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
Sign In
Advertise with Us
PURITAN MEDICAL

Download Mobile App




NuQ Blood Assay CE-Marked for Colorectal Cancer Detection

By LabMedica International staff writers
Posted on 04 Oct 2015
Print article
Image: Nucleosomics Technology: The DNA in every cell is wound around protein complexes in a beads-on-a-string structure. Each bead is called a nucleosome. When cells die, the body breaks the DNA string up into individual nucleosomes which are released into the blood (Photo courtesy of VolitionRx Limited).
Image: Nucleosomics Technology: The DNA in every cell is wound around protein complexes in a beads-on-a-string structure. Each bead is called a nucleosome. When cells die, the body breaks the DNA string up into individual nucleosomes which are released into the blood (Photo courtesy of VolitionRx Limited).
A blood-based diagnostic assay for detection of colorectal cancer has received Conformité Européenne (CE) marking, which enables European Clinical Use/Sale in 33 Countries with nearly 600 million people.

The test utilizes a proprietary technology platform that identifies and analyses fragments of chromosomes, called nucleosomes, circulating within the blood for the presence of epigenetic cancer signals.

The announcement of the CE marking follows the presentation earlier this month of interim data of a 4,800-subject trial, which demonstrated that the NuQX001S (VolitionRx Limited; Namur Belgium) blood tests detected 81% of colorectal cancers at 78% specificity equally well for both for early- and late-stage cancers, as well as 63% of potentially pre-cancerous adenomas and 67% of high-risk adenomas, the most likely to become cancerous. The NuQ test utilizes the Company's proprietary Nucleosomics technology platform.

The Company plans to offer a commercial test consisting of a panel of four to six individual enzyme-linked immunosorbent assays (ELISA); it is currently conducting ongoing clinical trials and following the CE compliance process on further assays in order to refine the make-up of the panel and produce the highest accuracy detection rates. VolitionRx anticipates launching its panel of CE-Marked assays for clinical use in Europe during 2016.

Gaetan Michel, PhD, CEO of Belgian Volition SA, commented, “Our recent results showed that a panel test of four NuQ assays successfully detected both early- and late-stage cancer well, which is critical for improving five-year survival rates. Achieving the first CE mark for our NuQX001S diagnostic assay demonstrates VolitionRx's clear commitment to deliver these first-class quality products to physicians and their patients.”

Cameron Reynolds, MBA, president and CEO of VolitionRx, said, “We are now able to sell this assay clinically in the 28 member states of the European Union, as well as Switzerland, Turkey, Iceland, Norway, and Liechtenstein, an area with a total population of nearly 600 million people including over 150 million of screening age.”

Related Links:

VolitionRx Limited


Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Specimen Collection & Transport
POCT Fluorescent Immunoassay Analyzer
FIA Go
Gold Member
Reagent Reservoirs
Reagent Reservoirs

Print article

Channels

Clinical Chemistry

view channel
Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)

POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more

Molecular Diagnostics

view channel
Image: The study showed the blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90% (Photo courtesy of Guardant Health)

Blood Test Shows 83% Accuracy for Detecting Colorectal Cancer

Colorectal cancer is the second biggest cause of cancer deaths among adults in the U.S., with forecasts suggesting 53,010 people might die from it in 2024. While fewer older adults are dying from this... Read more

Hematology

view channel
Image: The Gazelle Hb Variant Test (Photo courtesy of Hemex Health)

First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy

Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's... Read more

Microbiology

view channel
Image: The new platform is designed to perform blood-based diagnoses of nontuberculosis mycobacteria (Photo courtesy of 123RF)

New Blood Test Cuts Diagnosis Time for Nontuberculous Mycobacteria Infections from Months to Hours

Breathing in nontuberculous mycobacteria (NTM) is a common experience for many people. These bacteria are present in water systems, soil, and dust all over the world and usually don't cause any problems.... Read more

Industry

view channel
Image: These new assays are being developed for use on the recently introduced DxI 9000 Immunoassay Analyzer (Photo courtesy of Beckman Coulter)

Beckman Coulter and Fujirebio Expand Partnership on Neurodegenerative Disease Diagnostics

Beckman Coulter Diagnostics (Brea, CA, USA) and Fujirebio Diagnostics (Tokyo, Japan) have expanded their partnership focused on the development, manufacturing and clinical adoption of neurodegenerative... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.