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A History of Science
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.
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. As market awareness of our products in the United States and Europe grew, 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 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. |
