QIAGEN receives ARTG inclusion for QIAstat-Dx Meningitis Panel to support rapid diagnosis in Australia

QIAstat-Dx Meningitis/Encephalitis Panel enables detection of 16 pathogens from a single CSF sample, aligned with World Health Organization (WHO) recommendation

QIAGEN announced that its QIAstat-Dx Meningitis/Encephalitis (ME) Panel has been included in the Australian Register of Therapeutic Goods (ARTG). The inclusion marks rapid molecular testing for the detection of pathogens associated with central nervous system (CNS) infections, supporting timely clinical decision-making in acute care settings.

The QIAstat-Dx ME Panel enables fast detection of 16 common bacterial, viral and fungal pathogens using multiplex PCR from a single cerebrospinal fluid (CSF) sample. These include cytomegalovirus (CMV) and Streptococcus pyogenes, providing actionable diagnostic information for meningitis and encephalitis cases.

Meningitis and encephalitis require timely clinical management and rapid identification of the causative pathogen is important for patient care. Diagnostic delays may increase clinical uncertainty and impact treatment decisions.

The World Health Organisation (WHO) has recently issued a strong recommendation for PCR-based testing to ensure the fastest possible detection of pathogens in patients with suspected meningitis. The IVDR-compliant QIAstat-Dx ME Panel supports alignment with current guidelines and enables multiplex detection of a range of bacterial, viral and fungal pathogens.

“Ensuring that the right test reaches the right patient at the right time is fundamental to strengthening public health preparedness and improving patient outcomes,” said Piers Murray, Head of Sales, Australia and New Zealand at QIAGEN. “Broader access to syndromic testing supports earlier and accurate identification of serious infections, enabling confident clinical decisions. QIAGEN remains committed to further expanding its syndromic testing portfolio to make improvements in life possible.”

With this latest inclusion, QIAGEN continues to strengthen its QIAstat-Dx syndromic testing portfolio in Australia, complementing the existing QIAstat-Dx Respiratory SARS-CoV-2 Panel and QIAstat-Dx Gastrointestinal Panel.

The QIAstat-Dx system is designed for use in laboratories and employs cost-efficient, single-use cartridges with all reagents on board and built-in sample processing. The QIAstat-Dx uniquely provides cycle threshold (Ct) values and amplification curves, offering immediately viewable information for detected pathogens and supporting healthcare professionals with additional clinical insight beyond end-point PCR and other techniques.

QIAstat-Dx integrates sample preparation, molecular testing and data analysis into a single workflow. The systems are available in more than 100 countries, with more than 5,200 instruments placed worldwide as of the end of 2025.