Beckman Coulter earns CE mark approval for new rapid infection test
A new high-throughput assay delivers bacterial versus viral infection results in just 20 minutes, supporting faster clinical decisions and improved antibiotic stewardship across European healthcare systems.
Beckman Coulter Diagnostics (CA, USA) has received CE 2797 marking under IVDR for its Access MeMed BV assay, a new diagnostic test designed to distinguish between bacterial and viral infections in approximately 20 minutes. Developed in partnership with MeMed (Haifa, Israel), the assay is compatible with existing DxI 9000 and Access 2 immunoassay analyzers, enabling rapid deployment across laboratories. The innovation aims to improve clinical decision-making while addressing the urgent need for faster, more accurate infection diagnosis.
Differentiating bacterial from viral infections remains a persistent challenge, often leading to unnecessary antibiotic use and avoidable healthcare costs. Traditional diagnostic methods can take hours or days, delaying appropriate treatment and contributing to antimicrobial resistance.
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The Access MeMed BV assay uses host-response testing to provide actionable insights within minutes, supporting clinicians when time-critical decisions are required. Supporting studies involving nearly 6,000 patients demonstrated that the test changed or confirmed clinical treatment decisions in up to 87% of cases, with a negative predictive value of up to 99% for ruling out bacterial infections.
“By delivering rapid, highly reliable bacterial and viral differentiation on routine immunoassay systems, we’re empowering care teams with the timely insights they need to guide appropriate treatment decisions, while optimizing laboratory efficiency using existing workflows,” explained Melissa Naiman, Senior Director of Medical Affairs at Beckman Coulter Diagnostics.
Health-economic modelling also suggests significant cost savings. For every 1,000 patients assessed for community-acquired pneumonia, the assay could save over £134,000 in adult care and £105,750 in pediatrics by reducing hospitalizations, diagnostic procedures and unnecessary antibiotic prescriptions.
By integrating into existing laboratory workflows, the assay offers a scalable solution to improve diagnostic speed, accuracy and efficiency without requiring new infrastructure. As demand for rapid diagnostics grows, such host-response technologies may become central to routine infection management worldwide.
