Agendia is committed to transforming research findings into robust diagnostic tests that are available globally through its high quality clinical laboratory. The company establishes clinically useful gene expression profiles through its own research, research collaborations and strategic alliances with academia. A unique cooperation with the Netherlands Cancer Institute (NKI) and collaborations other leading academic centers, pharmaceutical and biotech companies, enable Agendia to conduct an extensive range of clinical and research studies. Consequently, during its short existence, the company has already built a rich product pipeline.

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Microarray 8-pack, each containing up to 19,000 genetic
probes allowing for simultaneous hybridizations.

Improving patient care

Several studies are currently ongoing for the development of gene expression profiles in cancer as well as in other disease areas. Closest to commercialization are a new breast cancer profile to help doctors select the optimal therapy for their patient, and a prognostic colon cancer profile, ColoPrint.

Enhancing drug development programs

Predictive drug response profiles comprise another area of interest within Agendia’s clinical research project portfolio. By identifying the patterns of gene expression in tumors from patients that respond to a particular drug, the success rate of drug development programs can be significantly enhanced. Agendia offers this service as DiscoverPrint. Projects aimed at identifying patients that respond to several breast cancer drugs such as Tamoxifen and Trastuzumab, are ongoing.

Increasing acceptance of existing products

The success of the independent validation of MammaPrint by the TRANSBIG research consortium has justified the commencement of a large collaborative MINDACT trial. MINDACT aims to give a definitive answer as to the clinical relevance of MammaPrint, its performance compared to traditional prognostic factors and its ability to predict response to commonly prescribed adjuvant treatments.

MINDACT will enrol 6,000 breast cancer patients to determine the benefit/risk ratio of chemotherapy when the prognostic assessment based on clinical-pathological features differs from that provided by the gene signature. MammaPrint is used to classify early stage breast cancer patients as being at high or low risk of distant relapse. This assessment is compared to the “Adjuvant! Online” software risk assessment that is widely used in clinical practice today.

All 6,000 patients enrolled in the study will have their risk of recurrence assessed by traditional clinical-pathological methods and MammaPrint. Those patients classified as “high risk” by both methods will be offered adjuvant chemotherapy. Those patients classified as “low risk” by both methods will not be offered adjuvant chemotherapy, although they will be offered endocrine therapy if their tumors are endocrine responsive. Those patients for whom the two risk assessments are discordant will be randomized to receive treatment plans based on either clinical criteria (using Adjuvant! Online) or genomic prognosis (using MammaPrint).

Study design:

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Impact

It is expected that 10% to 20% of women who would normally receive adjuvant chemotherapy based on their clinical-pathological factors will be spared the inconvenience and morbidity of this therapy, without having any negative impact on their survival. The primary objective of the trial is to confirm that the number of patients that can be spared adjuvant chemotherapy is significantly increased when the decision is based on MammaPrint rather than on the clinical-pathological criteria, while the critical group of patients who have a high risk of recurrence according to the clinical-pathological criteria but a low risk according to MammaPrint is not under-treated. This will have immense benefits for women and will markedly improve our ability to predict which patients are likely to experience a distant relapse and therefore require additional systemic therapy.

Given the immense therapeutic and emotional repercussions for women, it is essential to determine, in an unbiased way, the true value of gene signatures in clinical practice today. The evaluation of the clinical application of MammaPrint to individualize management, to spare treatment without compromising long term outcome and hence diminish the public health burden is of utmost priority to women and governments.

Coordination

MINDACT is coordinated by the European Organisation for Research and Treatment of Cancer (EORTC) and run under the Breast International Group (BIG) and TRANSBIG network.

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Collaborators welcome

Agendia is continuously seeking collaborations with talented, experienced physicians or organizations to develop products that target important and unmet clinical needs. We welcome contact from anyone who would like to collaborate with us in the development of new prognostic and predictive signatures.

Please contact: Bastiaan van der Baan This e-mail address is being protected from spam bots, you need JavaScript enabled to view it