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Study Shows MammaPrint(R) Breast Cancer Test Provides Benefits to Patients from Personalized Treatment Regimen
Date:12/14/2007

- New Lancet Oncology publication provides important insights on the use of

MammaPrint(R) Breast Cancer Prognosis Test in clinical practice -

AMSTERDAM, The Netherlands, Dec. 14 /PRNewswire/ -- New research demonstrates that the MammaPrint(R) breast cancer prognosis test was successfully implemented in the diagnostic process of breast cancer patients in community hospitals in The Netherlands. MammaPrint(R) assigned up to one- third of the patients to different risk categories as compared to currently used risk assessment tools. In the majority of these situations, it may lead to a reduction in the use of adjuvant chemotherapy. The findings were published in the December issue of The Lancet Oncology.

In the study, breast tumors from 585 patients with lymph node-negative, invasive breast cancer, collected at 16 hospitals in The Netherlands. Fresh samples were shipped in RNAretain(R)* at ambient temperature and were subjected at Agendia Laboratories to MammaPrint(R) gene expression analysis. Results were available for 427 patients. Based on this, patients were classified as having either a poor prognosis (high risk for distant metastasis) or good prognosis (low risk for metastasis). These results were then compared by the study coordinators to risk assessments of commonly used guidelines, including the Dutch Institute for Health Improvement (Dutch CBO) Guidelines, St. Gallen Guidelines, Nottingham Prognostic Index, and Adjuvant! Online. Many guidelines use algorithms (based on the patient's age, tumor size, and node status) to determine a patient's prognosis and determine whether or not patients should receive chemotherapy.

"More than 70 percent of patients who have node-negative breast cancer are successfully treated without chemotherapy. Identifying which patients with breast cancer will most likely require adjuvant chemotherapy is an important step in personalizing a patient's treatment regimen, and ensuring that patients aren't receiving unnecessary treatment," said Dr Laura van 't Veer, chief research officer at Agendia, who participated in the study.

According to the results in The Lancet Oncology, adjuvant chemotherapy was advised less often when the patient's prognosis was based on the DUTCH CBO Guidelines -- which are considered the most restrictive -- compared with assessments based on MammaPrint(R). For the other guidelines assessed, however, less adjuvant therapy would be given based on the prognosis of MammaPrint(R). These results confirm previous findings and validations with the test.

"These data provide important information to patients and physicians that can effectively help guide treatment decisions in community-based hospitals. The prognosis provided by MammaPrint(R), together with guidance from clinical guidelines and patients' treatment preferences, are vital tools for physicians caring for breast cancer patients," said Bernhard Sixt, chief executive officer at Agendia.

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 http://www.agendia.com.

* RNARetain(R) is a trademark of Asuragen Inc.


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