Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us

Download Mobile App




Cepheid Obtains CE Marking for Same-Day Diagnostic Equipment

By LabMedica International staff writers
Posted on 30 May 2012
Cepheid (Sunnyvale, CA, USA), a molecular diagnostics company that develops and manufactures molecular systems and tests, announced that both Xpert CT/NG and Xpert CT have received CE marking, enabling the products to be shipped to Europe immediately.

The products, which run on Cepheid's GeneXpert System, are in vitro (IV) molecular diagnostic tests that detect and differentiate Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), two sexually transmitted infections (STIs). More...


Gonorrhoeae and chlamydia are easily treated once diagnosed and managed. However, according to the European Centers for Disease Control and Prevention (ECDC), the rate of infection for both infections has increased during the last decade.

Current testing materials for both gonorrhoeae and chlamydia are slow and problematic, oftentimes requiring additional tests to confirm diagnosis. The delays and inaccuracies in testing have hampered communication between patients and doctors, leaving patients unaware of their infections and unable to procure treatment.

Cepheid’s new products provide diagnostic results in less than 90 minutes, enabling same-day patient consultation and treatment options.

"We are bringing to market a true next-generation molecular diagnostic product for detection of CT/NG a test designed from the ground up to provide unprecedented accuracy, ease of use, and results availability," said John Bishop, CEO, Cepheid. "We expect these innovative products to deliver new levels of confidence to clinicians making same-day decisions in consulting with, and treating, their patients the critical first step in effectively managing these diseases."

Xpert CT/NG will be immediately available as a CE-marked product and is expected to become available in the United States in late 2012.


Related Links:

Cepheid


New
Gold Member
Automatic Chemiluminescence Immunoassay Analyzer
Shine i2000
Collection and Transport System
PurSafe Plus®
Rapid Molecular Testing Device
FlashDetect Flash10
Gram-Negative Blood Culture Assay
LIAISON PLEX Gram-Negative Blood Culture Assay
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Molecular Diagnostics

view channel
Image: LungCanSeek demonstrated an overall sensitivity of 83.5% and specificity of 90.3% in detecting lung cancer (Photo courtesy of AdobeStock)

New Blood Test Offers Affordable and Accurate Early Detection of Lung Cancer

Lung cancer remains the leading cause of cancer-related deaths worldwide, largely because most cases are diagnosed at advanced stages when treatment options are limited. Early detection significantly improves... Read more

Hematology

view channel
Image: New evidence shows viscoelastic testing can improve assessment of blood clotting during postpartum hemorrhage (Photo courtesy of 123RF)

Viscoelastic Testing Could Improve Treatment of Maternal Hemorrhage

Postpartum hemorrhage, severe bleeding after childbirth, remains one of the leading causes of maternal mortality worldwide, yet many of these deaths are preventable. Standard care can be hindered by delays... Read more

Immunology

view channel
Image: The TriVerity IVD test includes the TriVerity cartridge and the Myrna instrument (Photo courtesy of Inflammatix)

Blood-Based Immune Cell Signatures Could Guide Treatment Decisions for Critically Ill Patients

When a patient enters the emergency department in critical condition, clinicians must rapidly decide whether the patient has an infection, whether it is bacterial or viral, and whether immediate treatment... Read more

Industry

view channel
Image: The collaboration supports clinical validation and regulatory submissions of the new T1D 4-plex assay on Revvity’s GSP instrument (Photo courtesy of Revvity)

Revvity and Sanofi Collaborate on Program to Revolutionize Early Detection of Type 1 Diabetes

Type 1 diabetes (T1D) is a lifelong autoimmune condition in which the immune system destroys the pancreas’s insulin-producing beta cells, leading to dependence on insulin therapy. Early detection is critical... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.