Abstract: The problem of inadequate and cost ineffective broad-range prognostic factors for breast cancer is solved by providing a method for constructing a cloning vector for preparing a multi-gene probe for a single-step determination of disease outcome. The 5-genes chosen (HER2, Topo II&agr;, NM23-H1, CK19 and MMP9) are known to show altered expression in different breast tumors. The multi-gene probe is labeled and used to screen a tumor specimen. Since five prognostic markers are prepared and used simultaneously, a wider variety of breast cancers may be covered and disease outcome prediction may be improved in a wider population at a substantially reduced cost.

Abstract: The problem of inadequate broad-range prognostic factors for breast cancer is solved by providing a multi-gene probe for a single-step determination of disease outcome. The 5-genes chosen (HER2, Topo II&agr;, NM23-H1, CK19 and MMP9) are known to show altered expression in different breast tumors. The altered expression of any one of them has a similar prognostic significance, with respect to disease-free survival or overall survival. The multi-gene probe is labeled and used to screen a tumor specimen. The signal generated after the assay provides information that has prognostic significance. Since five prognostic markers are simultaneously assessed, a wider variety of breast cancers are covered and disease outcome prediction is improved in a wider population.