Agendia to file for expanded FDA clearance for MammaPrint(R)
AMSTERDAM, Netherlands, Dec. 17 /PRNewswire/ -- Agendia BV, world leader in the rapidly evolving field of molecular diagnostics, announced today that its MammaPrint(R) breast cancer prognosis test was shown to be a valuable tool to assess risk of breast cancer recurrence also in postmenopausal breast cancer patients. Data recently presented at the AACR/NCI/ EORTC conference "Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications" in San Francisco showed that MammaPrint is a valuable tool to assess risk of breast cancer recurrence in older age breast cancer patients as well.
To date, MammaPrint has received two clearances from the Food and Drug Administration (FDA) for its test. The first clearance in February of this year cleared MammaPrint for safety and effectiveness under the In Vitro Diagnostic Multivariate Index Assay (IVDMIA) Guidelines for use in breast cancer prognosis. In June, 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. FDA clearance also ensures the validity of the RNA integrity chain from patient to result, which ensures that the whole test procedure is fit for daily clinical settings. With the new data, Agendia will seek additional clearance from the FDA for its MammaPrint breast cancer prognosis test to include patients over age 60.
In the underlying study, breast tumors from 100 patients with lymph node- negative, invasive breast cancer (median age 62 years, but also including elderly patients over age 75) who were diagnosed and treated at the Massachusetts General Hospital in Boston, USA between 1985 and 1997 were subjected to MammaPrint gene expression analysis. MammaPrint, having a digital readout, classified patients as being at either low or high risk for distant metastasis and the results were compared to actual outcome of disease in these patients. The results of the study confirm that MammaPrint is also a very powerful tool to identify older breast cancer patients at low risk for metastatic disease. The results of this study have been submitted for publication to one of the major clinical research journals.
"We are very pleased with this new validation study," says Bernhard Sixt, chief executive officer (CEO) of Agendia. "MammaPrint is now independently validated for both premenopausal and postmenopausal women, an important and necessary validation considering that breast cancer biology between the two groups is different. We are confident that we now have enough data to seek clearance from the FDA for use of this test in breast cancer patients of all ages."
MammaPrint(R) laboratory service is the first and only FDA cleared (February 2007) DNA microarray-based 'in vitro diagnostic multivariate index assay' (IVDMIA). MammaPrint measures the activity of 70 genes, providing information about the likelihood of tumor recurrence. The MammaPrint 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 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 called "Cancer of Unknown Primary". Agendia recently also presented its new colon cancer prognosis profile, 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.
* RNARetain(R) is a trademark of Asuragen Inc.
* CupPrint(R) is based on a license to the TUO database of AviaraDx
|SOURCE Agendia BV|
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