Brea, California, USA, November 3, 2026
Beckman Coulter Diagnostics, a Danaher company and global leader in clinical diagnostics, has announced that it has received U.S. Food and Drug Administration (FDA) clearance for its Access MeMed BV® assay, an innovative blood-based diagnostic test designed to help healthcare professionals distinguish between bacterial and viral infections in adults and children. The newly cleared assay provides diagnostic results in as little as 15 minutes on the DxI 9000 immunoassay analyzer, representing an important advancement in rapid infectious disease testing and clinical decision support. Developed in collaboration with MeMed, a company specializing in host-response diagnostics, the test measures specific proteins produced by the body’s immune system in response to infection. Unlike conventional diagnostic approaches that primarily identify the presence of individual pathogens, the Access MeMed BV assay evaluates the body’s biological response to help determine whether an infection is more likely to be bacterial or viral. The technology is designed for use in emergency departments, urgent care facilities and hospital settings, providing clinicians with additional information when making treatment decisions. The FDA clearance expands access to rapid host-response testing and highlights the growing role of advanced diagnostic technologies in supporting appropriate antibiotic use and improving patient management.
FDA Clearance Advances Rapid Bacterial and Viral Testing
The Access MeMed BV assay uses a host-response diagnostic approach to differentiate bacterial from viral infections by measuring three important immune-response proteins: TRAIL (TNF-related apoptosis-inducing ligand), IP-10 (interferon gamma-induced protein 10) and CRP (C-reactive protein). These biomarkers reflect different immune responses associated with infections and are combined through an algorithm to generate a score indicating the likelihood of bacterial infection. The test is intended for adult and pediatric patients with suspected acute infections and symptoms lasting fewer than seven days. It is designed to support clinical assessment alongside other laboratory findings rather than replace a physician’s evaluation or established diagnostic methods. The assay can be used with serum or plasma samples and is intended for patients evaluated in emergency departments, urgent care settings or through samples collected at hospital admission. Importantly, the technology has been cleared for use in children as young as 90 days old, extending its potential application to pediatric populations where distinguishing bacterial and viral infections can be particularly challenging. By providing objective information about the body’s immune response, the assay may help clinicians make more informed decisions when evaluating patients with overlapping infection symptoms.
15-Minute Results Support Antibiotic Stewardship
One of the key advantages of the newly cleared assay is its integration with existing Beckman Coulter diagnostic instruments. The Access MeMed BV assay is available on the DxI 9000 and Access 2 immunoassay analyzers, which are already installed in hospital laboratories across the United States. On the DxI 9000 Analyzer, results can be generated in as little as 15 minutes, helping healthcare professionals access relevant diagnostic information without introducing additional laboratory instrumentation or significantly changing established workflows. Rapid differentiation between bacterial and viral infections is important because both can produce similar symptoms, including fever, fatigue, cough and respiratory complications. Without timely diagnostic information, clinicians may prescribe antibiotics when they are not necessary. Antibiotics are effective against bacterial infections but do not treat viral illnesses, and inappropriate antibiotic use contributes to the growing problem of antimicrobial resistance. The new assay is designed to support antibiotic stewardship by providing additional evidence to guide treatment decisions. Published health-economic modelling cited in the announcement estimated approximately 1,129 fewer antibiotic treatment days per 1,000 patients with community-acquired pneumonia when MeMed BV was incorporated into the diagnostic standard of care. These findings highlight the potential value of host-response testing in improving antibiotic utilization, although clinical decisions must continue to consider each patient’s overall condition and other diagnostic findings.
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Beckman Coulter and MeMed Expand Diagnostic Innovation
The FDA clearance represents an important achievement for Beckman Coulter Diagnostics and its collaboration with MeMed, combining established laboratory automation capabilities with innovative immune-response technology. According to the companies, clinical studies and real-world evidence have demonstrated the potential of MeMed BV testing to support or influence treatment decisions in patients with suspected infections. Research has also explored its role in reducing unnecessary antibiotic prescriptions, additional diagnostic testing and avoidable hospital admissions. In one real-world evaluation at Tampa General Hospital, integrating MeMed BV into an emergency department sepsis alert workflow was associated with an estimated $1,790 reduction in cost per patient, primarily through potentially avoidable admissions among patients considered unlikely to have bacterial sepsis. These findings provide further support for investigating the clinical and economic value of rapid host-response diagnostics. The Access MeMed BV assay previously received CE marking in April 2026, and its U.S. FDA clearance now expands its regulatory availability into another major healthcare market. Through this collaboration, Beckman Coulter and MeMed aim to make rapid diagnostic insights more accessible to healthcare providers while supporting responsible antibiotic use. Overall, the regulatory milestone demonstrates continued innovation in laboratory diagnostics and reinforces the importance of timely infection assessment, particularly among vulnerable patients, including young children and older adults.
Source: Beckman Coulter Diagnostics press release
