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Regulatory News: Article   Printable Version 


Regulatory News Article
GeneSearch™ BLN Approved for Detection of Breast Cancer Spread to Lymph Nodes

The United States Food and Drug Administration (FDA) recently approved Veridex LLC’s  (a Johnson and Johnson company) GeneSearch™ BLN Assay to detect whether breast cancer cells have spread to axillary lymph nodes. GeneSearch BLN Assay is the first molecular-based lab test to detect this stage of cancer.

The GeneSearch BLN Assay is a test that can detect molecules that are abundant in normal breast tissue but typically not present in a normal lymph node.

The GeneSearch BLN uses real-time reverse transcriptase-polymerase chain reaction (RT-PCR) to detect ammoglobin (MG) and cytokeratin 19 (CK 19) in lymph nodes.

 

 

 



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These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.
© 1998-2007 OncoEd, Inc  All Rights Reserved.

These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.




   




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