Healthcare Industry News: genomic test
News Release - February 18, 2009
Agendia Publishes Direct Evidence That MammaPrint Predicts Benefit of Chemotherapy in Breast CancerFindings Published in Peer-Reviewed Journal, Breast Cancer Research and Treatment
HUNTINGTON BEACH, California, and AMSTERDAM, February 18 -- (Healthcare Sales & Marketing Network) -- Agendia, a world leader in molecular cancer diagnostics, today announced that a study demonstrating the direct predictive ability of its breast cancer recurrence test, MammaPrint®, has been published in Breast Cancer Research and Treatment. Additionally, the study authors have been invited to present the data at the American Association for Cancer Research's 2009 Annual Meeting in Denver, Colorado.
"Our multi-study pool of patient data is maturing quickly and this is the first of a number of forthcoming publications showing MammaPrint's direct predictive ability for neoadjuvant and adjuvant chemotherapy regimens," commented Dr. Bernhard Sixt, Ph.D., President and Chief Executive Officer. "These findings considerably add to MammaPrint's well-established indirect predictive evidence for any chemotherapy, since MammaPrint is highly prognostic for early metastasis risk. Only early metastasis risk can be reduced by chemotherapy as shown by the Early Breast Cancer Trialists' Collaborative Group in their most recent 5-year update*. These new findings will further support our ongoing discussions with payers and guideline committees."
The study directly addresses a major concern expressed in an excellent review** on the impact of tumor gene expression profiling outcomes in patients with breast cancer recently published by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. In its recommendations EGAPP is particularly concerned by the lack of direct evidence linking tumor gene expression profiling to improved outcomes. The current study provides this evidence for MammaPrint and persuasively establishes this link.
About the study
The study was performed in collaboration with the Netherlands Cancer Institute and analyzed the association between the pathological complete response (pCR) rate and the results of the MammaPrint® test. The achievement of pCR is a valuable indicator for long-term response in this clinical setting. A consecutive series of 167 patients who received neoadjuvant chemotherapy for stage II or III breast cancer was analyzed to assess MammaPrint's predictive power. 20 percent of the 144 patients in the high risk group achieved a pCR, whereas none of the patients in the low risk group achieved a pCR. After a median follow-up of 25 months, 17 relapses were seen in the high risk group and none in the low risk group. These findings demonstrate that tumors with a high risk MammaPrint® signature are sensitive to chemotherapy.
MammaPrint is the first 'in vitro diagnostic multivariate index assay' (IVDMIA) cleared by the U.S. Food and Drug Administration (FDA). FDA clearance requires clinical and analytical validation and reporting systems to ensure patient safety issues are addressed. Highly accurate, MammaPrint identifies patients with early metastasis risk - those 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 result provides a doctor 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 CLIA-certified service laboratory. 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 aim to help physicians more accurately tailor cancer treatments. The company 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. For more information please visit http://www.agendia.com.
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