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 New study: How does Europe become a leading player for software and IT services?
03.04.2017 | Fraunhofer-Institut für System- und Innovationsforschung (ISI)

nachricht Reusable carbon nanotubes could be the water filter of the future, says RIT study
30.03.2017 | Rochester Institute of Technology

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: Can the immune system be boosted against Staphylococcus aureus by delivery of messenger RNA?

Staphylococcus aureus is a feared pathogen (MRSA, multi-resistant S. aureus) due to frequent resistances against many antibiotics, especially in hospital infections. Researchers at the Paul-Ehrlich-Institut have identified immunological processes that prevent a successful immune response directed against the pathogenic agent. The delivery of bacterial proteins with RNA adjuvant or messenger RNA (mRNA) into immune cells allows the re-direction of the immune response towards an active defense against S. aureus. This could be of significant importance for the development of an effective vaccine. PLOS Pathogens has published these research results online on 25 May 2017.

Staphylococcus aureus (S. aureus) is a bacterium that colonizes by far more than half of the skin and the mucosa of adults, usually without causing infections....

Im Focus: A quantum walk of photons

Physicists from the University of Würzburg are capable of generating identical looking single light particles at the push of a button. Two new studies now demonstrate the potential this method holds.

The quantum computer has fuelled the imagination of scientists for decades: It is based on fundamentally different phenomena than a conventional computer....

Im Focus: Turmoil in sluggish electrons’ existence

An international team of physicists has monitored the scattering behaviour of electrons in a non-conducting material in real-time. Their insights could be beneficial for radiotherapy.

We can refer to electrons in non-conducting materials as ‘sluggish’. Typically, they remain fixed in a location, deep inside an atomic composite. It is hence...

Im Focus: Wafer-thin Magnetic Materials Developed for Future Quantum Technologies

Two-dimensional magnetic structures are regarded as a promising material for new types of data storage, since the magnetic properties of individual molecular building blocks can be investigated and modified. For the first time, researchers have now produced a wafer-thin ferrimagnet, in which molecules with different magnetic centers arrange themselves on a gold surface to form a checkerboard pattern. Scientists at the Swiss Nanoscience Institute at the University of Basel and the Paul Scherrer Institute published their findings in the journal Nature Communications.

Ferrimagnets are composed of two centers which are magnetized at different strengths and point in opposing directions. Two-dimensional, quasi-flat ferrimagnets...

Im Focus: World's thinnest hologram paves path to new 3-D world

Nano-hologram paves way for integration of 3-D holography into everyday electronics

An Australian-Chinese research team has created the world's thinnest hologram, paving the way towards the integration of 3D holography into everyday...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Marine Conservation: IASS Contributes to UN Ocean Conference in New York on 5-9 June

24.05.2017 | Event News

AWK Aachen Machine Tool Colloquium 2017: Internet of Production for Agile Enterprises

23.05.2017 | Event News

Dortmund MST Conference presents Individualized Healthcare Solutions with micro and nanotechnology

22.05.2017 | Event News

 
Latest News

How herpesviruses win the footrace against the immune system

26.05.2017 | Life Sciences

Water forms 'spine of hydration' around DNA, group finds

26.05.2017 | Life Sciences

First Juno science results supported by University of Leicester's Jupiter 'forecast'

26.05.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>