FDA approves new breast cancer lab test

Jul 17, 2007

The U.S. Food and Drug Administration has approved the first molecular-based laboratory test for detecting whether breast cancer has metastasized.

The GeneSearch BLN Assay test approved Monday detects molecules that are abundant in breast tissue but are scarce in a normal lymph node.

The FDA said the presence or absence of breast cancer cells in underarm lymph nodes is a strong predictor of whether the cancer has spread and is used to help decide appropriate therapy for women with metastatic breast cancer.

"The GeneSearch BLN Assay offers a new approach to sentinel node testing," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "Results of this rapid test are available while patients are on the operating table, providing a way for some women to avoid a second operation."

The GeneSearch BLN Assay is manufactured by Veridex, a Johnson & Johnson subsidiary located in Warren, N.J.

Copyright 2007 by United Press International

Explore further: Experts call for higher exam pass marks to close performance gap between international and UK medical graduates

add to favorites email to friend print save as pdf

Related Stories

How protein suicide assure healthy cell structures

Oct 31, 2013

Centrioles are tiny structures in the cell that play an important role in cell division and in the assembly of cilia and flagella. Changes in the number of centrioles are involved in diseases, such as cancer ...

Activating ALC1: With a little help from friends

Nov 29, 2012

Chromatin remodeling—the packaging and unpackaging of genomic DNA and its associated proteins—regulates a host of fundamental cellular processes including gene transcription, DNA repair, programmed cell ...

Recommended for you

What are the chances that your dad isn't your dad?

Apr 16, 2014

How confident are you that the man you call dad is really your biological father? If you believe some of the most commonly-quoted figures, you could be forgiven for not being very confident at all. But how ...

New technology that is revealing the science of chewing

Apr 15, 2014

CSIRO's 3D mastication modelling, demonstrated for the first time in Melbourne today, is starting to provide researchers with new understanding of how to reduce salt, sugar and fat in food products, as well ...

After skin cancer, removable model replaces real ear

Apr 11, 2014

(HealthDay)—During his 10-year struggle with basal cell carcinoma, Henry Fiorentini emerged minus his right ear, and minus the hearing that goes with it. The good news: Today, the 56-year-old IT programmer ...

User comments : 0

More news stories

Vietnam battles fatal measles outbreak

Vietnam is scrambling to contain a deadly outbreak of measles that has killed more than 100 people, mostly young children, and infected thousands more this year, the government said Friday.