Beckman Coulter Gains CE Mark for Rapid Assay Distinguishing Bacterial vs Viral Infections

That uncertainty can delay optimal care and drive unnecessary antibiotic use, straining antimicrobial‑stewardship efforts. Faster, reliable differentiation at scale is a recurring need for emergency departments, urgent care, and inpatient services. A newly launched assay now delivers approximately 20‑minute bacterial‑versus‑viral results on routine immunoassay systems to support more timely, appropriate management.

Beckman Coulter Diagnostics has received CE 2797 mark under IVDR for the Access MeMed BV assay, a high‑throughput host‑response test that helps clinicians differentiate bacterial and viral infections in approximately 20 minutes. The assay is validated for use on the company’s DxI 9000 and Access 2 immunoassay analyzers, allowing laboratories to leverage existing infrastructure and workflows. Developed in partnership with MeMed, the test brings the MeMed BV methodology into core laboratory settings across Europe.

Access MeMed BV is indicated for patients presenting to a medical center and for inpatients with suspected acute bacterial or viral infection. The test integrates measurements of three host‑immune proteins—TRAIL, IP‑10, and CRP—into a score indicating the likelihood of bacterial versus viral etiology. By running on installed Beckman Coulter immunoassay platforms, the method enables rapid turnaround without additional instrumentation or workflow disruption as described in the source.

Recent real‑world studies encompassing nearly 6,000 adult and pediatric patients reported antibiotic‑prescribing uncertainty in approximately 16–29% of cases. Following receipt of MeMed BV results, physicians indicated the test supported or changed clinical decision‑making in approximately 82–87% of cases. In prior blinded multicenter validation work, the assay demonstrated up to 99% negative predictive value as an aid in excluding bacterial infection.

Independent economic modeling and published data suggest substantial health‑system efficiencies when incorporating the assay into routine care. Across European health systems, adoption could help reduce up to €80 million in avoidable costs through fewer unnecessary admissions and diagnostic tests. For every 1,000 patients evaluated for suspected community‑acquired pneumonia, modeled analyses estimated total cost savings of £134,018 in adults and £105,750 in pediatric care, driven by more targeted antibiotic use, reduced hospitalizations, and fewer procedures.

"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," said Melissa Naiman, Medical & Scientific Affairs, Beckman Coulter Diagnostics.

"The MeMed BV test has repeatedly demonstrated its ability to improve clinical decision making, empower clinicians to reduce unnecessary antibiotic use, and support antimicrobial stewardship, backed by robust clinical and real-world evidence. Making the assay available on high-throughput laboratory analyzers allows healthcare systems to unlock those benefits for far more patients," said Eran Eden, CEO & Co-founder, MeMed.