Seegene lanza el ensayo Allplex™ MDRO bajo el Reglamento IVDR
Seegene has launched its new antimicrobial resistance (AMR) testing product, Allplex™ MDRO Assay, in Europe, marking its entry into the market under the European In Vitro Diagnostic Regulation (IVDR). The assay is designed to support the detection of multidrug-resistant organisms (MDROs) associated with healthcare-associated infections (HAIs).
The Allplex™ MDRO Assay aims to identify key multidrug-resistant pathogens and their associated resistance genes in a single test, thereby enabling rapid and simultaneous detection across a broader range of multidrug-resistant microorganisms. It provides initial rapid detection prior to obtaining culture results, contributing to timely infection prevention and control responses in hospital settings. This launch aligns with Seegene's strategy to expand its antimicrobial resistance analysis capabilities in response to evolving infectious disease trends.
As antimicrobial resistance continues to rise globally, the burden of healthcare-associated infections increases, driving the demand for faster and more comprehensive diagnostic methods. Health agencies, including the U.S. Centers for Disease Control and Prevention (CDC), emphasize the need to strengthen surveillance and infection control in healthcare environments.
The Allplex™ MDRO Assay complements Seegene's Allplex™ Entero-DR assay, allowing for a combined analytical approach covering both antimicrobial-resistant enteric bacteria and other high-risk MDRO targets. This integrated approach supports broader infection control efforts against antimicrobial-resistant organisms while enhancing Seegene's overall AMR testing portfolio. The assay enables simultaneous detection of multiple resistance genes and can generate same-day reports, providing timely information to support infection control responses and complementing conventional culture-based workflows.
Seegene plans to further enhance its diagnostic capabilities for healthcare-associated infections and advance its strategy in line with the increasing demand for improved surveillance and infection control. The product's availability may vary by country and is subject to local regulatory requirements. Additionally, the company is developing the Allplex™ MRSA assay for the detection of methicillin-resistant Staphylococcus aureus (MRSA), which is slated for launch next year as part of its AMR testing portfolio expansion.