The EndoPredict Test, made by Sividon Diagnostics and distributed by Myriad, is a genomic test that analyzes the activity of a group of genes that can affect how a cancer is likely to behave and respond to treatment.
Research suggests the EndoPredict 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.
Knowing if a woman has a high or low risk of early-stage breast cancer coming back might help women and their doctors decide if chemotherapy or other treatments to reduce risk after surgery are needed.
Right now, the EndoPredict test is approved to be used in Europe but not the United States. Sividon, the company that makes the EndoPredict test, has said that it plans to seek U.S. Food and Drug Administration approval for the test.
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 EndoPredict test?
You may be eligible for the EndoPredict test if:
- you’ve recently been diagnosed with early-stage, hormone-receptor-positive, HER2-negative breast cancer
- there is no cancer in your lymph nodes (node-negative disease), or there are up to three positive nodes
- you and your doctor are making decisions about chemotherapy
The EndoPredict test is performed on preserved tissue that was removed during the original biopsy or surgery.
Right now, the EndoPredict test is only available in Europe.
How does the EndoPredict test work?
The EndoPredict test measures the levels of 12 genes in breast cancer cells. These measurements are used to calculate an EP risk score that is then combined with the cancer tumor size and the nodal status of the cancer (how many lymph nodes tested positive for cancer). The result is the EPclin Score, which classifies the cancer as having a high risk or a low risk of the cancer metastasizing to an area of the body away from the breast.
Doctors interpret the EPclin Score as follows:
- Cancers considered at low risk for distant metastasis may be able to be treated with hormonal therapy alone, allowing these women to avoid chemotherapy.
- Cancers considered at high risk for distant metastasis should probably be treated with hormonal therapy and chemotherapy.
You and your doctor will consider the EPclin Score in combination with other factors such as the grade of the cancer, the number of hormone receptors the cancer cells have (many versus few), and your age. Together, you can make a decision about whether or not you should have chemotherapy.
Insurance coverage and financial assistance
Because the EndoPredict test is not approved by the FDA, it may not be covered by insurance in the United States. If you live outside the United States and your doctor recommends the EndoPredict test, contact your insurance company to see if the test is covered.
Other genomic tests
There are other genomics tests used to analyze breast cancer tumors. To learn more, click on the links below.
- The Breast Cancer Index test is used to predict the risk of node-negative, hormone-receptor-positive breast cancer coming back 5 to 10 years after diagnosis.
- 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 Mammostrat test is used to predict the risk of recurrence of early-stage, hormone-receptor-positive breast cancer.
- 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.