The Breast Cancer Index test, made by bioTheranostics, analyzes the activity of seven genes to help predict the risk of node-negative, hormone-receptor-positive breast cancer coming back 5 to 10 years after diagnosis. The test can help women and their doctors decide if extending hormonal therapy 5 more years (for a total of 10 years of hormonal therapy) would be beneficial.
The Breast Cancer Index reports two scores: how likely the cancer is to recur 5 to 10 years after diagnosis and how likely a woman is to benefit from taking hormonal therapy for a total of 10 years.
Research suggests the Breast Cancer Index test may eventually be widely used to help make treatment decisions based on the cancer's risk of coming back in a part of the body away from the breast (distant metastasis) within 10 years after diagnosis.
Right now, the Breast Cancer Index test is not approved by the U.S. Food and Drug Administration.
What are genomic tests?
Genomic tests analyze a sample of a cancer tumor to see how active certain genes are. The activity level of these genes affects the behavior of the cancer, including how likely it is to grow and spread. Genomic tests are used to help make decisions about whether more treatments after surgery would be beneficial.
While their names sound similar, genomic testing and genetic testing are very different.
Genetic testing is done on a sample of your blood, saliva, or other tissue and can tell if you have an abnormal change (also called a mutation) in a gene that is linked to a higher risk of breast cancer. See the Genetic Testing pages for more information.
Who’s eligible for the Breast Cancer Index test?
You may be eligible for the Breast Cancer Index test if:
- you were diagnosed with early-stage (stage I-III) breast cancer
- the cancer was hormone-receptor-positive and HER2-negative
- there was no cancer in your lymph nodes (lymph node-negative disease)
- you’ve been taking hormonal therapy for 4 to 5 years and want to know if taking hormonal therapy for more time will be beneficial
Research has shown that extending hormonal therapy for 5 more years — for a total of 10 years of hormonal therapy — can offer benefits for some women diagnosed with early-stage, hormone-receptor-positive, HER2-negative disease.
The Breast Cancer Index test is performed on preserved tissue that was removed during the original biopsy or surgery.
Because many women have troubling side effects, including hot flashes and joint pain, from hormonal therapy, they want to know if extending the time they take hormonal therapy is worth tolerating the side effects.
How does the Breast Cancer Index test work?
The Breast Cancer Index genomic test analyzes the activity of seven genes that can influence how likely the cancer is to come back 5 to 10 years after diagnosis, as well as how likely a woman is to benefit from 5 additional years of hormonal therapy.
The Breast Cancer Index test results have two scores:
- The BCI Prognostic score estimates how likely the cancer is to come back 5 to 10 years after diagnosis (late recurrence). Scores range from 0 to 10. Cancers with scores of 0 to 5 are classified as having low risk of late recurrence. Cancers with scores of 5.1 to 10 are classified as having a high risk of late recurrence.
- The BCI Predictive score estimates how likely a woman is to benefit from taking hormonal therapy for 5 more years for a total of 10 years. The results are reported as either low likelihood of benefit or high likelihood of benefit.
Insurance coverage and financial assistance
The Medicare program and several other major insurance companies have agreed to cover the Breast Cancer Index test.
bioTheranostics, the company that makes the Breast Cancer Index test, has a Patient Advocate Team to help you with verifying insurance coverage and obtaining reimbursement. The company also has a patient assistance program that helps pay for testing. To contact the Patient Advocate Team, call 1-844-319-8111, Monday through Friday, 7 a.m.-4 p.m. Pacific Time. The email address is firstname.lastname@example.org.
Other genomic tests
There are other genomics tests used to analyze breast cancer tumors. To learn more, click on the links below.
- The EndoPredict test is used to predict the risk of distant recurrence of early-stage, hormone-receptor-positive, HER2-negative breast cancer that is either node-negative or has up to three positive lymph nodes.
- The MammaPrint test is used to predict the risk of recurrence within 10 years after diagnosis of stage I or stage II breast cancer that is hormone-receptor-positive or hormone-receptor-negative.
- The Oncotype DX test is used to predict the risk of recurrence of early-stage, hormone-receptor-positive breast cancer, as well as how likely it is that a woman diagnosed with this type of cancer will benefit from chemotherapy after surgery. The Oncotype DX DCIS test is used to predict the risk of recurrence of DCIS and/or the risk of a new invasive cancer developing in the same breast, as well as how likely it is that a woman diagnosed with DCIS will benefit from radiation after surgery.
- The Prosigna Breast Cancer Prognostic Gene Signature Assay (formerly called the PAM50 test) is used to predict the risk of distant recurrence for postmenopausal women within 10 years of diagnosis of early-stage, hormone-receptor-positive disease with up to three positive lymph nodes after 5 years of hormonal therapy.