Globe Newswire
October 13, 2014: 08:00 AM ET
NORTHBROOK, Ill., Oct. 13, 2014 (GLOBE NEWSWIRE) -- Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, today announced it 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 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.
"Rapid diagnostic tests that accurately detect the organisms that cause diarrheal illness have the ability to improve physician decisions regarding patient management," said 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."
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.
"The feedback we've received from the medical community regarding our approach to designing Verigene EP to provide clinically actionable results for common community-acquired gastrointestinal infections has been very encouraging," said Michael McGarrity, Nanosphere's president and chief executive officer. "We anticipate that the addition of Verigene EP to our infectious disease test menu will provide additional value to our customers and patients."
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.
About the Verigene® System
The Verigene System uses Nanosphere's core proprietary gold nanoparticle chemistry to offer highly sensitive, highly specific molecular diagnostic results through low-cost multiplexing. The Verigene System rapidly and accurately detects infectious pathogens and drug resistance markers by targeting conserved genetic regions of a bacterium or virus. Currently, the multiplexed Verigene tests target infections of the bloodstream, respiratory tract and gastrointestinal tract. The information gathered from Verigene test results enables clinicians to make informed patient treatment decisions more quickly, which may result in improved patient outcomes, reduced costs, optimized antibiotic therapy and reduced spread of antibiotic resistance. |
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