BREA, Calif., Nov. 3, 2026 /PRNewswire/ — Beckman Coulter Diagnostics, a Danaher company and a global leader in clinical diagnostics, today announced U.S. FDA clearance of the Access MeMed BV^® assay, a rapid host-response blood test that helps clinicians distinguish bacterial from viral infections in adult and pediatric patients. Available on the DxI 9000 and Access 2 immunoassay analyzers already installed in hospital laboratories nationwide, the new assay provides timely information aiding treatment decisions without requiring new instrumentation or changes to existing testing workflows. On the DxI 9000 Analyzer, results are available in as little as 15 minutes.

Developed in collaboration with MeMed, a leader in host-response diagnostics, the assay measures the body’s immune response to infection. Clinical studies and real-world evidence have demonstrated its potential to support clinicians to provide appropriate treatment decisions and antibiotic use. Additionally, published studies have shown the potential of the MeMed BV assay to reduce healthcare costs by decreasing unnecessary admissions and testing.^i,ii,iii

“By delivering bacterial and viral differentiation in as little as 15 minutes on the DxI 9000 Analyzer, we’re helping give clinicians greater confidence to make timely, appropriate treatment decisions,” said Melissa Naiman, Senior Director, Medical & Scientific Affairs, Acute Care at Beckman Coulter Diagnostics. “That added confidence can be particularly valuable when deciding whether antibiotics are appropriate, helping support responsible antibiotic use while ensuring patients, including children as young as 90 days old, who need antibiotics receive the care they need.”

Fast Insights Guide 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 must prescribe treatment before traditional diagnostic methods, which can take hours or days, deliver definitive results.

“In emergency medicine, clinicians frequently make treatment decisions before having complete diagnostic clarity,” said Dr. Michael B. Holbrook, MD, MBA, FACEP, Director of Emergency Informatics, Miami Valley Emergency Specialists and Physician Informaticist, Premier Health Partners. “Having timely, objective host-response information alongside our overall clinical assessment provides valuable data when evaluating whether an infection is likely bacterial or viral. Differentiating between the two not only supports appropriate antibiotic stewardship, but it also helps us communicate more clearly with patients about their diagnosis—giving them a better understanding of their illness and reassurance regarding why antibiotics may or may not be needed as part of their care plan.” 

Following receipt of MeMed BV results, physicians have reported that the test supports or changes clinical decision-making in a significant majority of cases. Validation studies have also demonstrated strong performance as an aid in excluding bacterial infection.^iv

Evaluating suspected infection in young children can be especially challenging because symptoms are often non-specific and patients may be unable to communicate their symptoms or medical history. Cleared for children as young as 90 days old, the Access MeMed BV assay provides objective host-response information for this diagnostically complex patient population.

By integrating seamlessly into existing laboratory workflows, the Access MeMed BV assay provides a scalable approach to delivering timely diagnostic insights, helping clinicians make more informed decisions while supporting broader public health efforts to combat antibiotic resistance.

Potential to Reduce Unnecessary Antibiotic Use and Healthcare Costs

Growing evidence points to the potential for MeMed BV to help clinicians reduce unnecessary antibiotic use and healthcare resource utilization.^v,vi Published health-economic modeling in patients with community-acquired pneumonia estimated approximately 1,129 fewer antibiotic days per 1,000 patients when MeMed BV was incorporated into the diagnostic standard of care. Separately, real-world data from Tampa General Hospital where MeMed BV was added to the ED sepsis alert order presented at the Society for Academic Emergency Medicine Annual Meeting reported an estimated $1,790 reduction in cost per patient primarily due to avoidable admissions among patients with unlikely bacterial sepsis.^vii

About Access MeMed BV Assay

The Access MeMed BV assay is an automated host-response test that measures three immune-response proteins, TRAIL, IP-10 and CRP, in serum or plasma from adult and pediatric patients with suspected acute infection and symptoms lasting fewer than seven days. The assay generates a score indicating the likelihood of bacterial infection and is intended for use in conjunction with clinical assessment and other laboratory findings for patients evaluated in emergency departments or urgent care settings, or from samples collected at hospital admission.

“This milestone significantly expands access to host-response diagnostics in one of the world’s largest healthcare markets,” said Eran Eden, CEO and Co-founder of MeMed. “In settings where early identification of bacterial infections—particularly those that may progress to sepsis—is critical, MeMed BV delivers important insights within minutes to empower clinicians to take timely action. Together with our partners at Beckman Coulter Diagnostics, we are enabling broader adoption of MeMed BV and helping healthcare systems deliver faster, more informed care while advancing antimicrobial stewardship.”

The Access MeMed BV assay was granted CE mark in April 2026.

About Beckman Coulter Diagnostics

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 optimized lab performance services. Beckman Coulter is part of the Danaher Corporation family of global science and technology companies. Headquartered in Brea, Calif., it has more than 10,000 global team members.

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About Danaher

Danaher is a leading global life sciences and diagnostics innovator, committed to advancing 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 many of their most complex scientific and clinical challenges—accelerating the moment scientific discovery becomes human impact. 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. That’s Innovation at the speed of life. Explore more at www.danaher.com.

© 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. The Danaher trademark is a proprietary mark of Danaher Corporation. MeMed BV is a registered trademark of MeMed.

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ⁱ Schneider & Cooper, Journal of Medical Economics (2022)
ⁱⁱ Wilson et al., SAEM 2026
ⁱⁱⁱ Singer et al. ACEP 2025
^iv 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.
Kalmovich B. et al. 2025. Use of a host-protein test for pediatric acute infections at urgent care centers. Pediatrics.
Bachur R.G. et al. 2024. A rapid host-protein test for differentiating bacterial from viral infection: Apollo diagnostic accuracy study. JACEP Open.
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.
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. Halabi et al. CMI (2023), Klein et al. Pediatrics (2023)
^v Antkowiak PS, Peacock WF, Singer AJ, Rothman RE, Bien-Willner GA. Antibiotic prescribing that aligns with a host-protein test at US acute care settings is associated with fewer subsequent hospitalisations. BMJ Open Qual. 2026;15(4):e004217. doi:10.1136/bmjoq-2026-004217.
^vi Singer AJ, Hollander JE, Kean ER, et al. 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. Acad Emerg Med. 2025;00:1-10. doi:10.1111/acem.70031
^vii O’Driscoll M, Silbert S, Tokaria T, Young S, Chamani A, Wind D, Munoz K, Wilson JW. Integrating a host-protein bacterial/viral test into the emergency department sepsis alert order set is associated with changes in sepsis category distribution and patient management: a pre/post-implementation study. In publication. Wilson J, Young S, Wind D, Chamani A. SAEM 2026. Silbert S. ADLM 2026. Disclosure: MeMed funded research assistants and provided tests.

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