Multiparameter Gene Expression Tests
for Breast Cancer

Tests

Oncotype DX
Oncotype DX is a 21-gene expression profile that measures 16 cancer-related genes in triplicate and has 5 reference genes
Intended use
It evaluates the likelihood of breast cancer recurrence and assesses the benefit of adjuvant chemotherapy
Type of patient/tumor
Newly diagnosed patient who has Stage I or II cancer that is estrogen receptor-positive and lymph node negative and who will be treated with tamoxifen
Type of sample
Formalin-fixed, paraffin-embedded tumor tissue
Method
Quantitative RT-PCR (reverse transcriptase-polymerase chain reaction)
Results
Calculated results assign a “Recurrence Score” between 0 and 100 with less than 18 defined as low-risk of distant recurrence within 10 years, greater than 31 as high-risk, and between 18-30 as intermediate risk. Patients with a high-risk score are more likely to benefit from adjuvant chemotherapy.
Status of test
Available from one laboratory

MammaPrint
MammaPrint is a 70-gene expression profile test that measures 70 cancer-related genes in triplicate and measures reference genes (normalization genes and negative controls)
Intended use
To predict the likelihood of breast cancer recurrence within five to 10 years.
Type of patient/tumor
Newly diagnosed patients who are under 61 years of age, have Stage I or II cancer that is equal to or less than 5 centimeters (2 inches) in length and is lymph node negative
Type of sample
Fresh frozen tumor sample that has a minimum of 30% malignant cells
Method
DNA microarray
Results
Calculation of MammaPrint Index and a prognosis assignment score of Low Risk or High Risk
Status of test
Cleared by the FDA; commercially available in one location – in the Netherlands

Breast Cancer Gene Expression Ratio, 2-gene ratio, H/I or HOXB13/IL17BR
The Breast Cancer Gene Expression Ratio is a 2-gene expression test that evaluates the expression ratio H:I of the homeobox gene (HOXB13) and the interleukin-17B receptor gene (IL-17BR)
Intended use
To help predict recurrence of breast cancer
Type of patient/tumor
Newly diagnosed patient who has estrogen receptor-positive and lymph node negative breast cancer
Type of sample
Formalin-fixed, paraffin-embedded tumor tissue
Method
Quantitative RT-PCR
Results
Reported as an H:I ratio with a 5-year recurrence risk. Risk increases with increasing ratio
Status of test
Commercially available, but ASCO recommends more supporting data on clinical utility

Rotterdam Signature 76-Gene Panel
The Rotterdam Signature test is a 76-gene expression assay. Sixty genes are intended to evaluate estrogen-receptor positive samples and 16 genes to evaluate estrogen-receptor negative samples
Intended use
Predict risk of breast cancer recurrence
Type of patient/tumor
Lymph node negative breast cancer patients
Type of sample
Fresh frozen tumor sample
Method
RNA expression microarray
Results
Hazard ratio for distant recurrence
Status of test
Being researched; not commercially available