Agendia NV, a Dutch SME founded in 2003 as spin-off from the Netherlands Cancer Institute, is a commercial-stage molecular diagnostic company.
Agendia focusses on the discovery, development and commercialization of innovative products to improve the quality of life for cancer patients by providing healthcare professionals with critical information to enable safe and effective personalized treatment.
Breast cancer treatment decisions made by physicians have traditionally relied on clinicalpathological factors such as hormone receptor status, age, tumor size, tumor grade and lymph node involvement. Based on these criteria clinical guidelines recommend adjuvant therapy for all patients with early invasive breast cancer. However, this 'one size fits all approach' leads to a proportion of patients being over- or under-treated as the risk of recurrence is difficult to determine.
The advancements in molecular diagnostics are starting to improve the prognosis and treatment of breast- and other cancers, and specifically gene expression assays aid in designing a personalized treatment plan.
One of the products Agendia is developing is MammaPrint, an assay that identifies the risk of recurrence of breast cancer by looking at the patients’ specific tumor characteristics. The test measures the expression profile of 70 genes that play a role in metastasis of the tumor.
MammaPrint can be used for all early stage breast cancer patients and stratifies patients in two distinct groups, “Low Risk” and “High Risk” of cancer recurrence within 10 years. By providing this risk classification, MammaPrint aids in identifying which breast cancer patients will gain the most benefit of adjuvant chemotherapy.
The objective of this project is to achieve the final convincing evidence for the clinical utility of MammaPrint and to reach worldwide full-scale adoption of the assay.
To accomplish this goal there are three major focus points:
1. Inclusion of MammaPrint in the influential clinical guidelines
2. Adoption of MammaPrint in reimbursement schemes
3. Acceptance of MammaPrint by clinicians
These objectives have been translated into four clinical trials, one prospective study and three retrospective studies, each of which specifically has been selected to accomplish one or more of the above objectives.
The use of molecular diagnostic tests to stratify breast cancer patients by risk of recurrence has the potential to eliminate the utilization of unnecessary or insufficient chemotherapy.
As is generally known, chemotherapy often cause physical and psychological problems that affect the patient’s quality of life. If, by using MammaPrint, overtreatment can be decreased, the quality of life of breast cancer patients will be increased significantly. Moreover, avoidance of overtreatment also will significantly reduce healthcare costs (i.e. less use of medication and less adverse effects to be treated).
