309a panel of 21 genes using RT-PCR. The likelihood of distant recurrence in patients
with ER-positive breast cancer without involvement of lymph nodes is poorly
defi ned by clinical and histopathological measures. Analysis of RT-PCR profi les
obtained from tumor blocks show that recurrence score is predictive of overall sur-
vival in individual tamoxifen-treated patients with node-negative, estrogen-receptor-
positive breast cancer.
Prosigna Breast Cancer Prognostic Gene Signature Assay (NanoString) pro-
vides digital readout of expression of 50 genes implicated in the growth and spread
of cancer. The score is used to estimate the chance that cancer may recur after hor-
mone therapy.
The MammaPrint Test (Agendia) This FDA-approved 70-gene microarray assay
is used to provide important prognostic information for individuals with primary
invasive breast cancer with lymph node negative disease of either positive or nega-
tive estrogen receptor status. The microarray assay looks at what specifi c genes are
expressed in a patient’s tumor. When compared to clinical factors currently used by
physicians in the prognosis of breast cancer such as age, tumor size, lymph-node
status, tumor grade and estrogen receptor status, the MammaPrint test has shown to
provide the best single prognostic information concerning the development of dis-
tant metastases. Large-scale prospective clinical trials of the breast cancer prognosis
test have been carried out. MammaPrint test outperformed the clinicopathologic
risk assessment in predicting all endpoints and adds independent prognostic infor-
mation to clinicopathologic risk assessment for patients with early breast cancer as
well. To facilitate its use in a diagnostic setting, the 70-gene prognosis profi le was
translated into a customized MammaPrint containing a reduced set of 1,900 probes
suitable for high throughput processing. RNA of 162 patient samples from two pre-
vious studies was subjected to hybridization to this custom array to validate the
prognostic value. Classifi cation results obtained from the original analysis, when
compared to those generated using the algorithms based on the custom mini-array,
show a high correlation of prognosis prediction. Therefore, the array is an excellent
tool for predicting outcome of disease in breast cancer.
TargetPrint ®^ (Agendia) This FDA approved test enables quantitative determina-
tion of gene expression levels of the estrogen receptor, progesterone receptor and
HER2 in breast cancer biopsies. This is of paramount importance in planning
treatment of breast cancer patients after surgery and assists physicians and patients
in making informed treatment decisions. TargetPrint runs on Agendia’s High
Density Chip.
TOP2A FISH pharmDx Test (Dako) uses FISH to detect or to confi rm abnormali-
ties in the topoisomerase 2 alpha gene, which is involved in DNA replication.
Changes in this gene in breast cancer cells can be used to predict likelihood of tumor
recurrence or long-term survival of a patient. The FDA approved this test in 2008
with the remark that this is the fi rst test to be approved that targets the TOP2A gene
in cancer patients. The FDA has deemed the test suitable for premenopausal patients
or those who have other indicators of higher chances of tumor recurrence, such as
tumor size or lymph node involvement, or decreased survival. The test was studied
Personalized Management of Cancers of Various Organs