#South Korea #Seoul #Seegene #IVDR #Allplex MDRO

Seegene Introduces Allplex™ MDRO Assay in Europe

Seegene, a prominent international molecular diagnostics company, has recently announced the European launch of its new antimicrobial resistance (AMR) testing product, the Allplex™ MDRO Assay, compliant with the In Vitro Diagnostic Regulation (IVDR). This cutting-edge test aims to facilitate the detection of multidrug-resistant organisms (MDROs) associated with hospital-acquired infections (HAIs).

Overview of the Allplex™ MDRO Assay

The Allplex™ MDRO Assay is strategically designed to simultaneously identify key multidrug-resistant pathogens and their associated resistance genes. This capability enables quicker detection of a broader range of MDRO targets, allowing for timely actions against potential threats in hospitals. Particularly, the test supports rapid PCR screening that can be executed before culture results are available, thereby enhancing infection prevention efforts in healthcare settings.

As antimicrobial resistance escalates globally, the burden of hospital-acquired infections becomes increasingly severe, thus amplifying the need for faster and more comprehensive diagnostic approaches. Public health agencies, including the Centers for Disease Control and Prevention (CDC) in the United States, have consistently emphasized the importance of bolstering infection surveillance and control capabilities within healthcare facilities.

Complementing Existing Test Portfolios

The Allplex™ MDRO Assay complements Seegene’s existing Allplex™ ENTERO-DR Assay. Together, these tests provide a combined screening approach that encompasses a wide array of AMR-related targets, including high-risk MDROs. This integrated strategy aligns with ongoing efforts to improve infection control and prevention associated with antimicrobial resistance.

The Allplex™ MDRO Assay allows for the simultaneous detection of multiple resistance genes, potentially generating same-day reports aligning with laboratory workflow. The goal is to provide relevant information that aids in responding to infections while complementing conventional culture-based workflows. This innovation also aims to improve laboratory workflow efficiency in appropriate clinical settings.

Strategic Goals and Future Developments

Daniel Shin, Executive Vice President and Chief Marketing Officer of Seegene, stated, “This launch marks a significant advancement in our diagnostic portfolio aimed at supporting infection control efforts in hospitals. We are committed to developing diagnostic solutions that can be effectively implemented in real clinical environments.”

Seegene plans to enhance its diagnostic capabilities for hospital-acquired infections and advance its strategy based on the growing demand for improved surveillance and infection control. It is important to note that the product’s availability may vary by country, and it will be subject to local regulatory requirements.

Looking to the future, Seegene is also developing the Allplex™ test for the detection of Methicillin-resistant Staphylococcus aureus (MRSA), scheduled for launch next year as part of its broader AMR testing portfolio expansion strategy.

About Seegene

Seegene boasts over 25 years of expertise in research, development, and manufacturing of real-time PCR syndromic technologies. The company is globally recognized for its exclusive multiplex PCR technology, enabling the simultaneous detection of multiple pathogens in a single test. One notable feature of Seegene’s syndromic real-time PCR technology is its ability to detect up to 14 pathogens that cause similar signs and symptoms within a single tube, providing quantitative insights that bolster clinical decision-making.

Seegene’s technological capabilities were prominently displayed during the COVID-19 pandemic, where it supplied over 340 million COVID-19 tests to more than 100 countries worldwide. Building on its molecular diagnostic expertise, Seegene is transitioning towards developing an integrated diagnostic ecosystem and advancing new technologies, including STAgora™, a real-time diagnostic data analysis platform, and CURECA™, a fully automated PCR system designed to streamline molecular testing workflows. Through technology-sharing initiatives and global partnerships, Seegene aims to enhance access to molecular diagnostic technologies, promoting global preparedness against infectious diseases.