EndoPredict®

by Myriad Genetics, Inc.

Breast Cancer Treatment

In breast cancer, crucial factors for the right choice of treatment are molecular markers such as hormone receptors and the growth factor receptor HER2/neu. Thus, the tumors can be divided into three subgroups important for diagnosis.

According to the current clinical guidelines, hormone receptor-negative (HR-) or HER2/neu-positive tumors are usually treated by chemotherapy, because this therapy is especially effective in the control of these two tumor subtypes. In patients with hormone receptor-positive and HER2/neu-negative breast cancer, the benefits of chemotherapy are often lower. This group includes about 65% of all breast cancer patients.

The majority of these patients would be adequately treated with anti-hormonal therapy, whose side-effects are lower, but some do benefit from additional chemotherapy. Since the classical examination methods, however, do not allow clear judgement as to which treatment is most appropriate, as a precaution the majority of these patients are treated with chemotherapy. Thus many patients are over-treated.

Detailed analyses of the growth behaviour of a tumor at the genetic level have been included recently into the accepted guidelines (e.g. AGO, St. Gallen). The tests provide valuable additional information to select the therapy most appropriate for an individual patient. The only test of this kind that can be performed onsite in the tumor centers is EndoPredict®.

EndoPredict® Testing

EndoPredict is a prognostic 2nd generation IVD gene expression test to determine the risk of distant metastases in patients with estrogen receptor positive, HER2-negative primary breast cancer.

EndoPredict® is a multi-gene test for breast cancer patients. Using a specially developed procedure, it determines whether a given patient needs chemotherapy, or whether solely anti-hormonal therapy constitutes sufficient treatment.

The test allows identification of a low-risk group that can expect a chance of more than 95% for metastasis-free survival for at least ten years under solely anti-hormonal treatment for five years. The EndoPredict® is the first mutagen test for breast cancer to provide significant additional information over all other commonly used methods.

Identifying Patients Suitable for EndoPredict®

EndoPredict® is suitable for the majority of patients with breast cancer, namely for those with a primary, hormone receptor positive, HER2/neu-negative tumor. It is irrelevant whether lymph nodes have already been affected or not.

Benefits of EndoPredict ® Testing

The vast majority of patients with hormone receptor-positive and Her2/neu-negative breast cancer have an excellent prognosis – even when the tumor has already infiltrated some lymph nodes. Among these patients EndoPredict® identifies the group which under solely anti-hormonal treatment will in more than 95% of cases not develop any distant recurrence within ten years. EndoPredict® is thus able to reliably predict even metastasis formation which occurs later than five years after diagnosis.

Managing patients assessed with EndoPredict®

Since tumor cells can be described much more accurately with the EndoPredict® test than conventional prognostic factors allow, the therapies can be better targeted. For patients with a low risk of disease progression, this means that they are sufficiently treated with anti-hormonal therapy.

Studies have shown that 60% of patients eligible for prognosis determination with EndoPredict® could have done without stressful chemotherapy thanks to their actually low-risk profile.

What is the unique advantage of the EndoPredict® test from Myriad?

EndoPredict® is the only test of its kind to combine the established clinical prognostic factors of tumor size and lymph node status with the genetic fingerprint of the tumor (EP score) into the EPclin Score. As could be demonstrated in numerous clinical trials, this combination provides valuable additional prognostic information to make an informed treatment decision.

EndoPredict ® FAQs

[accordion][accordion-item title="How do I order a test?"]Please contact us and let us know if you would like to order a test for a patient. One of our representatives will get in touch with you and advise on the workflow, and provide the necessary forms and sample collection kits. Once the samples have been collected, we will coordinate the shipment of the sample to the laboratory. Once testing is completed, the report will be sent to you.[/accordion-item][accordion-item title="Who is eligible for EndoPredict®?"]EndoPredict® can be used in patients with newly diagnosed breast cancer. The tumor must be hormone receptor-positive and Her2/neu-negative. The test is suitable when no lymph nodes are infiltrated, as well as with up to three positive lymph nodes.[/accordion-item][accordion-item title="When is EndoPredict® used?"]EndoPredict® can be used as soon as a tissue sample of the invasive tumor is available. The sample can be taken either by core needle biopsy or during surgery. The test will be used to provide additional decision support as to whether chemotherapy is necessary or not.[/accordion-item][accordion-item title="How long do you have to wait for the result?"]Currently, samples are sent to an international lab. The results for these samples can be expected within 2-3 weeks. If the test is set up at a local lab, the test result can be provided within a few days.[/accordion-item][accordion-item title="Which genes are tested?"]A total of twelve genes are measured. Here the eight disease-relevant genes BIRC5, UBE2C, DHCR7, RBBP8, IL6ST, AZGP1, MGP and STC2 are compared to three RNA normalization genes (CALM2, OAZ1 and RPL37A) and to one DNA reference gene (HBB).[/accordion-item][accordion-item title="How much tumor material is needed for testing?"]Only one section (tumor content 30%) of a tissue block is needed.[/accordion-item][/accordion]