FDA approves new breast cancer lab test

July 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: Breakthrough finds molecules that block previously 'undruggable' protein tied to cancer

Related Stories

How protein suicide assure healthy cell structures

October 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 or infertility. ...

Recommended for you

Machine Translates Thoughts into Speech in Real Time

December 21, 2009

(PhysOrg.com) -- By implanting an electrode into the brain of a person with locked-in syndrome, scientists have demonstrated how to wirelessly transmit neural signals to a speech synthesizer. The "thought-to-speech" process ...

Quantum Theory May Explain Wishful Thinking

April 14, 2009

(PhysOrg.com) -- Humans don’t always make the most rational decisions. As studies have shown, even when logic and reasoning point in one direction, sometimes we chose the opposite route, motivated by personal bias or simply ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.