Seegene has launched a new molecular diagnostic assay for multidrug-resistant organisms (MDRO) in Europe, expanding its infectious disease testing portfolio as hospitals face growing pressure to strengthen infection prevention and antimicrobial resistance monitoring.
Seegene’s Allplex MDRO Assay is designed to help hospitals detect multidrug-resistant organisms and resistance genes more quickly as demand grows for stronger infection prevention and antimicrobial resistance monitoring. (Credit: Seegene)
The Korean molecular diagnostics company said Thursday that it introduced Allplex MDRO Assay, a product designed to detect MDROs and related resistance genes associated with healthcare-associated infections.
The assay was developed to reflect requirements under the European Union’s In Vitro Diagnostic Medical Devices Regulation, or IVDR, and will be supplied first in the European market.
Allplex MDRO Assay is based on real-time multiplex PCR technology and can simultaneously detect major multidrug-resistant pathogens and resistance genes in a single test. Seegene said the product is designed to support faster infection prevention and control by enabling PCR-based primary screening before culture test results become available.
The company said the assay can help medical institutions monitor hospital infection risks, respond earlier to potential outbreaks and obtain information needed for infection control measures more quickly.
The launch comes as antimicrobial resistance, or AMR, has become a growing global health concern, increasing the burden of healthcare-associated infections and driving demand for faster and more comprehensive diagnostic tools.
According to data from the U.S. Centers for Disease Control and Prevention cited by the company, antibiotic-resistant infections in U.S. hospitals rose about 20 percent during the Covid-19 pandemic and have remained above pre-pandemic levels. The increased use of antibiotics and the spread of hospital-acquired infections after Covid-19 have further highlighted the need to upgrade infection control systems.
Seegene said the new product is part of its strategy to broaden its diagnostic portfolio in response to the changing infectious disease environment and rising demand for antimicrobial resistance testing.
When used together with the company’s existing Allplex Entero-DR Assay, the new assay is expected to complement testing focused on intestinal resistant bacteria and support a broader testing system covering major pathogens linked to high hospital infection risks.
The combination could allow healthcare institutions to build a more systematic response to infections involving antibiotic-resistant bacteria.
“The launch of this product is not simply the addition of a new assay, but an important step that enables broader diagnostic responses in hospital infection control settings,” said Shin Dae-ho, chief global sales and marketing officer at Seegene. “We will continue developing diagnostic solutions that can be effectively used in real clinical environments.”
The company is also developing Allplex MRSA Assay, a new product for detecting methicillin-resistant Staphylococcus aureus, with a target launch next year.
Lee Han-soo
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