Tested and approved

MammaPrint tested and approved

• Agendia BV has been ISO 13485:2003 certified since July 27nd, 2012.
• MammaPrint has acquired CE marking.
• In February 2007, MammaPrint was cleared by the American Food and Drug Administration (FDA).
• Time Magazine proclaimed MammaPrint to be one of the best inventions of 2007 in the area of healthcare.
• In 2008 Agendia BV received the 2008 Innovation Award for MammaPrint.
• MammaPrint was developed at the Nederlands Kanker Instituut (Netherlands Cancer Institute) and Antoni van Leeuwenhoek Hospital.

The research team

Prof. Dr. Rene Bernards and Dr. Laura van ‘t Veer developed the diagnostic method for the genomic profiling of tumours. Their company, Agendia, performs tests on tumour tissue. They focus in particular on measuring the genomic activity in this tumour tissue.Working closely with the Nederlands Kanker Instituut (Netherlands Cancer Institute), Agendia carries out research in its own clinical laboratory and is constantly developing new and better tests based on DNA microarray technology. The two ‘inventors’ of MammaPrint received the prestigious European Society of Medical Oncology (ESMO) Lifetime Achievement Award for this work.

Prof. Dr. Rene Bernard

Chief Scientific Officer and co-founder of Agendia René Bernards has a 30-year track record in oncology research with more than 150 papers published in peer-reviewed scientific journals. He has initiated and developed numerous fruitful collaborations with the pharmaceutical industry. As Agendia’s Chief Scientific Researcher, René Bernards’ responsibility is to explore and implement new technologies and find appropriate partners to collaborate with. He is head of the division of Molecular Carcinogenesis at the Netherlands Cancer Institute (NKI), which he joined in 1992. Prior to that he carried out an assistant professorship at Harvard University for six years. René Bernards is a part-time professor of Molecular Carcinogenesis at Utrecht University, The Netherlands.

Dr. Laura van’t Veer

Chief Research Officer and co-founder of Agendia Dr. Laura van ‘t Veer has a 20-year track record in molecular oncology research. She has had more than 120 papers published in peer-reviewed scientific journals. Within Agendia, Laura van ‘t Veer developed the MammaPrint product. Laura van ‘t Veer was head of the DNA diagnostic laboratory and the Family Cancer Clinic at the NKI (Netherlands Cancer Institute) for over 10 years. Currently she is Director of Applied Genomics of the Cancer Center of the University of California, San Francisco, USA. Within Agendia, she is also responsible for clinical trials and the development of new genetic profiles, particularly in the context of prediction of therapy response.

Agendia

Agendia was founded in 2003 to improve the quality of life of cancer patients by means of tailor made genome technology. Agendia develops certified tests such as MammaPrint, and their aim is for this kind of test to soon be accessible to all patients who could benefit from it. Agendia’s tests assist physicians and researchers to establish a more precise diagnosis, gain a better insight into tumour development and devise a tailor made treatment plan for each individual patient. Agendia’s other products besides MammaPrint are the DiscoverPrint and the BluePrint.

How research began

Why do some cancer patients never experience metastases as opposed to other patients who do, despite the fact that they have a virtually identical tumour at the same stage? This was a mystery which oncologists all over the world wanted to solve. René Bernards and Laura van ’t Veer began to study in depth the genetic traits of breast cancer tumours. They studied the genetic traits of large quantities of stored tumour tissue and compared their findings to patients’ progress. For example, had they been cured or had metastasis occurred? The research team discovered 70 genes which appeared to play a role in the breast cancer tumour.

 

On the basis of these genes a physician would be able to determine whether a patient has a ‘high’ or ‘low’ risk of future metastasis. The outline for the MammaPrint test had been born. Years of additional research and development were required to fine tune the test, before MammaPrint could become available to everybody. This time has now come.

More about the research

MammaPrint was developed on lymph node negative (N0), ER negative and positive patients under 55 years of age. These patients had not received supplementary chemotherapy. In the initial study the researchers discovered a 70-gene signature. This signature revealed that 29 out of 34 patients who experienced metastases within five years of the diagnosis, were in fact high risk (85% sensitivity). On the other hand, the 70-gene signature of 36 out of 44 patients who did not experience any metastases within five years revealed that they were in fact ‘low risk’ (82% specificity).

 

The test was fine tuned and even in subsequent research on older breast cancer patients the 70-gene signature turned out to be an accurate risk indicator.

Genome Investigations Pty Ltd

This new Australian company commenced activity in 2013 with the aim of bringing MammaPrint and BluePrint technology to Australian women. Based in New South Wales, Genome Investigation Pty Ltd is committed to the rapid transportation of breast cancer tissue of affected women from Australian pathology laboratories to the Agendia Laboratory in California, USA, to ensure a quick turn around reporting time is made possible (usually under 2 weeks).