National Comprehensive Cancer Network, Inc.

Description

NOTE: All of the patients in the HERCEPTIN clinical trials were selected using an investigational immunohistochemical assay (CTA). None of the patients in those trials were selected using the PathVysion assay. The PathVysion assay was compared to the CTA on a subset of clinical trial samples and found to provide acceptably concordant results. The actual correlation of the PathVysion assay to HERCEPTIN clinical outcome in prospective clinical trials has not been established.

In what circumstances might Abbott collect and use personal information? Abbott will use the personal information you provide through Abbott web sites to respond to your questions and to provide you with efficient customer service. After you have entered personal information into a form or data field on an Abbott web site, Abbott may use certain identifying technologies to allow that web site to “remember” your personal preferences, such as sections of that web site that you visit frequently and, if you choose, your user ID.

1.The PathVysion Kit has been optimized only for identifying and quantifying chromosome 17 and the HER-2/neu gene in interphase nuclei from formalin-fixed, paraffin-embedded human breast tissue specimens. Other types of specimens or fixatives should not be used. 2. The performance of the PathVysion Kit was validated using the procedures provided in the package insert only. Modifications to these procedures may alter the performance of the assay. 3.

Does Abbott share personal information with third parties? As a general rule, Abbott does not share your personal information with third parties, unless it is necessary to conduct a joint program or to carry out a program or activity through a contractor. Where required by law, Abbott will not disclose your personal information to third parties for those third parties’ marketing purposes, unless you have been provided with an opportunity to opt into or opt out of this disclosure.

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