disease-cases-increasing-us.html. Updated April 16, 2024. Accessed Nov. 4, 2024.
- QIAGEN receives FDA clearance of QIA-stat-Dx meningitis/encephalitis panel to support emergency diagnosis. https://corporate.qiagen.com/English/newsroom/press-releases/press-release-details/2024/QIAGEN-receives-FDA-clearance-of-QIAstat-Dx-meningitisencephalitis-panel-to-support-emergency-diagnostics/default.aspx. Published Nov. 4, 2024. Accessed Nov. 4, 2024.
- QIAstat-Dx US: For multiplex syndromic testing applications. https://www.qiagen.com/us/products/diagnostics-and-clinical-research/infectious-disease/qiastat-dx-syndromic-testing/qiastat-dx-na. Accessed Nov. 4, 2024.
- USDA. 510(k) premarket notification: K242256. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242256. Updated Nov. 4, 2024. Accessed Nov. 4, 2024.
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