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MammaPrint(R) Breast Cancer Test Provides Valuable Insight for Personalized Treatment Decisions

Results presented at major U.S. cancer conference

CHICAGO, May 30 /PRNewswire/ -- Agendia BV, a world leader in the rapidly evolving field of molecular diagnostics, announced today that data from two studies involving its MammaPrint(R) breast cancer prognosis test will be presented at the American Society of Clinical Oncology's (ASCO) annual meeting. Collectively, these findings show that MammaPrint, a prognostic test for breast cancer recurrence using a 70-gene signature, provides important information for more effective patient management.

"These studies demonstrate the clinical utility of MammaPrint in helping physicians make more informed decisions about the course of care for their patients with breast cancer," said Laura van 't Veer, Ph.D., Head of Molecular Pathology at the Netherlands Cancer Institute in Amsterdam, who participated in both studies. "Prognostic tests such as MammaPrint have ushered in a new era in personalized medicine, helping us to determine the most appropriate care based on an individual patient's risk and treatment preferences. This might mean, in some cases, avoiding harsh therapies that may otherwise not be effective."

In the first study (abstract #527), conducted at The University of Texas M.D. Anderson Cancer Center in Houston, tumor samples from 198 patients with early stage, lymph-node negative breast cancer were analyzed with multiple gene-expression assays, including MammaPrint, to determine whether both prognostic and treatment prediction data could be generated from a single specimen.

Among 32% of patients (64 of 198) predicted to be at low risk for breast cancer recurrence with MammaPrint, 31% (20 of 64) were predicted to be highly sensitive to endocrine therapy while 88% (56 of 64) were predicted to be insensitive to chemotherapy. The remaining 134 patients who were considered to be at high risk for cancer recurrence, were predominantly predicted chemo-sensitive (>51%). The abstract (Combined use of genomic prognostic and treatment response predictors in breast cancer) will be presented by Lajos Pusztai, M.D., Ph.D., associate professor of medicine at M.D. Anderson Cancer Center on June 2 at 8:00 am/12 noon.

"These findings are exciting as they suggest that different predictive tests that evaluate the risk of recurrence and therapeutic response can be used conjunctively on a single tumor sample to help physicians gain a clearer picture of a patient's treatment needs," Dr. Pusztai said. "The information gained from multiple predictive tests can be used to help physicians make more personalized decisions related to patient management. It may also be useful in helping identify additional areas for research, such as determining the best course of treatment for patients who are identified as being at high risk for breast cancer recurrence and also likely to not respond to certain treatments."

The second study (abstract #6575) was a prospective trial to assess the clinical implementation of MammaPrint in 15 community hospitals in The Netherlands. Of 427 MammaPrint gene profiles obtained from 812 patients with node-negative breast cancer, 30% of the results were discordant with the Dutch treatment guidelines. For example, some patients categorized as high risk for cancer recurrence using MammaPrint had been previously identified as low risk using the guidelines. In 54% of the discordant cases, the course of treatment was changed. The abstract (Implementation assessment of the 70-gene prognosis signature for breast cancer diagnostics) will be presented by Valesca Retel, Ph.D. student at the Netherlands Cancer Institute, on June 1 at 8:00 am.

"MammaPrint provides important information that physicians don't otherwise get through prognostic guidelines. More importantly, physicians in community-based hospitals in this trial highly valued the addition of the information provided by MammaPrint as benefiting patient management," Dr. van 't Veer said.

Both abstracts will also be published in the May 20 Supplement to the Journal of Clinical Oncology.

About MammaPrint(R)

MammaPrint(R) laboratory service is the first and only FDA cleared (February 2007) DNA microarray-based 'in vitro diagnostic multivariate index assay' (IVDMIA). MammaPrint(R) measures the activity of 70 genes, providing information about the likelihood of tumor recurrence. The MammaPrint(R) test measures the level of expression of each of these genes in a sample of a woman's surgically-removed breast cancer tumor and then uses a specific formula or algorithm to produce a score that determines whether the patient is deemed low risk or high risk for spread of the cancer to another site. The result may help a doctor in planning treatment and appropriate follow-up for a patient when used with other clinical information and laboratory tests. All MammaPrint(R) tests are conducted in Agendia's CLIA-certified central service laboratory.

About Agendia

Agendia, located in Amsterdam, The Netherlands, is a world leader in gene expression analysis-based diagnostics with three products on the market. The company focuses on the development and commercialization of diagnostic tests using tumor gene expression profiling. Agendia was the first company to commercialize a prognostic test -- MammaPrint(R) -- that predicts the risk of breast cancer recurrence. Agendia maintains close ties with several leading academic centers to develop state of the art diagnostic tests for cancer. Agendia also offers its expertise to pharma companies focusing on development of highly effective personalized drugs in the area of oncology. For more information on Agendia, please visit .


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Agendia BV


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