Seegene said on the 21st it has launched a new product for detecting multidrug-resistant organisms (MDRO), the "Allplex™ MDRO Assay," in the European market.
The product is a molecular diagnostic solution developed to reflect the requirements of the European in vitro diagnostic medical devices regulation (IVDR) and is used to detect multidrug-resistant organisms and resistance genes associated with healthcare-associated infections (HAI). Multidrug-resistant organisms are pathogenic microorganisms resistant to multiple types of antibiotics.
The "Allplex MDRO Assay" is based on real-time multiplex polymerase chain reaction (PCR) technology and is designed to simultaneously detect major multidrug-resistant pathogens and resistance genes with a single test.
It also features the ability to support infection prevention and control before culture test results are available through PCR-based first-line screening. The company said it can provide information needed for monitoring in-hospital infection risk, early response, and building infection control systems more quickly.
The launch is part of a strategy to strengthen the infection control diagnostics portfolio in line with growing demand to address antimicrobial resistance (AMR).
As antibiotic resistance worsens worldwide, the burden of healthcare-associated infections is also growing. According to the U.S. Centers for Disease Control and Prevention (CDC), antibiotic-resistant infections in U.S. hospitals increased by about 20% during the COVID-19 pandemic and have since remained above pre-pandemic levels.
Seegene said the new product, when used together with the existing "Allplex Entero-DR Assay" for drug resistance testing, can extend beyond intestinal resistance organism testing to cover major pathogens with high in-hospital infection risk. The company expects this to more systematically expand the scope of infection control responses at medical institutions.
Seegene plans to strengthen its capabilities to respond to healthcare-associated infections and to refine related strategies in line with growing demand for infection surveillance and management. In addition, it is developing a new product for detecting methicillin-resistant Staphylococcus aureus (MRSA), the "Allplex MRSA Assay," with a goal of launching it next year. The product will first be supplied to the European market, and global supply will be expanded step by step according to each market's regulatory environment and medical needs.
Shin Dae-ho, executive vice president and head of global sales and marketing at Seegene, said, "This product launch is an important step that enables broader diagnostic responses in hospital infection control settings," and added, "We will continue to develop diagnostic solutions that can be effectively used in real-world clinical settings."