HUNTINGTON BEACH, Calif., and AMSTERDAM, Netherlands
Agendia, a world leader in molecular cancer diagnostics, today announced that its signature breast cancer tumor recurrence test, MammaPrint(R), has been included in the updated 2008 guidelines of The Dutch Institute for Healthcare Improvement CBO. The CBO guidelines, which cover all areas of healthcare and have an important role to play in the improvement of the quality of patient treatment and care, were drafted in collaboration with the Dutch Association of Comprehensive Cancer Centers (ACCC) and the Dutch National Breast Cancer Consultation Group (NABON).
The inclusion of MammaPrint in CBO’s updated clinical practice guidelines represents a significant step forward for the role of molecular diagnostics in breast cancer treatment planning. Specifically, the new guidelines acknowledge the prognostic power of MammaPrint in general and highlight its ability to identify subgroups of untreated node negative patients as having a good or poor prognosis. The test also allows physicians and patients to determine with which therapy, if any, to address each individual patient’s risk profile, ultimately providing a significant benefit of more personalized medicine. The Dutch guideline committee also encouraged physicians to enter patients into the MINDACT trial to allow establishing additional knowledge.
“We are delighted that MammaPrint has been included in the CBO guidelines,”
said Bernhard Sixt, Ph.D., president and chief executive officer of Agendia.
“With a very high accuracy, MammaPrint identifies patients who have a risk of developing metastases within five to seven years after surgery. Therefore, the test is a very powerful tool that allows physicians to assess the rationale of adjuvant chemotherapy, which has been shown to be effective in reducing these early events in a meta-analysis of studies that included 30,000 patients.”
The Dutch Institute for Healthcare Improvement CBO was founded in 1979 by the Dutch Association of Medical Specialists and Dutch Association of Chief Medical Officers, as an independent, not-for-profit foundation devoted to improving the quality of patient care in The Netherlands. The guidelines are available online at www.cbo.nl and are published in the September/October issue of the Journal of the Dutch Association of Medical Oncology.
MammaPrint(R) laboratory service is the first FDA cleared (February 2007) DNA microarray-based ‘in vitro diagnostic multivariate index assay’ (IVDMIA). MammaPrint(R) measures the activity of 70 genes, providing information about the likelihood of tumor recurrence. The MammaPrint(R) test measures the level of expression of each of these genes in a sample of a woman’s surgically-removed breast cancer tumor and then uses a specific formula or algorithm to produce a score that determines whether the patient is deemed low risk or high risk for spread of the cancer to another site. The result serves to help a doctor in planning treatment and appropriate follow-up for a patient when used with other clinical information and laboratory tests. All MammaPrint(R) tests are conducted in Agendia’s CLIA-certified central service laboratory.
Agendia is a world leader in molecular cancer diagnostics. The company markets four products based on its breakthrough platform for tumor gene expression profiling, and has several new diagnostic tests under development. Agendia was the first company to receive FDA clearance for a breast cancer test, MammaPrint(R) that predicts the risk of breast cancer recurrence. In addition, the company collaborates with pharma companies to develop highly effective personalized drugs in the area of oncology. Agendia is based in Huntington Beach, California, and in Amsterdam, The Netherlands. For more information on Agendia, please visit www.agendia.com.