Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Cepheid Announces Chlamydia and N. gonorrhoeae Test Categorized 'Moderate Complexity' by FDA

Published: Tuesday, January 22, 2013
Last Updated: Tuesday, January 22, 2013
Bookmark and Share
The test runs on Cepheid's GeneXpert® Systems and is the first and only molecular CT/NG test to be categorized as Moderately Complex.

Cepheid announced the U.S. Food & Drug Administration (FDA) has categorized Cepheid's Xpert® CT/NG test as 'Moderate Complexity' under the Clinical Laboratory Improvement Amendments (CLIA). Xpert CT/NG is a qualitative in vitro molecular diagnostic test for the detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). The test runs on Cepheid's GeneXpert® Systems and is the first and only molecular CT/NG test to be categorized as Moderately Complex. The Moderately Complex categorization will now allow the accuracy benefits of molecular diagnostics to be realized over a broader testing universe.

"In a recent study of 23 developed countries by the Institute of Medicine and the National Research Council, the U.S. was found to have the highest rates of Sexually Transmitted Diseases among youths," said John Bishop, Cepheid's Chief Executive Officer. "Now accessible to more than 20,000 Moderately Complex U.S. labs and 7,000 High Complexity U.S. labs, Xpert CT/NG becomes an important new weapon in reducing STD rates as clinicians can test, consult with, and treat their patients on a more timely basis."

"The classification of Xpert CT/NG by the FDA as 'Moderate Complexity' is a breakthrough for sexual health and STD prevention. The large number of Moderate Complexity point-of-care laboratories that exist in U.S. hospitals and clinics can now offer rapid, highly accurate and private same-day STD testing," said Jeffrey D. Klausner, MD, MPH, Professor of Medicine, UCLA-David Geffen School of Medicine. "Public health officials need to work with providers to increase the availability of those tests. Faster STD detection and treatment could go a long way in stemming the continued epidemic of STDs in the United States."

Gonorrhea and Chlamydia are Sexually Transmitted Diseases. Both are easily treated when detected and managed quickly. Chlamydia remains the most common sexually transmitted bacterial infection in the United States. While the CDC recommends annual testing for all sexually active women aged 25 and under, their most recent nationally representative estimate among this population found that only 38 percent of sexually active women were tested for chlamydia during the previous year.

Gonorrhea is the second most commonly reported bacterial infectious disease in the country. The CDC estimates that more than 700,000 Americans become infected with gonorrhea every year, yet fewer than half of these infections are diagnosed and reported to the CDC. Current testing protocols for Neisseria gonorrhoeae are often problematic due to cross-reactivity with other organisms, often requiring an additional confirmatory test. These delays and coordination issues can significantly hamper communication and consultation, leaving both patients and their partners uninformed and untreated.

The categorization of commercially marketed in vitro diagnostic tests under CLIA is the responsibility of the FDA. This categorization includes the process of assigning commercially marketed in vitro diagnostic test systems to one of three CLIA regulatory categories:

•    waived tests
•    tests of moderate complexity
•    tests of high complexity

Cepheid was the first company to receive a 'Moderate Complexity' categorization for a nucleic acid test and Xpert CT/NG is the 12th Cepheid test to be categorized as such.


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 3,000+ scientific posters on ePosters
  • More Than 4,400+ 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 TechnologyNetworks.com 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.

Related Content

Cepheid Announces Partnership with Medline
Company has announced partnership with Medline for the distribution of the GeneXpert® System.
Saturday, April 23, 2016
Cepheid's Next-Gen MRSA Test Gets CE Mark
The number one, on-demand molecular test for MRSA colonization is now improved.
Tuesday, April 05, 2016
Cepheid Receives FDA Clearance for Xpert Norovirus
Xpert Norovirus is the first on-demand molecular test for detection of Norovirus, providing accurate Norovirus detection in as little as one hour.
Monday, December 01, 2014
Cepheid Awarded Funding To Develop Xpert Ebola
With Funding from the Paul G. Allen Family Foundation and the Bill & Melinda Gates Foundation, Cepheid expects to deliver prototype in as little as eight weeks.
Friday, November 14, 2014
Cepheid Reports Q4 Full Year 2013 Results
Company reports revenues for Q4 2013 of $113.3 million.
Monday, February 03, 2014
Cepheid to Sponsor BASHH 2013 Spring Meeting
Cepheid is helping to bring together prominent scientists and clinicians from across the UK at the British Association for Sexual Health and HIV (BASHH) 2013 Spring Meeting.
Tuesday, May 07, 2013
Cepheid and FIND Announce Collaboration to Develop HIV Viral Load Test
Company’s collaborate to accelerate the development of a rapid molecular test for the measurement of human immunodeficiency virus viral load.
Wednesday, February 09, 2011
Cepheid Announces European Release of Test for Simultaneous Detection of MTB and Resistance to Rifampicin
Company’s GeneXpert® system capabilities enable new TB diagnostic tool.
Monday, May 04, 2009
Cepheid's Xpert™ MRSA PCR-Based Drug Resistant Test Receives FDA Clearance
The US FDA has cleared a Cepheid’s PCR test which is designed to detect nosocomial and antibiotic-resistant strain of Staphylococcus in over one hour.
Thursday, April 19, 2007
Cepheid Acquires Sangtec Molecular for $27 Million
Cepheid expands its PCR based molecular diagnostics product area by acquiring Sangtec Molecular Diagnostics AB from the Nycomed-owned ALTANA Pharma AG.
Friday, February 16, 2007
Scientific News
Computational Model Finds New Protein-Protein Interactions
Researchers at University of Pittsburgh have discovered 500 new protein-protein interactions (PPIs) associated with genes linked to schizophrenia.
Experimental Drug Cancels Effect from Key Intellectual Disability Gene
A University of Wisconsin—Madison researcher who studies the most common genetic intellectual disability has used an experimental drug to reverse — in mice — damage from the mutation that causes the syndrome.
MicroRNA Pathway Could Lead to New Avenues for Leukemia Treatment
Cancer researchers at the University of Cincinnati have found a particular signaling route in microRNA (miR-22) that could lead to targets for acute myeloid leukemia, the most common type of fast-growing cancer of the blood and bone marrow.
Bioreactors Ready for the Big Time
Bioreactors are passive filtration systems that can reduce nitrate losses from farm fields.
Analysis of Dog Genome will Provide Insight into Human Disease
An important model in studying human disease, the non-coding RNA of the canine genome is an essential starting point for evolutionary and biomedical studies – according to a new study led by The Genome Analysis Centre (TGAC).
‘Mini-Brains’ to Study Zika
Novel tool expected to speed research on brain and drug development.
Finding Factors That Protect Against Flu
A clinical trial examining the body’s response to seasonal flu suggests new approaches for evaluating the effectiveness of seasonal flu vaccines.
New Insights into Gene Regulation
Researchers have solved the three-dimensional structure of a gene repression complex that is known to play a role in cancer.
Controlling RNA in Living Cells
Modular, programmable proteins can be used to track or manipulate gene expression.
Common Class of Cancer Drugs May Not Lead to Cognitive Decline
UCLA study refutes 2015 research suggesting anthracyclines could cause memory loss, other impairments.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
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
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,400+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!