The assay is CE marked under the European Union In Vitro Diagnostic Regulation and identifies resistance genes to help prevent hospital-acquired infections.
Seegene, a molecular diagnostics company, announced the European launch of its new antimicrobial resistance testing product, the Allplex MDRO Assay. The assay is CE marked under the European Union In Vitro Diagnostic Regulation and is designed to detect multidrug-resistant organisms associated with healthcare-associated infections, according to a company release.
The assay identifies multidrug-resistant pathogens and associated resistance genes in a single run. This allows for rapid detection across a wide range of multidrug-resistant organisms targets and supports first-line screening before culture-based results are available, which can help enable timely infection prevention and control responses in hospital settings.
“This launch represents more than just the addition of a new product. It marks an important step in expanding our diagnostic portfolio to support broader infection control efforts in hospital settings,” says Daniel Shin, executive vice president and chief global sales and marketing officer at Seegene, in a release.
As antimicrobial resistance continues to rise globally, the burden of healthcare-associated infections is increasing, leading to higher demand for fast diagnostic approaches. Public health agencies, including the US Centers for Disease Control and Prevention, have emphasized the importance of strengthened infection surveillance and control capabilities in healthcare settings.
Supporting Infection Control Efforts
The Allplex MDRO Assay complements the company’s existing Allplex Entero-DR Assay. According to Seegene, a combined testing approach covering antimicrobial-resistant enteric bacteria, high-risk multidrug-resistant organisms targets, and other resistance genes can support broader infection-control efforts.
The assay enables simultaneous detection of multiple resistance genes and can support same-day reporting depending on laboratory workflow. This provides information to support infection-control responses and can complement conventional culture-based workflows. It may also help support efficient laboratory workflows in appropriate clinical settings, the company says.
Seegene plans to further strengthen its diagnostic capabilities for healthcare-associated infections. The company is also developing the Allplex MRSA Assay for the detection of methicillin-resistant Staphylococcus aureus, which is targeted for launch next year as part of its strategy to expand its antimicrobial resistance testing portfolio.
Photo caption: Allplex MDRO Assay
Photo credit: Seegene
