Healthcare Industry News: genomic test
News Release - December 12, 2008
Agendia's MammaPrint(R) Predicts Response to Neoadjuvant Chemotherapy in Breast CancerHUNTINGTON BEACH, California and AMSTERDAM, December 12 -- (Healthcare Sales & Marketing Network) -- Agendia, a world leader in molecular cancer diagnostics, today announced MammaPrint®'s ability to predict response to neoadjuvant chemotherapy in breast cancer.
Dr. Laura van 't Veer, from the Netherlands Cancer Institute, presented the data at the 2008 San Antonio Breast Cancer Symposium (SABCS) during the session Molecular profiling for guiding therapeutic decisions. The study analyzed the association between the pathological complete response (pCR) rate and the results of the MammaPrint test.
"Physicians are increasingly supportive of MammaPrint in clinical practice because they believe it provides them with invaluable information for patient treatment planning. MammaPrint's ability to accurately determine high risk patient responsiveness to chemotherapy both confirm and speak to the confidence physicians express in this state-of-the-art genomic breast cancer test," commented Dr. Richard Bender, Chief Medical Officer of Agendia and a life-long practicing oncologist who made a career at the NCI, Kaiser Permanente and Quest Diagnostics.
Findings in the neoadjuvant setting support MammaPrint's predictive power for chemotherapy response, in addition to its previously demonstrated prognostic value for early stage disease. 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 were analyzed to assess MammaPrint's potential predictive power. 20 percent of the 144 patients in the poor prognosis signature group achieved a pCR, whereas none of the patients with a good prognosis signature achieved a pCR. After a median follow-up of 25 months, 19 relapses were seen in the poor signature and none in the good signature group. These findings suggest tumors with a poor prognosis 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 - 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 adjuvant chemotherapy in addition to other clinical information and pathology tests.
All MammaPrint tests are conducted in Agendia's CLIA-certified service laboratory. All other breast cancer recurrence assays currently marketed 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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