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New Study Demonstrates Patients With High-Risk MammaPrint Profile Benefit From Chemotherapy
HUNTINGTON BEACH, California, and AMSTERDAM, April 29, 2010 (ots/PRNewswire) -- Today, at the 11th Annual Meeting of the American Society of Breast Surgeons, Agendia, a world leader in molecular cancer diagnostics, announced that Breast Cancer Research and Treatment has 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 takes places April 28 - May 2, 2010, at the Bellagio in Las Vegas, where you can meet the Agendia team at booth # 314.
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, MD, FACP, Chief Medical Officer of Agendia and study co-author.
The study titled, "The predictive value of the 70-gene signature for adjuvant chemotherapy in early breast cancer," can be accessed at http://www.springer.com/medicine/oncology/journal/10549.
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 analytical validation and reporting systems to ensure patient safety issues are addressed. Highly accurate, MammaPrint identifies patients with early metastasis risk - patients who are likely to develop metastases within five years following surgery. Several authoritative studies have shown that chemotherapy particularly reduces early metastasis risk. In planning treatment, the MammaPrint test results provide doctors with a clear rationale to assess the benefit of chemotherapy in addition to other clinical information and pathology tests.
All MammaPrint tests are conducted in Agendia's CAP-accredited and CLIA compliant service laboratories. Breast cancer recurrence assays currently marketed by other manufacturers have not been subject to the rigorous FDA clearance process.
Agendia is at the forefront of the personalized medicine revolution, striving to bring more effective, individualized treatments within reach of patients. Building on a cutting-edge genomics platform for tumor gene expression profiling, the company's tests help physicians more accurately tailor 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. Agendia is based in Huntington Beach, California, and in Amsterdam, The Netherlands.
ots Originaltext: Agendia B.V.
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