Inventors:
Dennis J. Slamon - Woodland Hills CA
William L. McGuire - San Antonio TX
Assignee:
The Regents of the University of California - Berkeley CA
International Classification:
C12Q 168, G01N 5300, G01N 3300
Abstract:
Amplification of the HER-2/neu oncogene is related to the status of neoplastic diseases, particularly breast and ovarian adenocarcinomas. The presence of multiple gene copies in tumor cells indicates that the disease is more likely to spread beyond the primary tumor site, and that the disease therefore may require more aggressive treatment than might otherwise be indicated by other diagnostic factors. In particular, the degree of gene amplification appears to provide greater prognostic utility than either the estrogen receptor or the progesterone receptor, and provides utility equal to that of the determination of lymph node status. The information provided by the gene amplification test, however, is not duplicative with the determination of lymph node status and the two tests together provide greatly improved prognostic utility.