Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
 
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
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 2,500+ scientific posters on ePosters
  • More than 3,800+ 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 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
Scientific News
‘Mutation-Tracking’ Blood Test for Breast Cancer
Scientists have developed a blood test for breast cancer able to identify which patients will suffer a relapse after treatment, months before tumours are visible on hospital scans.
Common ‘Heart Attack’ Blood Test May Predict Future Hypertension
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressure.
Poor Survival Rates in Leukemia Linked to Persistent Genetic Mutations
For patients with an often-deadly form of leukemia, new research suggests that lingering cancer-related mutations – detected after initial treatment with chemotherapy – are associated with an increased risk of relapse and poor survival.
'Fountain of Youth' Protein Points to Possible Human Health Benefit
Patients with higher blood levels of growth factor have lower risk of cardiovascular problems.
Signature of Microbiomes Linked to Schizophrenia
Studying microbiomes in throat may help identify causes and treatments of brain disorder.
Imaging Software Could Speed Breast Cancer Diagnosis
Technology could improve access to diagnostic services in developing countries.
The Changing Tides of the In Vitro Diagnostics Market
With the increasing focus in personalized medicine, diagnostics plays a crucial role in patient monitoring.
Data Mining DNA For Polycystic Ovary Syndrome Genes
A new Northwestern Medicine genome-wide association study of PCOS – the first of its kind to focus on women of European ancestry – has provided important new insights into the underlying biology of the disorder.
Algorithm Interprets Breathing Difficulties to Aid in Medical Care
Researchers from North Carolina State University have developed an efficient algorithm that can interpret the wheezing of patients with breathing difficulties to give medical providers information about what’s happening in the lungs.
Researchers Develop qPCR Prognosis Test for NSCLC Patients
A nine-gene molecular prognostic index (MPI) for patients with early-stage non-small cell lung cancer (NSCLC) was able to provide accurate survival stratification and could potentially inform the use of adjuvant therapy in patients struggling with the disease.
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!