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FDA Clears Qiagen QiaStat-Dx Meningitis/Encephalitis Panel

NEW YORK – Qiagen announced Monday that the US Food and Drug Administration has cleared the company's QiaStat-Dx panel for the detection of pathogens that can cause meningitis and encephalitis.

The QiaStat-Dx Meningitis/Encephalitis Panel is the fourth syndromic panel to obtain FDA clearance for the firm's multiplex qPCR QiaStat-Dx system. A version of the test was CE marked in Europe in 2022.

Last week, the firm said that its QiaStat-Dx Respiratory Panel Mini syndromic multiplex qPCR test was FDA cleared.

The multiplex meningitis and encephalitis qPCR test was developed specifically for US markets, Qiagen said in a statement, and detects infectious M/E-causing pathogens in approximately one hour while also providing users with cycle thresholds and amplification curve results for the test.

"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," said Fernando Beils, senior VP and head of molecular diagnostics at Qiagen.

The M/E panel detects nine bacterial targets, five viral targets, and one target that detects two species of fungi known to cause brain infections. Specifically, it detects Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, encapsulated Neisseria meningitidis, Streptococcus agalactiae, Streptococcus pneumoniae, Mycoplasma pneumoniae, Streptococcus pyogenes, herpes simplex virus 1, HSV 2, human herpes virus 6, enterovirus, human parechovirus, varicella zoster virus, and Cryptococcus neoformans/gattii, according to instructions for use on Qiagen's website.