New AMR Assay Supports Rapid Infection Control Screening in Hospitals

As antimicrobial resistance spreads worldwide, healthcare-associated infections are placing a growing burden on hospitals, increasing the need for faster and broader diagnostic solutions. To support infection control efforts, a newly launched test now offers IVDR-compliant first-line PCR screening for multidrug-resistant organisms in hospital settings.

Seegene has launched the Allplex MDRO Assay, a new antimicrobial resistance (AMR) testing product for the European market that is CE marked under the EU In Vitro Diagnostic Regulation (IVDR). The assay is designed to support detection of multidrug-resistant organisms (MDROs) associated with healthcare-associated infections and expands Seegene’s non-respiratory testing portfolio. By broadening the company’s previous focus on antimicrobial-resistant enteric bacteria to include additional high-risk MDRO targets encountered in hospitals, the assay is positioned as a rapid first-line screen for infection control workflows.

The assay identifies key multidrug-resistant pathogens together with associated resistance genes in a single run, enabling simultaneous detection across a broad panel of targets. By delivering polymerase chain reaction results before culture-based findings are available, the test is intended to help enable timely infection prevention and control actions. Depending on local workflow, laboratories can support same-day reporting, while maintaining conventional culture as a complementary method for organism confirmation and susceptibility testing.

The test also complements the Allplex Entero‑DR Assay, enabling a combined approach that covers antimicrobial-resistant enteric bacteria alongside additional hospital‑associated multidrug-resistant organisms. Seegene indicates this launch aligns with broader efforts to strengthen antimicrobial resistance testing capabilities in response to evolving infectious disease trends. The company is additionally developing the Allplex MRSA Assay targeting detection of methicillin‑resistant Staphylococcus aureus, planned for launch next year as part of its antimicrobial resistance testing expansion.

“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,” said Daniel Shin, Executive Vice President and Chief Global Sales and Marketing Officer at Seegene. “We will continue to develop diagnostic solutions that can be effectively implemented in real-world clinical environments.”