HUNTINGTON BEACH, California and AMSTERDAM, December 12 Agendia, a world leader in molecular cancer diagnostics, today announcedMammaPrint(R)'s ability to predict response to neoadjuvant chemotherapy inbreast cancer.
Dr. Laura van 't Veer, from the Netherlands Cancer Institute, presentedthe data at the 2008 San Antonio Breast Cancer Symposium (SABCS) during thesession Molecular profiling for guiding therapeutic decisions. The studyanalyzed the association between the pathological complete response (pCR)rate and the results of the MammaPrint test.
"Physicians are increasingly supportive of MammaPrint in clinicalpractice because they believe it provides them with invaluable informationfor patient treatment planning. MammaPrint's ability to accurately determinehigh risk patient responsiveness to chemotherapy both confirm and speak tothe confidence physicians express in this state-of-the-art genomic breastcancer test," commented Dr. Richard Bender, Chief Medical Officer of Agendiaand a life-long practicing oncologist who made a career at the NCI, KaiserPermanente and Quest Diagnostics.
Findings in the neoadjuvant setting support MammaPrint's predictive powerfor chemotherapy response, in addition to its previously demonstratedprognostic value for early stage disease. The achievement of pCR is avaluable indicator for long-term response in this clinical setting.
A consecutive series of 167 patients who received neoadjuvantchemotherapy for stage II or III breast cancer were analyzed to assessMammaPrint's potential predictive power. 20 percent of the 144 patients inthe poor prognosis signature group achieved a pCR, whereas none of thepatients with a good prognosis signature achieved a pCR. After a medianfollow-up of 25 months, 19 relapses were seen in the poor signature and nonein the good signature group. These findings suggest tumors with a poorprognosis 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). FDAclearance requires clinical and analytical validation and reporting systemsto ensure patient safety issues are addressed. Highly accurate, MammaPrintidentifies patients with early metastasis - those patients who are likely todevelop metastases within five years following surgery. Several authoritativestudies have shown that chemotherapy particularly reduces early metastasisrisk. In planning treatment, the MammaPrint test result provides a doctorwith a clear rationale to assess the benefit of adjuvant chemotherapy inaddition to other clinical information and pathology tests.
All MammaPrint tests are conducted in Agendia's CLIA-certified servicelaboratory. All other breast cancer recurrence assays currently marketed havenot 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 ofpatients. Building on a cutting edge genomics platform for tumor geneexpression profiling, the company's tests aim to help physicians moreaccurately tailor cancer treatments. The company markets four products, withseveral new genomic tests under development. In addition, Agendiacollaborates with pharmaceutical companies to develop highly effectivepersonalized drugs in the area of oncology. Agendia is based in HuntingtonBeach, California, and in Amsterdam, The Netherlands. For more informationplease visit http://www.agendia.com.
SOURCE Agendia BV