- Diagnostic Turnaround Time: Generates quantified probability score within 15 minutes；Validated on Beckman Coulter DxI 9000 analyzers
- Approved Clinical Cohort: Adult and pediatric patients aged 90 days and older
- Public Health Stewardship: Resolves diagnostic ambiguity between bacteria and viruses；Curbs empirical antimicrobial overuse and halts sepsis drift
Assay uses machine learning to decode host immune response
The United States Food and Drug Administration (FDA) has granted 510(k) clearance to the Access MeMed BV assay, an automated in vitro diagnostic test developed through a clinical collaboration between Beckman Coulter Diagnostics and medical technology innovator MeMed. The regulatory authorization marks the first time an automated, host-response immunoassay capable of differentiating between bacterial and viral infections in as little as 15 minutes has been cleared for widespread integration across high-throughput clinical laboratory analyzers in the United States.
The Access MeMed BV assay resolves this diagnostic friction by shifting focus from direct microbial detection to decoding the host’s immune response. Utilizing machine learning algorithms, the test simultaneously quantifies three circulating immune-response proteins present in serum or plasma: Tumor Necrosis Factor-Related Apoptosis-Inducing Ligand (TRAIL), Interferon Gamma-Induced Protein-10 (IP-10), and C-Reactive Protein (CRP). The platform computes a composite probability score ranging from 0 to 100, providing clinicians with definitive probabilistic guidance regarding the likelihood of a bacterial infection versus a viral infection.
Rapid 15-minute testing aids triage and antimicrobial stewardship
Health economists and clinical pathology specialists underscored that the availability of rapid, 15-minute host-response testing on automated hospital laboratory analyzers represents a vital breakthrough for emergency triage and diagnostic stewardship. By providing emergency department physicians with actionable, objective diagnostic data before initiating antimicrobial therapies, hospitals can significantly curb the emergence of multi-drug resistant superbugs while optimizing acute patient flow. The FDA’s clearance of the Access MeMed BV assay establishes a new clinical paradigm in acute febrile diagnostic management, bridging the gap between clinical urgency and targeted antimicrobial stewardship.
Additionally, hospital administrators observed that integrating rapid diagnostic panels significantly reduces unnecessary bed occupancy and streamlines emergency room operations during seasonal viral surges, delivering quantifiable operational cost savings across regional healthcare delivery networks.
