Beckman Coulter Diagnostics receives CE mark for Access MeMed BV assay, enabling rapid bacterial vs viral infection differentiation
Beckman Coulter Diagnostics has announced receipt of the CE 2797 mark under the In Vitro Diagnostic Regulation (IVDR) for its Access MeMed BV assay – a host-response test capable of differentiating bacterial from viral infections in approximately 20 minutes on routine immunoassay analysers.
The assay was developed through a partnership with MeMed, an Israeli diagnostics company specialising in host-response technology. It has been validated for use on Beckman Coulter’s installed base of DxI 9000 and Access 2 immunoassay analysers, enabling high-throughput deployment within existing laboratory workflows without the need for additional capital equipment.
Host-response mechanism and biomarker profile
The Access MeMed BV assay measures three host-immune proteins – TRAIL, IP-10, and CRP – integrating the values into a composite score that indicates the likeli-hood of bacterial versus viral aetiology. This host-response approach addresses a longstanding clinical challenge: bacterial and viral infections frequently present with overlapping signs and symptoms, making early differentiation difficult and sometimes resulting in empirical antibiotic therapy before confirmatory results are available from conventional diagnostic methods.
Blinded multicentre validation studies have demonstrated that MeMed BV achieves up to 99% negative predictive value (NPV) as an aid in excluding bacterial infection. Real-world studies involving nearly 6,000 adult and paediatric patients found that clinicians faced prescribing uncertainty in approximately 16–29% of cases; following receipt of MeMed BV results, physicians reported that the test supported or changed clinical decision-making in approximately 82–87% of cases.
Clinical and economic implications
Independent health-economic modelling, published from a UK NHS perspective in JAC-Antimicrobial Resistance, assessed the value of incorporating MeMed BV into the management of community-acquired pneumonia (CAP). For every 1,000 adult patients evaluated for suspected CAP, the model projected total cost savings of £134,018, with paediatric care realising £105,750 in avoided costs. These figures were driven by more targeted antibiotic prescribing, reduced hospital admissions, and fewer ancillary diagnostic procedures.
Extrapolating published MeMed economic data with incidence estimates for lower respiratory tract infections and CAP across European health systems, the companies project that broad adoption of the assay could reduce avoidable costs by up to €80 million 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 optimising laboratory efficiency using existing workflows,” said Melissa Naiman, Medical & Scientific Affairs at Beckman Coulter Diagnostics.
Antimicrobial stewardship integration
Antimicrobial stewardship programmes stand to benefit directly from the assay’s deployment at scale. Evidence from real-world studies has shown MeMed BV supports clinicians in reducing unnecessary antibiotic use – a key concern given rising rates of antimicrobial resistance globally. The assay’s availability on high-throughput core laboratory platforms, rather than point-of-care devices alone, enables integration into broader institutional stewardship frameworks.
Eran Eden, CEO and co-founder of MeMed, said: “This collaboration with Beckman Coulter significantly accelerates our mission to make host-response testing available at scale. Making the assay available on high-throughput laboratory analysers allows healthcare systems to unlock those benefits for far more patients.”
Regulatory status and availability
The Access MeMed BV assay carries the CE 2797 mark under IVDR and is indicated for use in patients presenting to a medical centre with suspected acute bacterial or viral infection, as well as inpatients under investigation. The assay is now available across Beckman Coulter’s European installed base.
Beckman Coulter Diagnostics is a Danaher company (NYSE: DHR) headquartered in Brea, California, with more than 11,000 employees globally.
For more information, visit: www.beckmancoulter.com
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