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Published on 6/6/2006 in the Prospect News Biotech Daily.

Bayer: Blood test helps predict clinical outcome to trastuzumab-based therapy

By Elaine Rigoli

Tampa, Fla., June 6 - Bayer HealthCare said findings from a study using Bayer Diagnostics' Serum HER-2/neu test demonstrated that metastatic breast cancer patients whose serum HER-2/neu levels decreased by less than 20% experienced decreased benefit from trastuzumab-based therapy.

The Serum HER-2/neu test is the only blood test cleared by the Food and Drug Administration for ongoing monitoring of changes in serum levels of HER-2/neu, a protein that helps control cell growth.

The findings allowed the 307 metastatic breast cancer patients who had the Serum HER-2/neu test before and after trastuzumab-based treatment to be divided into those with a greater than 20% decrease in serum HER-2/neu levels and those with a less than 20% decrease.

The patients whose serum HER-2/neu levels decreased by less than 20% had a lower response rate; shorter duration of response; shorter time to progression; and decreased overall survival rate, according to a news release.

Bayer HealthCare AG, a subsidiary of Bayer AG, is a global health care and medical products company.


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