Beckman Coulter Diagnostics has received U.S. FDA clearance of the Access MeMed BV assay, a rapid, automated host-response blood test that helps clinicians distinguish bacterial from viral infections in adult and pediatric patients.

The Access MeMed BV assay measures three immune-response proteins, TRAIL, IP-10 and CRP, in serum or plasma from adult and pediatric patients as young as 90 days old 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.

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, 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.

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.

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

Visit Beckman Coulter for more information