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)*, is a diagnostic test to identify
the origin of a metastasis in a cancer type
|SOURCE Agendia BV|
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