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Regulatory News: Article   Printable Version 


Regulatory News Article
SPOT-Light Cleared for HER2 Testing

The U.S. Food and Drug Administration (FDA) has approved Invitrogen Corp’s genetic test SPOT-Light HER2 CISH for the identification of HER2-positivity among breast cancer patients.

The test measures copies of the HER2 genes from a biopsied tissue sample. Stored tissue samples can also be used for the test.

SPOT-Light HER2 CISH utilizes a chemical applied to the tissue sample that results in a color change of HER2 genes. This color change can be seen with a standard microscope, eliminating the need for FISH or other testing procedures.



© 1998-2007 OncoEd.com 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.
© 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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