FDA Clears Bacterial Portion of Nanosphere’s Verigene Enteric Pathogens Nucleic Acid Test

Northbrook, Ill.-based Nanosphere Inc., a molecular diagnostics company, has earned 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 Verigene system uses Nanosphere’s core proprietary gold nanoparticle chemistry to offer highly sensitive, highly specific molecular diagnostic results through low-cost multiplexing. The system is designed to rapidly and accurately detects infectious pathogens and drug resistance markers by targeting conserved genetic regions of a bacterium or virus. Currently, the multiplexed Verigene assays target infections of the blood, respiratory tract and gastrointestinal tract. According to the company, 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.

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, reportedly two to three days faster than the time- and labor-intensive conventional identification methods.

Diarrhea caused by bacterial and viral infection represents a significant healthcare burden in the U.S. While most cases of community-acquired diarrhea are self-resolving and not life-threatening, gastrointestinal infections in the U.S. are associated with 3.7 million emergency department visits, 1.3 million inpatient hospitalizations and more than $6 billion in healthcare costs per year.

Since symptoms 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 U.S., and were recently highlighted by the Centers for Disease Control and Prevention as a healthcare-acquired infection posing an urgent health threat in the United States.

Nanosphere will submit additional data to the FDA for the two viral targets to be included on Verigene EP imminently.

“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,” said President and CEO Michael McGarrity. “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.”

Nanosphere’s menu of infectious disease tests are performed using the automated, sample-to-result Verigene System. Its ease of use and on-demand workflow makes Verigene a viable diagnostic platform for use in both hospital-based and reference laboratories across the country, regardless of size.