Molecular diagnostics company Nanosphere, Inc., has received clearance from the U.S. Food and Drug Administration (FDA) for its Verigene Gram-Negative Blood Culture (BC-GN) Test and submitted its Verigene Enteric Pathogens Test for gastrointestinal infections to the FDA.
Verigene BC-GN is a rapid in vitro diagnostic test that identifies a broad spectrum of gram-negative bacteria that cause bloodstream infections and determine resistance to commonly used antibiotics up to two to three days faster than conventional identification methods. Among the critical genetic markers of antibiotic resistance identified by Verigene BC-GN are five genes which can identify carbapenem-resistant Enterobacteriaceae (CRE), so-called “superbugs” that are resistant to nearly all available antibiotics. The 14-target Verigene BC-GN test joins Nanosphere’s currently marketed Verigene BC-GP Test, which detects a broad spectrum of gram-positive bacteria and the antimicrobial resistance genes associated with methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).
Verigene Enteric Pathogens Test is designed to help hospitals more efficiently and cost-effectively diagnose patients with community-acquired diarrhea, typically caused by consumption of contaminated food or water containing bacterial, viral or parasitic gastrointestinal pathogens. Since symptoms alone are often not sufficient to make treatment decisions, rapid identification of the cause of community-acquired diarrhea is critical for optimal patient management. Learn more about the Verigene system.
