Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>News>This Article

Nanosphere Receives FDA Clearance for C. difficile Test

Published: Wednesday, December 12, 2012
Last Updated: Wednesday, December 12, 2012
Bookmark and Share
Comprehensive sample-to-result test detects potentially deadly C. difficile and identifies 027 hypervirulent strain.

Nanosphere, Inc. announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance permitting marketing of its C.difficile test on the automated sample-to-result Verigene® System.

The C. difficile test expands Nanosphere’s infectious disease test capabilities.  C. difficile infection is a cause of diarrhea that can lead to colitis, other serious intestinal conditions and death.  In less than two hours, the C. difficile test detects the toxin A and B gene sequences of C. difficile and identifies the PCR ribotype 027 strain which is associated with increased severity of disease and used for infection control.  Early and accurate diagnosis of C. difficile infections is critical in both the proper treatment of infected patients and subsequent implementation of isolation and containment procedures to prevent further spread of the infection.

“The C. difficile test provides Nanosphere’s customers with a valuable tool to fight these deadly and costly infections,” said Bill Moffitt, Nanosphere’s Chief Executive Officer.  “With four new products cleared by the FDA in the last 12 months, we are pleased to lead the market in providing a comprehensive suite of tests that can improve patient outcomes and reduce healthcare spending” Moffitt stated.

The sample-to-result test automates the steps of bacterial DNA extraction, amplification, hybridization and target detection on the Verigene System.  The ease-of-use and rapid turnaround time of the test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing.

The C. difficile test complements Nanosphere’s broadening menu of infectious disease tests including:

•    Gram-Positive Blood Culture test (BC-GP) to detect bacteria, including antibiotic resistance markers, that may cause bloodstream infections (510(k) cleared; CE-Mark)
•    Respiratory Virus Plus test (RV+)  to detect multiple respiratory viruses which cause respiratory tract infections (510(k) cleared; CE-Mark)
•    Enteric Pathogens test (EP) to detect and multiple bacteria, viruses and toxin genes which cause gastrointestinal infections (In Clinical Trials )
•    Gram-Negative Blood Culture test (BC-GN) to detect bacteria, including antibiotic resistance markers, that may cause bloodstream infections (In Clinical Trials)

Nanosphere plans to commercialize the enteric pathogens and gram-negative tests in 2013 following receipt of the necessary regulatory approvals.

About C. difficile Infections

C. difficile strikes nearly 500,000 Americans annually and is linked in hospital records to more than 30,000 deaths per year in the United States.  The elderly, immunocompromised, and those recently treated with antibiotics have the greatest risk of acquiring C. difficile infections.  Around 75% of C. difficile infections are acquired in hospitals or nursing homes, with transmission to patients occurring via the hands of healthcare workers or contact with contaminated surfaces2.  Community-acquired cases of C. difficile, however, are on the rise.  The increase in severity of C. difficile infections over the past decade is likely linked to the emergence of the BI/NAP1/027 hypervirulent strain, with C. difficile related deaths increasing 400% over that timespan.  “Hospital billing data collected by the Federal Agency for Healthcare Research and Quality shows that more than 9% of C. diff-related hospitalizations end in death — nearly five times the rate for other hospital stays,” according to a recent USA TODAY investigation1.  Currently, the federal government does not have a system in place to track antibiotic use in healthcare facilities, and there is no Medicare and Medicaid penalty for facilities with high C. difficile rates.  A new C. difficile reporting rule is scheduled to be implemented in 2013 that will now include reporting in nursing homes and rehabilitation centers in addition to hospitals in attempts to combat C. difficile spread.

Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,100+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Scientific News
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Transgenomic, Precipio Diagnostics Merger
Merger will creates a robust diagnostic platform focused on improving accuracy of cancer diagnoses.
3D-Printing in Science: Conference Co-Staged with LABVOLUTION
LABVOLUTION 2017 will have an added highlight of a simultaneous conference, "3D-Printing in Science".
Analysing 10,000 Cells Simultaneously
New techniquethat traps 10,000 cells on a single chip has potential for cancer screening for individuals.
$1M NIH Grant to Refine PCR Based Cancer Test
Researchers at Cornell University, Weill Cornell Medicine, the University of California, San Francisco, and the Infectious Diseases Institute in Kampala, Uganda, recieve a four-year, $1 million grant to hone technology for a quick, in-the-field diagnosis of Kaposi's sarcoma — a cancer frequently related to HIV infections.
Genetic Tug of War Before Cells Decide Fate
Researchers report that as developing blood cells are triggered by genetic signals firing on and off, a 'tug of war' occurs.
Linkage Biosciences Awarded NHS Contract
Comapny announces that it has been awarded a four-year contract by NHS Blood and Transplant (NHSBT) in the UK for implementation of the LinkSeq™ Real-Time PCR HLA typing product.
Understanding Tumor Evolution
Study provides insight into tumor evolution; may point to improved diagnosis and treatment.
Frankfurter Fraud: Finding Out What’s In Your Hot Dog
Scientists have developed a technique to test the meat content of Frankfurters.
How Cloud Connectivity Can Combat the Reproducibility Crisis
This infographic explains the reproducibility crisis, and how cloud connectivity can help overcome this problem.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,100+ scientific videos