Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Genesearch Breast Lymph Node assay detects breast cancer metastases with greater sensitivity

19.12.2006
Test provides surgeon with real-time information that may aid treatment decisions

Results from a prospective clinical study show that the GeneSearch™ Breast Lymph Node (BLN) Assay, a gene-based diagnostic test has greater sensitivity than traditional intra-operative methods of detecting the spread of breast cancer to the lymph nodes. In the study sponsored by Veridex, LLC, the GeneSearch™ BLN Assay demonstrated overall sensitivity at least 10 percentage points higher than traditional intra-operative tests. The data were presented today at the 29th Annual San Antonio Breast Cancer Symposium.

"These results indicate the potential advantage of the GeneSearch™ BLN Assay as an objective, standardized test that can assess breast cancer metastasis in the lymph nodes rapidly and with greater overall sensitivity than the current standard of care," said study investigator Peter W. Blumencranz, MD, FACS, Medical Director of Comprehensive Breast Health and Cancer Services, Morton Plant Mease Healthcare, and Medical Director of Moffitt Morton Plant Cancer Care, Clearwater, Florida. "This intra-operative test may provide surgeons with critical information that can help them optimize treatment decisions by allowing them to determine the scope of the surgery required."

In the study involving 416 evaluable patients across 11 clinical trial sites, sentinel lymph nodes were tested using the GeneSearch™ BLN Assay and current methods for assessing nodal tissue during surgery (frozen section (FS) or touch preparations (TP)). All nodes were sampled for permanent section hematoxylin/eosin (H&E), and most were also sampled for immunohistochemistry (IHC). The GeneSearch™ BLN Assay, FS and TP results were each compared to permanent section histology results to determine the performance of each method. The test was evaluated in terms of sensitivity and specificity, which measure how well the method correctly identifies nodes with and without clinically relevant metastases. Tests with lower sensitivity have a higher chance of false negatives, and tests with lower specificity have a higher chance of false positives.

In a head-to-head comparison with FS, overall sensitivity of the GeneSearchTM BLN Assay was 95.6 percent—10 percentage points greater than the overall sensitivity of FS (85.6 percent). In the same patient comparison, overall specificity of the GeneSearchTM BLN Assay remained high with a value of 94.3 percent compared to the 97.8 percent overall specificity of FS. In a head-to-head comparison with TP, overall sensitivity of the GeneSearchTM BLN Assay was 18 percentage points greater than the overall sensitivity of TP. In the same patient comparison, overall specificity of the GeneSearchTM BLN Assay remained at 100 percent for both the assay and TP.

"This innovative test has the potential to improve intra-operative pathology and surgical decision making, reduce the need for second surgeries, and thereby significantly improve patient care," said Mark Myslinski, General Manager, Veridex.

Sentinel lymph node biopsy (SLNB) is a widely used and accepted procedure in the management of breast cancer. SLNB involves removing the first (sentinel) lymph node that filters fluid from the breast, as this node is the most likely to contain cancer cells if the cancer has begun to spread. If there is no evidence of metastases in the sentinel node, it is unlikely that the cancer has spread to other nodes, and there may be no need for further surgery. Results of the GeneSearch™ BLN Assay can typically be reported during the operation within 30 to 40 minutes from the time the sentinel node is removed. The test outcomes are intended to be used to guide the decision to excise additional lymph nodes and to aid in patient staging.

The GeneSearch™ BLN Assay is CE marked to the In Vitro Diagnostic Device Directive in the European Union and became commercially available there on November 6, 2006.

Steve Dnistrian | EurekAlert!
Further information:
http://www.veridex.com

More articles from Studies and Analyses:

nachricht The personality factor: How to foster the sharing of research data
06.09.2017 | ZBW – Leibniz-Informationszentrum Wirtschaft

nachricht Europe’s Demographic Future. Where the Regions Are Heading after a Decade of Crises
10.08.2017 | Berlin-Institut für Bevölkerung und Entwicklung

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: The pyrenoid is a carbon-fixing liquid droplet

Plants and algae use the enzyme Rubisco to fix carbon dioxide, removing it from the atmosphere and converting it into biomass. Algae have figured out a way to increase the efficiency of carbon fixation. They gather most of their Rubisco into a ball-shaped microcompartment called the pyrenoid, which they flood with a high local concentration of carbon dioxide. A team of scientists at Princeton University, the Carnegie Institution for Science, Stanford University and the Max Plank Institute of Biochemistry have unravelled the mysteries of how the pyrenoid is assembled. These insights can help to engineer crops that remove more carbon dioxide from the atmosphere while producing more food.

A warming planet

Im Focus: Highly precise wiring in the Cerebral Cortex

Our brains house extremely complex neuronal circuits, whose detailed structures are still largely unknown. This is especially true for the so-called cerebral cortex of mammals, where among other things vision, thoughts or spatial orientation are being computed. Here the rules by which nerve cells are connected to each other are only partly understood. A team of scientists around Moritz Helmstaedter at the Frankfiurt Max Planck Institute for Brain Research and Helene Schmidt (Humboldt University in Berlin) have now discovered a surprisingly precise nerve cell connectivity pattern in the part of the cerebral cortex that is responsible for orienting the individual animal or human in space.

The researchers report online in Nature (Schmidt et al., 2017. Axonal synapse sorting in medial entorhinal cortex, DOI: 10.1038/nature24005) that synapses in...

Im Focus: Tiny lasers from a gallery of whispers

New technique promises tunable laser devices

Whispering gallery mode (WGM) resonators are used to make tiny micro-lasers, sensors, switches, routers and other devices. These tiny structures rely on a...

Im Focus: Ultrafast snapshots of relaxing electrons in solids

Using ultrafast flashes of laser and x-ray radiation, scientists at the Max Planck Institute of Quantum Optics (Garching, Germany) took snapshots of the briefest electron motion inside a solid material to date. The electron motion lasted only 750 billionths of the billionth of a second before it fainted, setting a new record of human capability to capture ultrafast processes inside solids!

When x-rays shine onto solid materials or large molecules, an electron is pushed away from its original place near the nucleus of the atom, leaving a hole...

Im Focus: Quantum Sensors Decipher Magnetic Ordering in a New Semiconducting Material

For the first time, physicists have successfully imaged spiral magnetic ordering in a multiferroic material. These materials are considered highly promising candidates for future data storage media. The researchers were able to prove their findings using unique quantum sensors that were developed at Basel University and that can analyze electromagnetic fields on the nanometer scale. The results – obtained by scientists from the University of Basel’s Department of Physics, the Swiss Nanoscience Institute, the University of Montpellier and several laboratories from University Paris-Saclay – were recently published in the journal Nature.

Multiferroics are materials that simultaneously react to electric and magnetic fields. These two properties are rarely found together, and their combined...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

“Lasers in Composites Symposium” in Aachen – from Science to Application

19.09.2017 | Event News

I-ESA 2018 – Call for Papers

12.09.2017 | Event News

EMBO at Basel Life, a new conference on current and emerging life science research

06.09.2017 | Event News

 
Latest News

Rainbow colors reveal cell history: Uncovering β-cell heterogeneity

22.09.2017 | Life Sciences

Penn first in world to treat patient with new radiation technology

22.09.2017 | Medical Engineering

Calculating quietness

22.09.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>