FDA Clears Additional Viral Targets on Verigene Enteric Pathogens Test
Nanosphere, Inc. has received 510(k) clearance from the 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 FDA earlier this summer.
Verigene EP is a rapid, easy-to-use and cost-effective alternative to traditional stool diagnostics that the company believes has the potential to deliver clinical, economic and workflow benefits to hospitals and laboratories. The test can detect Campylobacter Group, Salmonella spp., <em>Shigella</em> spp., Vibrio Group, Yersinia enterocolitica, Shiga Toxins (stx1 and stx2), Norovirus and Rotavirus.
Verigene EP is Nanosphere's second FDA-cleared test in the area of gastroenteritis, joining the currently marketed Verigene Clostridium difficile Nucleic Acid Test (CDF), which identifies toxigenic C. difficile and differentiates the 027 hypervirulent strain for epidemiological purposes.
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.
Tags: Clostridium difficile, Rotavirus, Norovirus, Stool samples
Date Published: October 13, 2014
Source article link: Nanosphere, Inc. » company contact details
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