Beckman Coulter Diagnostics Earns CE Mark for New Assay Delivering Bacterial vs. Viral Infection Results in Approximately 20 Minutes

Modeling Shows Adoption of New Access MeMed BV Assay Could Cut up to €80M in Avoidable Costs across European Health Systems through Fewer Unnecessary Admissions and Testing 

BREA, Calif., April 13, 2026 /PRNewswire/ -- Beckman Coulter Diagnostics, a Danaher company and global leader in clinical diagnostics, today announced it has received CE 2797 mark under IVDR for the Access MeMed BV assay, enabling broad availability of a high-throughput host‑response test that helps clinicians differentiate between bacterial and viral infections in approximately 20 minutes.

Validated for use across Beckman Coulter's installed base of DxI 9000 and Access 2 immunoassay analyzers, the Access MeMed BV assay enables fast, reliable infection differentiation while leveraging laboratories' existing infrastructure and workflows. Beckman Coulter partnered with MeMed, a leader in advanced host‑response technologies, to bring the proven MeMed BV^® test into core laboratory settings. The MeMed BV test has been shown to enhance clinical decision‑making, support clinicians in curbing unnecessary antibiotic use, and advance antimicrobial‑stewardship initiatives—results reinforced by strong clinical studies and real‑world performance data.^1-7

Published MeMed economic data, together with incidence estimates for lower respiratory tract infections (LRTI) and community‑acquired pneumonia (CAP), indicate that European healthcare systems shoulder significant avoidable costs each year.^8-10 With Access MeMed BV now available on Beckman Coulter's extensive installed base across Europe, healthcare systems have a scalable, practical path to help potentially reduce up to €80 million in avoidable costs through reductions in unnecessary admissions and diagnostic testing.

"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 at Beckman Coulter Diagnostics."

"This collaboration with Beckman Coulter significantly accelerates our mission to make host-response testing available at scale," said Eran Eden, CEO & Co-founder, MeMed. "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."

Fast Insights Guides Confident Clinical Decisions

Bacterial and viral infections frequently present with similar symptoms, making early differentiation challenging and sometimes leading to inappropriate patient management or unnecessary antibiotic use. Early distinction is critical because clinicians often must prescribe treatment before traditional diagnostic methods—which can take hours or days—to deliver definitive results. The Access MeMed BV assay provides actionable bacterial vs. viral insights in approximately 20 minutes, using Beckman Coulter immunoassay analyzers to generate rapid results at scale.

Recent real-world studies across nearly 6,000 adult and pediatric patients found that clinicians face uncertainty about antibiotic prescribing in approximately 16–29% of cases.^3-5 Following receipt of MeMed BV results, physicians reported that the test supported or changed clinical decision-making in approximately 82–87% of cases. In prior blinded multicenter validation studies, MeMed BV demonstrated up to 99% negative predictive value (NPV) as an aid in excluding bacterial infection.^11-13

Reducing Costs, Hospitalizations, and Unnecessary Antibiotic Use at Scale

Challenges in accurately identifying bacterial versus viral infections early can drive downstream healthcare costs, unnecessary admissions, and repeat testing. Independent health‑economic modeling highlights the potential value of incorporating MeMed BV into routine care.¹⁰

For every 1,000 patients evaluated for suspected community-acquired pneumonia (CAP), incorporating MeMed BV into clinical decision-making‑ generated substantial efficiencies. In adults, the model showed £134,018 in total cost savings, while pediatric care realized £105,750 in avoided costs. These financial gains were driven by more targeted antibiotic use, reduced hospitalizations, and fewer diagnostic procedures—resulting in streamlined care pathways and lower resource consumption.¹⁰

About Access MeMed BV Assay

The Access MeMed BV Assay is a diagnostic test indicated for use in patients presenting to a medical center and inpatients with suspected acute bacterial or viral infection. The test integrates measurements of three key host-immune proteins (TRAIL, IP-10, and CRP) into a score indicating the likelihood of bacterial or viral infections.

About Beckman Coulter. Inc.

A global leader in advanced diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what's now to what's next. We do this by accelerating care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimize lab performance services. Beckman Coulter is part of the Danaher Corporation (NYSE:DHR) family of global science and technology companies. Headquartered in Brea, Calif., it has more than 11,000 global team members.

Follow and connect with Beckman Coulter via LinkedIn, Twitter, and Facebook.

ABOUT DANAHER

Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Through our connected ecosystem of industry-leading businesses, we work side by side with customers to solve their most complex scientific and clinical challenges—helping move innovations from discovery to delivery faster for patients who depend on them.

Powered by the Danaher Business System, our advanced science and technology and proven ability to innovate help enable faster, more accurate diagnoses and reduce the time, cost, and risk required to discover, develop, and deliver life-changing therapies. Through continuous improvement and operational excellence, our approximately 60,000 associates worldwide are focused on delivering lasting impact and improving quality of life around the world, while building a healthier, more sustainable tomorrow.

© 2026 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. MeMed BV is a registered trademark for MeMed. 2026-15295

1 Singer et al. 2025. Effect of host-protein test (TRAIL/IP-10/CRP) on antibiotic prescription and emergency department or urgent care center return visits: the JUNO pilot randomized controlled trial. Academic Emergency Medicine Journal.

2 LoVerde et al. 2025. Real-world study assessing sensitivity and clinical utility of a host-protein test in adult emergency departments patients with blood culture ordered. JACEP Open.

3 Kalmovich B. et al. 2023. Impact on patient management of a novel host response test for distinguishing bacterial from viral infections: real world evidence from the urgent care setting. Biomedicines.

4 Kalmovich B. et al. 2025. Implementation of a rapid host-protein diagnostic test for distinguishing bacterial and viral infections in adults presenting to urgent care centers: a pragmatic cohort study. BMC Medicine.

5 Kalmovich B. et al. 2025. Use of a host-protein test for pediatric acute infections at urgent care centers. Pediatrics.

6 Diamantopoulou P. et al. 2026. Real-world utility of the host-response MeMed BV test in a pediatric emergency department: A non-randomized study with optimized antimicrobial and diagnostic stewardship. Children.

7 van Houten C.B. et al. 2016. A host-protein based assay to differentiate between bacterial and viral infections in preschool children (OPPORTUNITY): a double-blind, multicentre, validation study. Lancet Infectious Diseases.

8 Bender R. et al. 2024. Global, Regional, and national incidence and mortality burden of non-COVID-19 lower respiratory infections and aetiologies, 1990-2021: a systematic analysis from the global burden of disease study 2021.

9 Reyes L.F. et al. 2025. Community-acquired pneumonia. The Lancet.

10 Gregg E. et al. 2025. Host-response testing with MeMed BV in community-acquired pneumonia: an economic evaluation from the UK NHS perspective. JAC-Antimicrobial Resistance.

11 Bachur R.G. et al. 2024. A rapid host-protein test for differentiating bacterial from viral infection: Apollo diagnostic accuracy study. JACEP Open.

12 Allen C. et al. 2025. Development of a reference standard to assign bacterial versus viral infection etiology using an all-inclusive methodology for comparison of novel diagnostic tool performance. Clinical Infectious Diseases.

13 Papan C. et al. 2022. A host signature based on TRAIL, IP-10, and CRP for reducing antibiotic overuse in children by differentiating bacterial from viral infections: a prospective, multicentre cohort study.

SOURCE Beckman Coulter Diagnostics