We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
LGC Clinical Diagnostics

Download Mobile App




CE Mark Granted to Urine Test for Bladder Cancer

By LabMedica International staff writers
Posted on 12 Apr 2017
The new test performed with superior results over all other non-invasive tests examined in a European multi-center study for bladder cancer monitoring.

The European Union’s CE Mark was granted to Nucleix’s (Rehovot, Israel) Bladder EpiCheck test, aimed to help urologists to better monitor their bladder cancer patients. More...
Bladder EpiCheck is a urine test that includes a panel of 15 proprietary biomarkers that are multiplexed in a real-time PCR analysis.

This regulatory approval follows the completion of a multi-center, prospective, and blinded clinical study that was performed in leading urology centers in Europe, with over 400 patients recruited in their first year of follow up. The study compared Bladder EpiCheck to the current gold standard follow up sequence (cystoscopy, cytology, and pathology for the positives). The Bladder EpiCheck results showed 99% Negative Predictive Value (NPV, excluding Ta-LG patients), 92% sensitivity (excluding Ta-LG patients), and 88% Specificity. Nucleix presented the results during the European Association of Urology (EAU) annual meeting (March 24-28, London, UK).

"These are important milestones for bladder cancer patients and urologists, adding an additional tool to their arsenal fighting bladder cancer," said Elon Ganor, Nucleix's co-founder and CEO, "These results show best-in-class performance for Bladder EpiCheck and will strongly support our launch in Europe."

Nucleix develops non-invasive molecular cancer diagnostic tests based on identification of subtle epigenetic changes in methylation patterns. Nucleix technology is based on a combination of a new biochemical assay in conjunction with sophisticated algorithms. The Nucleix pipeline includes a screening diagnostic blood test for early lung cancer detection.


Gold Member
Pharmacogenetics Panel
VeriDose Core Panel v2.0
Verification Panels for Assay Development & QC
Seroconversion Panels
New
Respiratory Infections Test
STANDARD Q Adeno Respi Ag Test
New
Glucose Tolerance Test
NERL Trutol
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

Clinical Chemistry

view channel
Image: The GlycoLocate platform uses multi-omics and advanced computational biology algorithms to diagnose early-stage cancers (Photo courtesy of AOA Dx)

AI-Powered Blood Test Accurately Detects Ovarian Cancer

Ovarian cancer ranks as the fifth leading cause of cancer-related deaths in women, largely due to late-stage diagnoses. Although over 90% of women exhibit symptoms in Stage I, only 20% are diagnosed in... Read more

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: The cancer stem cell test can accurately choose more effective treatments (Photo courtesy of University of Cincinnati)

Stem Cell Test Predicts Treatment Outcome for Patients with Platinum-Resistant Ovarian Cancer

Epithelial ovarian cancer frequently responds to chemotherapy initially, but eventually, the tumor develops resistance to the therapy, leading to regrowth. This resistance is partially due to the activation... Read more

Technology

view channel
Image: Scanning electron microscopy images showing 3D micro-printed Limacon-shaped whispering-gallery-mode microcavities with different amounts of deformation (Photo courtesy of A. Ping Zhang/PolyU)

Tiny Microlaser Sensors with Supercharged Biosensing Ability to Enable Early Disease Diagnosis

Optical whispering-gallery-mode microlaser sensors function by trapping light within tiny microcavities. When target molecules bind to the cavity, they induce subtle changes in the laser’s frequency, allowing... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.