AMSTERDAM, Netherlands, December 13 /PRNewswire/ --
- Results to be presented at San Antonio Breast Cancer Symposium
Agendia BV, world leader in the rapidly evolving field of molecular diagnostics, announced today that an independent international consortium has demonstrated the prognostic power of its MammaPrint(R) breast cancer prognosis test in patients who have 1-3 positive lymph nodes. The data show that MammaPrint(R) can accurately identify a low risk group of lymph node-positive breast cancer patients with an excellent survival, implications that will help doctors to decide the optimal treatment management.
"Lymph node status is considered to be one of the most powerful prognostic factors for operable breast cancer, with a direct relationship between the number of positive nodes and disease outcome. However, approximately 30% of lymph node-positive patients will remain free of distant metastases without adjuvant chemotherapy," said Dr Laura van 't Veer, chief research officer at Agendia, who participated in the study. "Identifying patients with lymph node-positive disease who are at low risk of recurrence might lead to changes in guidelines for adjuvant chemotherapy."
In the current study, 241 tumor samples from breast cancer patients with 1-3 positive lymph nodes at 2 hospitals were selected and analyzed by the international TRANSBIG consortium. Patients that were classified as "high risk" for recurrence using MammaPrint(R) had significantly worse 5- and 10-year survival rates than those that were identified as "low risk." The numbers indicate that MammaPrint(R) has excellent prognostic power, even in patients having 1-3 positive lymph nodes. The entire study will be presented as an oral presentation at the San Antonio Breast Cancer Symposium on Thursday, December 13 in San Antonio, TX, USA.
"This study is in excellent agreement with our 2002 publication in the New England Journal of Medicine in which we also found that MammaPrint(R) is a powerful predictor of disease outcome in lymph node positive breast cancer patients," said Prof. Dr. Rene Bernards, chief scientific officer at Agendia. "Based on these data, the inclusion criteria of the large MINDACT clinical trial using MammaPrint(R) will be enlarged to include patients with 1-3 positive nodes."
Agendia will start offering MammaPrint(R) to patients having 1-3 positive lymph nodes in Europe. These data will also be submitted to the U.S. Food and Drug Administration (FDA) for regulatory approval at a later date.
MammaPrint(R) laboratory service is the first and only 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 may 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, located in Amsterdam, The Netherlands, is a world leader in gene expression analysis-based diagnostics with three products on the market. The company focuses on the development and commercialization of diagnostic tests using tumor gene expression profiling. Agendia was the first company to receive FDA approval for its breast cancer test -- MammaPrint(R) -- that predicts the risk of breast cancer recurrence. Its second microarray product, CupPrint(R)(i), is a diagnostic test to identify the origin of a metastasis in a cancer type called "Cancer of Unknown Primary." Agendia recently also presented its new colon cancer prognosis test, ColoPrint(R), which is currently undergoing further validation. Agendia maintains close ties with several leading academic centers to develop state of the art diagnostic tests for cancer. Agendia also offers its expertise to pharma companies focusing on development of highly effective personalized drugs in the area of oncology. For more information on Agendia, visit http://www.agendia.com.
(i) CupPrint(R) is based on a license to the TUO database of AviaraDx
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