EpiRespond® – a novel DNA-methylation-based companion diagnostic biomarker tests to tailor breast cancer patients to systemic chemo- or endocrine therapy.

In personalized medicine, predictive biomarkers and accompanying laboratorytests (companion diagnostics) are tools being used to test efficacy and safety of a drug specific to a targeted patient group. In cancer therapy, major challenges are to predict whether a patient will respond to standard of care (or another alternative treatment option should be recommended).

In women, breast cancer is the most common malignancy worldwide. In the Western world every 8th woman will get breast cancer of which almost half of women will die of this disease, despite improved screening, surgery, and treatment options. In Europe alone, every year 464,000 women will be diagnosed with breast cancer. The bad news is that the incidence for breast cancer will significantly increase; according to the World Health Organization (WHO) almost 50 % more cases will be reported in 2025.

Today, the so-called personalized medicine aims at identifying patients who will benefit from a specific therapy, which patients require additional therapy or which patients do not require a therapy or an alternative therapy than standard of care. Even though a variety of targeted drugs to treat breast cancer patients with systemic adjuvant therapy are available, there is still a high medical need to individualize therapy of breast cancer patients to improve overall survival and quality of life. There is no “one fits all” approach.

The new EpiRespond®-Test will help to optimize pre- and post-surgical treatment of breast cancer patients. The benefit for patients is obvious:

  • to precisely identify those patients who will benefit of chemo- and endocrine therapy and

  • patients not suited for that kind of therapy may be offered alternative ways of treatment.

Customer value

Hospital doctors or practicing gynecologists/oncologists order the breast tumor tissue 7-gene-DNA-methylation status by means of the EpiRespond®-Test. DNA is extracted from fixed breast tumor tissue available at primary diagnosis of cancer, subjected to bisulfite treatment followed by the EpiRespond®-Test (qRT-PCR). A quantifiable read-out of the methylation status for each individual gene is generated, and based on these data it is concluded whether or not the patient would fall into a certain risk group, e.g. might benefit of a certain adjuvant chemo- +/- endocrine treatment or alternative therapy.

The EpiRespond® -Test could identify with a 90% probability whether a patient will benefit from a specific chemotherapy or not. The EpiRespond®-Test will also identify those patients presenting with an increased risk in developing metastases, despite chemotherapy and who may need alternative ways of postsurgical management.