At the 11th annual meeting of the American Society of Breast Surgeons (ASBS), a molecular cancer diagnostics company, Agendia BV (Huntington Beach, CA, USA, and Amsterdam, The Netherlands), announced that the April 2010 issue of the journal Breast Cancer Research and Treatment published an important study demonstrating the benefit of adjuvant chemotherapy for patients with a high-risk of breast cancer recurrence according to the MammaPrint test. The ASBS meeting took place April 28 - May 2, 2010, in Las Vegas, NV, USA.
The study evaluated 541 patients who were classified as either high-risk or low-risk for breast cancer recurrence using the 70-gene MammaPrint signature. For patients classified as high-risk, the addition of chemotherapy to hormone treatment showed significant survival benefit and meaningful clinical benefit. This benefit was not significant in low-risk patients, who were at such reduced risk for recurrence and cancer-related death, that adding chemotherapy did not appear to be clinically meaningful.
"It is important to provide patients with individualized treatment regimens. These findings help further this aim and confirm MammaPrint's predictive capabilities in determining which patients are likely to benefit from chemotherapy,” commented Richard Bender, M.D., FACP, chief medical officer of Agendia and study coauthor.
MammaPrint is the first and only breast-cancer recurrence test cleared by the U.S. Food and Drug Administration (FDA). FDA clearance under the in vitro diagnostic multivariate index assay (IVDMIA) guidelines requires clinical and analytic validation and reporting systems to ensure patient safety issues are addressed. In planning treatment, the MammaPrint test results provide doctors with a clear rationale to evaluate the benefit of chemotherapy in addition to other clinical information and pathology tests.
All MammaPrint tests are conducted in Agendia's College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-compliant service laboratories. Breast cancer recurrence assays currently marketed by other manufacturers have not been subject to the rigorous FDA clearance process.
Agendia Building on a cutting-edge genomics platform for tumor gene expression profiling, Agendia's tests help physicians more accurately customize cancer treatments. Agendia markets four products, with several new genomic tests under development. In addition, Agendia collaborates with pharmaceutical companies to develop highly effective personalized drugs in the area of oncology.
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