Beckman Coulter Diagnostics, a Danaher company and a global leader in clinical diagnostics, today announced that it has received the CE 2797 mark under IVDR for the Access MeMed BV assay. This enables widespread use of high-throughput host response tests that allow clinicians to differentiate between bacterial and viral infections in about 20 minutes.
Image credit: Beckman Coulter Diagnostics
Validated for use across the installed base of Beckman Coulter’s DxI 9000 and Access 2 immunoassay analyzers, the Access MeMed BV assay enables rapid and reliable identification of infections while leveraging a laboratory’s existing infrastructure and workflow. Beckman Coulter has partnered with MeMed, a leader in advanced host response technology, to bring the proven MeMed BV® test to core laboratory settings. The MeMed BV test has been shown to enhance clinical decision-making, support clinicians in reducing unnecessary antibiotic use, and advance antimicrobial stewardship efforts, with results supported by strong clinical research and real-world performance data.
Economic data published by MeMed, together with lower respiratory tract infections (LRTI) and community-acquired pneumonia (CAP) incidence estimates, show that European health systems incur significant avoidable costs each year. With Access MeMed BV now available across Beckman Coulter’s extensive installed base across Europe, health systems now have a scalable and practical path to potentially saving up to €80 million in avoidable costs through the reduction of unnecessary hospitalizations and diagnostic tests.
Achieving rapid and reliable differentiation of bacteria and viruses in routine immunoassay systems allows you to use existing workflows to optimize laboratory efficiency while providing healthcare teams with the timely insights they need to guide appropriate treatment decisions. ”
Melissa Naiman, Medical Sciences, Beckman Coulter Diagnostics
“This collaboration with Beckman Coulter significantly accelerates our mission to make host response testing available at scale.” Eran Eden, CEO and co-founder of MeMed, said: “The MeMed BV test has repeatedly demonstrated its ability to improve clinical decision-making, help clinicians reduce unnecessary antibiotic use, and support antimicrobial stewardship. This is supported by strong clinical and real-world evidence. By making this test available on high-throughput clinical laboratory analyzers, health systems can unlock its benefits to a much larger number of patients.”
Rapid insights guide confident clinical decision making
Bacterial and viral infections often present with similar symptoms, making early differentiation difficult and sometimes leading to inappropriate patient management and unnecessary antibiotic use. Early differentiation is important because clinicians often have to prescribe treatment ahead of traditional diagnostic methods, which can take hours or days to produce final results. The Access MeMed BV assay uses the Beckman Coulter Immunoassay Analyzer to produce large-scale, rapid results, providing actionable bacteria-versus-virus insights in approximately 20 minutes.
A recent real-world study of approximately 6,000 adult and pediatric patients found that clinicians faced uncertainty about prescribing antibiotics in approximately 16-29% of cases. After receiving MeMed BV results, physicians reported that the test supported or changed clinical decision-making in approximately 82 to 87 percent of cases. In a previous blinded multicenter validation study, MeMed BV demonstrated up to 99% negative predictive value (NPV) in helping eliminate bacterial infections.
Massively reducing costs, hospitalizations, and unnecessary antibiotic use
The challenge of early and accurate identification of bacterial and viral infections can increase downstream healthcare costs, lead to unnecessary hospitalizations, and repeat testing. Independent health economic modeling highlights the potential value of incorporating MeMed BV into routine care.
Significant efficiencies were achieved by incorporating MeMed BV into clinical decision-making for every 1,000 patients assessed for suspected community-acquired pneumonia (CAP). The model showed a total cost savings of £134,018 for adults, while cost savings of £105,750 were achieved for pediatric care. These economic benefits result from more targeted antibiotic use, fewer hospitalizations, and fewer diagnostic procedures, resulting in streamlined treatment pathways and reduced resource consumption.
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