AMSTERDAM, The Netherlands, Dec. 12 /PRNewswire/ -- Agendia makes its breast cancer prognosis test, MammaPrint(R), available to U.S. patients after receiving two clearances from the Food and Drug Administration (FDA) for its test. The first clearance in February of this year cleared MammaPrint(R) as an In Vitro Diagnostic Multivariate Index Assay (IVDMIA) for use in breast cancer prognosis. In June of this year, Agendia received a second clearance for the test in conjunction with RNARetain(R)*, an RNA stabilizing solution allowing shipping of tumor biopsies at ambient temperature, greatly facilitating the logistical process of sample handling.
"We are very pleased to make MammaPrint widely available to U.S. patients and their physicians," said Bernhard Sixt, chief executive officer and co-founder of Agendia. "We believe it will play an important role in patients' course of treatment, and Agendia is seriously committed to educating the marketplace about the superior aspects of this diagnostic tool, which has broader indications and clearer results over other available options."
Dr. Neal S. Goldstein, MD, Director, Molecular Oncology and Advanced Diagnostics Laboratory of William Beaumont Hospital in Royal Oaks, Michigan says, "I prefer MammaPrint(R) because it is applicable for both ER positive and ER negative breast cancers as there is no standard determining the ER status. In addition, MammaPrint(R) encompasses many genes and, as cancers are complex, the clinical utility of assays using smaller numbers of genes is dubious in my opinion."
Agendia's Chief Operating Officer Dr. Jan Groen says, "The University of California at San Francisco (UCSF) Medical Center at Mount Zion and the Dan L. Duncan Cancer Center at Baylor College of Medicine in Houston, Texas were the first two reference centers in the U.S. to offer the test to patients. We expect to announce additional centers by the end of the year."
MammaPrint(R) is a DNA micro array-based in vitro diagnostic laboratory service that 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 a distant site (metastasis). The result may help a doctor in planning appropriate follow-up for a patient when used with other clinical and pathological information.
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 commercialize a prognostic test -- MammaPrint(R) -- that predicts the risk of breast cancer recurrence. 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.
* RNARetain(R) is a trademark of Asuragen Inc.
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