FDA clears additional viral targets on Verigene Enteric Pathogens Test

Nanosphere, Inc., provider of targeted molecular diagnostics, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Verigene Enteric Pathogens Nucleic Acid Test (EP), which now includes additional viral targets, as well as the bacterial and toxigenic targets cleared by the FDA this summer.

According to Nanosphere representatives, Verigene EP is a rapid, easy-to-use, and cost-effective alternative to traditional stool diagnostics. The company believes it has the potential to deliver clinical, economic, and workflow benefits to hospitals and laboratories. Verigene EP is Nanosphere’s second FDA-cleared test in the area of gastroenteritis, joining the currently marketed VerigeneClostridium difficile Nucleic Acid Test (CDF), which identifies toxigenicC. difficile and differentiates the 027 hypervirulent strain for epidemiological purposes.

“Rapid diagnostic tests that accurately detect the organisms that cause diarrheal illness have the ability to improve physician decisions regarding patient management,” says Paul A. Granato, PhD, D(ABMM), Director of Microbiology and Scientific Director of Clinical Microbiology at Laboratory Alliance, whose laboratory participated in the Verigene EP clinical trial. “In addition to potentially reducing use of unnecessary or inappropriate antibiotics, these tests can help optimize laboratory staff and budgetary resources by reducing the time and costs associated with working up both negative and positive stool specimens.”

Nanosphere’s menu includes five multiplex molecular diagnostic tests performed using the automated, sample-to-result Verigene System that target infections of the bloodstream, respiratory tract, and gastrointestinal tract. They include the Verigene Gram-Positive Blood Culture Test (BC-GP), the Verigene Gram-Negative Blood Culture Test (BC-GN), the Verigene Respiratory Virus Plus Test (RV+), Verigene CDF (each of which is FDA-cleared and CE-marked), and now Verigene EP. Nanosphere anticipates CE marking of Verigene EP in early 2015. Learn more about the Verigene Enteric Pathogens Test.