Beckman Coulter Secures CE Mark for 20-Minute Infection Assay with €80M Savings Potential
Beckman Coulter Diagnostics obtained CE 2797 mark under IVDR for its Access MeMed BV assay, enabling bacterial vs viral infection results on DxI 9000 and Access 2 analyzers in 20 minutes. Economic modeling suggests broad adoption across Europe could save up to €80 million by reducing unnecessary admissions and testing.
1. CE Mark Approval and Assay Features
Beckman Coulter Diagnostics obtained CE 2797 mark under IVDR for the Access MeMed BV assay, allowing high-throughput differentiation between bacterial and viral infections in 20 minutes on DxI 9000 and Access 2 immunoassay analyzers.
2. Clinical Performance and Decision Impact
Real-world studies across nearly 6,000 patients showed the assay supported or changed clinical decision-making in 82–87% of cases and exhibited up to 99% negative predictive value for excluding bacterial infection in multicenter validation.
3. Economic Benefits Across Europe
Health-economic modeling indicates that broad adoption could reduce unnecessary admissions and diagnostic procedures, cutting up to €80 million in avoidable costs and generating per-1,000-patient savings of £134,018 in adults and £105,750 in pediatric care.
4. Strategic Partnership and Deployment
The collaboration with MeMed leverages established laboratory workflows and existing Beckman Coulter infrastructure, positioning healthcare systems to scale antimicrobial stewardship and optimize diagnostics without additional equipment investments.