The Beckman Coulter assay delivers results in as little as 15 minutes on existing immunoassay analyzers, potentially helping clinicians make faster treatment decisions.
Beckman Coulter Diagnostics announced US Food and Drug Administration clearance of the Access MeMed BV assay, a host-response blood test that helps clinicians distinguish bacterial from viral infections in adult and pediatric patients.
The assay runs on the DxI 9000 and Access 2 immunoassay analyzers already installed in hospital laboratories nationwide, so it requires no new instrumentation or changes to existing testing workflows, according to the company. On the DxI 9000, results are available in as little as 15 minutes.
Beckman Coulter developed the assay with MeMed, a host-response diagnostics company. The assay was granted CE mark in April 2026.
“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,” says Melissa Naiman, senior director of medical and scientific affairs, acute care, at Beckman Coulter Diagnostics, in a release.
How the Assay Works
The Access MeMed BV assay is an automated test that measures three immune-response proteins, TRAIL, IP-10, and CRP, in serum or plasma. It is intended for patients with suspected acute infection and symptoms lasting fewer than seven days. The assay generates a score indicating the likelihood of bacterial infection.
It is meant for use alongside clinical assessment and other laboratory findings in patients evaluated in emergency departments or urgent care settings, or from samples collected at hospital admission.
Bacterial and viral infections often present with similar symptoms, which can make early differentiation difficult and sometimes leads to inappropriate patient management or unnecessary antibiotic use. Clinicians typically must prescribe treatment before traditional diagnostic methods, which can take hours or days, return definitive results.
“In emergency medicine, clinicians frequently make treatment decisions before having complete diagnostic clarity,” says Michael B. Holbrook, MD, MBA, FACEP, director of emergency informatics at Miami Valley Emergency Specialists and physician informaticist at Premier Health Partners, in a release. “Having timely, objective host-response information alongside our overall clinical assessment provides valuable data when evaluating whether an infection is likely bacterial or viral.”
Holbrook adds that differentiating between the two supports antibiotic stewardship and helps clinicians explain a diagnosis to patients and clarify why antibiotics may or may not be needed.
Physicians have reported that MeMed BV results support or change clinical decision-making in a significant majority of cases, according to Beckman Coulter. The company also says validation studies have shown strong performance as an aid in excluding bacterial infection.
Evaluating suspected infection in young children can be especially challenging because symptoms are often nonspecific and patients may be unable to describe their symptoms or medical history. The assay is cleared for children as young as 90 days.
Potential Effects on Antibiotic Use and Costs
Beckman Coulter points to published and real-world data suggesting the test may help reduce unnecessary antibiotic use and health care resource utilization. Published health-economic modeling in patients with community-acquired pneumonia estimated about 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 emergency department sepsis alert order, showed an estimated $1,790 reduction in cost per patient. The reduction was primarily due to avoidable admissions among patients with unlikely bacterial sepsis. The findings were presented at the Society for Academic Emergency Medicine annual meeting. According to the study disclosure, MeMed funded research assistants and provided tests.
“This milestone significantly expands access to host-response diagnostics in one of the world’s largest healthcare markets,” says Eran Eden, CEO and co-founder of MeMed, in a release. “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.”
Beckman Coulter says the assay offers a scalable approach to timely diagnostic information that also supports broader public health efforts to combat antibiotic resistance.
