Molecular diagnostics company Nanosphere, Inc., has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the bacterial portion of its Verigene Enteric Pathogens Nucleic Acid Test (EP). Clinical studies for the full panel, including two additional viral targets, have been completed and the company expects clearance of the full EP panel. The company will submit additional data to the FDA for the two viral targets to be included on Verigene EP imminently.
Verigene EP is an automated in vitro diagnostic test that simultaneously identifies a broad panel of common community-acquired pathogenic enteric bacteria and genetic virulence markers directly from a stool sample, two to three days faster than conventional identification methods. Since symptoms of diarrhea alone are insufficient to make treatment decisions, rapid identification of the bacterial or viral cause of diarrhea is critical for optimal patient management, limiting the prescription of inappropriate or unnecessary antibiotics.
The Verigene EP Test joins Nanosphere's currently marketed Verigene Clostridium difficile Nucleic Acid Test (CDF), which identifies toxigenic C. difficile and differentiates the 027 hypervirulent strain for epidemiological purposes. C. difficile infections are most commonly associated with use of antibiotics and are responsible for 250,000 hospitalizations and at least 14,000 deaths per year in the United States.
“FDA clearance of Verigene EP further strengthens our portfolio of multiplexed molecular gastrointestinal tests and expands our ability to deliver clinical, economic and workflow benefits to those hospitals and laboratories which have adopted our Verigene System,” says Michael McGarrity, Nanosphere's president and chief executive officer. “Our menu offerings addressing community and healthcare-acquired infections enable our customers to run the most appropriate test for each patient based on their respective clinical presentation and health history.” Learn more about the Verigene system.Read more