The high-throughput host-response assay provides results in approximately 20 minutes to help guide treatment decisions and antimicrobial stewardship.

Beckman Coulter Diagnostics received CE Mark under In Vitro Diagnostic Regulation (IVDR) for the Access MeMed BV assay, a high-throughput host-response test that helps clinicians differentiate between bacterial and viral infections in approximately 20 minutes, according to a company press release.

The assay is validated for use on the DxI 9000 and Access 2 immunoassay analyzers. Developed in partnership with MeMed, the test is designed to leverage existing laboratory infrastructure and workflows to provide fast, [reliable infection differentiation]. The assay aims to support clinicians in reducing unnecessary antibiotic use and advancing antimicrobial stewardshipp initiatives.

“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,” says Melissa Naiman, medical and scientific affairs at Beckman Coulter Diagnostics, in a release.

Clinical and Economic Impact

Bacterial and viral infections frequently present with similar symptoms, making early differentiation difficult. Because traditional diagnostic methods can take hours or days to deliver results, clinicians often prescribe treatment before a definitive diagnosis is available. The Access MeMed BV assay measures three host-immune proteins—TRAIL, IP-10, and C-reactive protein—to generate a score indicating the likelihood of a bacterial or viral infection.

Recent real-world studies involving nearly 6,000 adult and pediatric patients found that clinicians face uncertainty regarding antibiotic prescribing in 16% to 29% of cases. Following the receipt of MeMed BV results, physicians reported that the test supported or changed clinical decision-making in 82% to 87% of cases. In prior blinded multicenter validation studies, the test demonstrated a 99% negative predictive value for excluding bacterial infections.

Economic modeling indicates that adopting the assay across European health systems could reduce avoidable costs by up to €80 million through a reduction in unnecessary hospital admissions and diagnostic testing, according to the release.

“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,” says Eran Eden, CEO and co-founder, MeMed, in a release. “Making the assay available on high-throughput laboratory analyzers allows healthcare systems to unlock those benefits for far more patients.”

Efficiency in Respiratory Care

The diagnostic test is indicated for use in patients presenting to medical centers and inpatients with suspected acute infections. For every 1,000 patients evaluated for suspected community-acquired pneumonia (CAP), health-economic modeling showed substantial efficiencies.

In adult populations, the model generated £134,018 in total cost savings, while pediatric care realized £105,750 in avoided costs. These gains were driven by more targeted antibiotic use, fewer diagnostic procedures, and reduced hospitalizations for CAP and lower respiratory tract infections.

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