Seegene Launches Allplex™ MDRO Assay in Europe to Enhance AMR Testing Portfolio

Seegene Expands AMR Testing Capabilities with Allplex™ MDRO Assay

On June 1, 2026, Seegene, a leading global molecular diagnostics company, announced the launch of its innovative Allplex™ MDRO Assay in Europe. This new assay has received CE marking under the EU In-Vitro Diagnostic Regulation (IVDR), marking a significant milestone in the realm of antimicrobial resistance (AMR) detection.

The Allplex™ MDRO Assay is designed specifically to identify multidrug-resistant organisms (MDROs) that pose serious risks in healthcare environments. By enabling the detection of various pathogens associated with healthcare-associated infections (HAI), this product enhances the diagnostic spectrum beyond antimicrobial-resistant enteric bacteria, prioritizing faster and more efficient infection control measures.

Key Features of the Allplex™ MDRO Assay

This cutting-edge test allows for simultaneous identification of critical multidrug-resistant pathogens and associated resistance genes. It offers a comprehensive detection approach that helps healthcare providers implement frontline molecular screening based on PCR technology, well ahead of culture results. Such timely insights can significantly enhance infection prevention and control (IPC) strategies within hospitals, an urgent necessity given the rising global incidence of AMR.

The global healthcare landscape is facing an escalation in AMR infections, leading to increased burdens on healthcare systems and underscoring the importance of advanced diagnostic tools. Entities like the Centers for Disease Control and Prevention (CDC) are advocating for improved infection surveillance and control capacities to combat the growing threat of resistant infections.

Integration into Existing Diagnostic Frameworks

The Allplex™ MDRO Assay complements Seegene’s previous offering, the Allplex™ Entero-DR test, allowing for a holistic diagnostic approach covering both resistant enteric bacteria and additional high-risk MDRO targets. This strategic integration enhances the ability to manage infections caused by resistant organisms, thereby strengthening Seegene's overall AMR testing portfolio.

One of the notable advantages of the Allplex™ MDRO Assay is its capacity to report results within the same day, adapting to laboratory workflows and supporting swift clinical decision-making. The ability to provide rapid feedback not only aids in infection control strategies but also enhances operational efficiency in laboratory settings, which is critical during peak infection periods.

Expert Insight

Daniel Shin, Executive Vice President and Global Sales and Marketing Director of Seegene, emphasized, "This launch represents much more than just a new product introduction; it marks a crucial advancement in our diagnostic portfolio aimed at supporting increasingly extensive hospital infection control strategies. We remain committed to developing diagnostic solutions that can be effectively implemented in real clinical settings."

As Seegene continues to navigate the complexities of AMR, they are launching an Allplex™ MRSA Assay, targeting methicillin-resistant Staphylococcus aureus (MRSA), slated for release next year. This addition will further illustrate Seegene’s commitment to enhancing diagnostic capabilities in responding effectively to AMR challenges.

Future Prospects and Innovations

Seegene is already planning to reinforce its diagnostic capabilities focused on healthcare-associated infections by evolving its strategy in alignment with the rising demand for advanced surveillance and infection control systems. Regulatory availability of this assay may vary by country and is subject to local regulatory requirements.

With over 25 years of experience, Seegene has established itself as a pioneer in molecular diagnostics, particularly throughout the COVID-19 pandemic, providing over 340 million tests across more than 100 countries. The Allplex™ MDRO Assay reaffirms Seegene's commitment to evolving diagnostic solutions that can combat the pressing issue of antimicrobial resistance while actively expanding access to molecular diagnostics globally.

For more information about the Allplex™ MDRO Assay and its implications in infection control, contact Junyong Lee at [email protected] or call +82-10-2297-3806.