摘要:
The present invention describes methods and probe composition for an automated FISH assay of a blood sample containing circulating tumor cells expressing the IGF-1R gene. The assay provides genetic analysis of suspect circulating tumor cells that have been identified after immunomagnetic selection and fluorescent labeling. Using unique, repeat-free probes to the IGF-1R locus and a chromosome 15 reference probe, cell lines expressing an aberrant number of IGF-1R and Chr 15 signals were detected, including one cell line with a low level of IGF-1R amplification. The ability to directly examine the genetic profile of IGF-1R on circulating tumor cells may provide an automated means for assessing disease and patient response to therapy.
摘要:
Amplification and overexpression of theHER-2 oncogene in breast cancer is felt to be stable over the course of disease and concordant between the primary tumor and metastases. Therefore, patients with HER-2 negative primary tumors will rarely receive anti-HER-2 antibody therapy. A very sensitive blood test is used to capture circulating tumor cells (CTC's) and evaluate their HER-2 gene status by FISH evaluation. The HER-2 status of the primary tumor and corresponding CTC's is used to assess the ratio of CTC's as a reliable surrogate marker. HER-2 expression of 10 CTC's is sufficient to make a definitive diagnosis of the HER-2 gene status for the whole population of CTC's in patients with recurrent breast cancer.