The mission of Agendia is to improve the quality of life for cancer patients, through molecular diagnostics, one patient at a time

 

Clinically Relevant Gene Expression Profiling for Cancer Patients

We are a commercial-stage molecular diagnostic company, focused on the discovery, development and commercialisation of innovative products to improve the quality of life for cancer patients by providing healthcare professionals with critical information to enable safe and effective personalised treatment. 

 

We are currently marketing our Symphony™ suite of four complementary breast cancer tests, of which two currently generate revenue, with a strong focus on the US market.  We have discovered, validated and received FDA clearance for the use of clinically useful gene expression profiles for our lead test, MammaPrint®, through a combination of our own research and research collaborations and strategic alliances with academia. 

 

The current breast cancer treatment paradigm is expensive and has significant shortcomings as a result of relatively poor assessment of recurrence risk and over-use of chemotherapy.  Our MammaPrint® test has shown a clinically validated ability to predict the risk of breast cancer recurrence in the first five years after diagnosis, which is the period in which chemotherapy produces most of its benefits to a patient. 

 

MammaPrint® thereby gives physicians a more accurate tool to separate "high" risk from "low" risk early stage breast cancer patients and better gauge the "high" risk patients’ need for chemotherapy than is currently available.


 

Agendia – A Growing Business

We were founded in 2003 as a spin-off from the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital in Amsterdam, for the purposes of pursuing commercialisation of molecular diagnostics using DNA microarray technology for cancer diagnosis and drug development.  In 2004 we launched the initial version of our MammaPrint® breast cancer recurrence test in Europe. 

 

In 2006, we subjected MammaPrint® to an international independent retrospective validation which led to the selection of MammaPrint® as the exclusive molecular diagnostic stratification tool for the MINDACT trial, featuring 6,000 patients at 109 institutions in nine European countries. 

 

In 2007, MammaPrint® became the first IVDMIA to obtain 510(k) clearance from the FDA, and after receipt of this regulatory clearance we made MammaPrint® commercially available in the United States in 2008.

 

We also began to market other elements of our Symphony™ suite of breast cancer tests, adding TargetPrint® in 2009 and also, in 2010, BluePrint™ and TheraPrint® as laboratory developed tests (LDTs).  A significant landmark in our commercial development was our inclusion in 2009 in a local coverage determination by the Medicare carrier in California which processes all of our Medicare reimbursement claims. 

 

Agendia Today

We believe we have key strengths and advantages which give us an opportunity to further develop our product.

 

A new set of genomic-based diagnostic tools for oncologists.The four products which make up our Symphony™ suite of complex molecular diagnostic breast cancer tests - TargetPrint®, MammaPrint®, BluePrint™ and TheraPrint® - provide a comprehensive decision support system that enables physicians to determine whether a given breast cancer patient is likely to benefit from hormonal therapy, chemotherapy or targeted therapies. 

 

Benefits over existing treatment approaches – for patients, physicians and payors.  We believe Symphony™ significantly improves breast cancer patient outcomes, not only clinically but also by reducing healthcare costs as a cost-effective means of guiding adjuvant chemotherapy use in patients with early stage breast cancer, and offers significant benefits over existing treatment approaches.

 

Strong scientific background and pipeline of innovative products.  Our development pipeline includes a further extension of our breast cancer tests as well as similar molecular diagnostic products for colon and lung cancer in various stages of validation, companion diagnostic products, biomarkers for pathway-targeted therapies and new clinically-relevant molecular subtype products under development or under active investigation. 

 

We believe our strategic alliances with leading academic consortia and cancer centres as well as with large international pharmaceutical companies will contribute to our ability to develop new molecular diagnostic tests in breast cancer and other cancer areas.  Tests are performed in Agendia's state-of-the-art genomics laboratories in Irvine, California or at the company’s headquarters in Amsterdam, the Netherlands.