Clinical studies for the full panel, including two additional viral targets, have been completed and the Company expects clearance of the full EP panel.
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 the time- and labor-intensive conventional identification methods.
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.
The company will submit additional data to the FDA for the two viral targets to be included on Verigene EP imminently.
Nanosphere president and CEO Michael McGarrity said that the FDA clearance of Verigene EP further strengthens the company’s portfolio of multiplexed molecular gastrointestinal tests and expands its ability to deliver clinical, economic and workflow benefits to those hospitals and laboratories which have adopted our Verigene system.
"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," McGarrity added.
Nanosphere’s menu of infectious disease tests are performed using the automated, sample-to-result Verigene system.
