Industry News

Our news page will keep you informed of press releases and news articles on rapid and alternative microbiological method technologies and updates from technology suppliers.

Please click here to submit your news.

Nanosphere Receives FDA Clearance for Gram-Negative Blood Culture Test and Submits New Enteric Pathogen Test

Nanosphere, Inc., a company enhancing medicine through targeted molecular diagnostics, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Verigene® Gram-Negative Blood Culture (BC-GN) Test and has submitted its Verigene Enteric Pathogens Test for gastrointestinal infections to the FDA.

Verigene BC-GN, which received clearance from the FDA, is a rapid in vitro diagnostic test that identifies a broad spectrum of gram-negative bacteria that cause bloodstream infections and determines resistance to commonly used antibiotics up to two to three days faster than conventional identification methods.

Bloodstream infections can lead to sepsis, a primary cause of death resulting in over $20 billion in healthcare costs in the U.S. annually. Infections complicated by antibiotic resistance are especially difficult to treat and are associated with greater mortality. 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. In a recent landmark report, the Centers for Disease Control and Prevention (CDC) assigned an urgent hazard level to CRE, indicating they pose an immediate public health threat and require urgent and aggressive action.

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).

"Antimicrobial resistance poses a significant threat and significantly affects how we practice medicine, as the availability of viable antibiotics to treat these life-threatening infections is decreasing," said Richard Thomson, Ph.D., director of clinical microbiology at NorthShore University HealthSystem. "Knowing what bacterium is responsible for the infection and which antibiotics it's resistant to is an important step toward ensuring that our patients are receiving targeted therapy and that we are not using any unnecessary antibiotics."

Verigene Enteric Pathogens Test, which was recently submitted by Nanosphere to the FDA, 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.

Most cases of community-acquired diarrhea are self-resolving and not life-threatening, yet gastrointestinal infections are associated with 3.7 million emergency department visits, 1.3 million inpatient hospitalizations and more than $6 billion in healthcare costs per year in the U.S.

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 and can lead to fewer hospital admissions, reduced use of inappropriate or unnecessary antibiotics and workflow benefits to laboratories.

Post a Comment

Previous Post Next Post

Contact Form