Beckman Coulter Diagnostics said it has received FDA clearance for the Access MeMed BV assay, a rapid host-response blood test that helps clinicians distinguish bacterial from viral infections in adult and pediatric patients.
Available on the DxI 9000 and Access 2 immunoassay analyzers already installed in hospital laboratories nationwide, the new assay provides 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, a provider of host-response diagnostics, 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.
"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," said Melissa Naiman, Senior Director, Medical & Scientific Affairs, Acute Care at Beckman Coulter Diagnostics. "That added confidence can be particularly valuable when deciding whether antibiotics are appropriate, helping support responsible antibiotic use while ensuring patients, including children as young as 90 days old, who need antibiotics receive the care they need."
